Food and Drug Administration
FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs Gao ID: GAO-09-581 June 19, 2009Twenty years ago, GAO reported that the Food and Drug Administration (FDA) was concerned that it lacked resources to fulfill its mission, which includes oversight of the safety and effectiveness of medical products--human drugs, biologics, and medical devices--marketed for sale in the United States. Since then, FDA, GAO, and others have raised concerns regarding FDA's ability to meet its oversight responsibilities. GAO was asked to review the resources supporting FDA's medical product oversight responsibilities. GAO examined trends in (1) FDA's funding and staffing resources for its medical product oversight responsibilities from fiscal years 1999 through 2008, and (2) FDA's medical product oversight responsibilities during this same period. GAO analyzed FDA data on the agency's resources and workload, reviewed relevant federal laws, and interviewed FDA officials. GAO also examined more-detailed data on FDA's fiscal year 2004 through 2008 resources and workload in four key areas, representing a range of FDA's oversight responsibilities, both before and after a medical product is marketed in the United States.
Funding and staffing resources for FDA's medical product programs increased between fiscal years 1999 and 2008, primarily as a result of increased user fees paid by industry, which are made available through appropriations acts to support the agency's processes for reviewing new medical products. Total funding increased from about $562 million in fiscal year 1999 to about $1.2 billion in fiscal year 2008, with user fee funding accounting for more than half of this increase. A large and growing portion of funding supported activities for which user fees are collected, resulting in a declining share of funding available for other activities. FDA officials said that this has seriously limited the agency's ability to fulfill its oversight responsibilities in some areas, particularly those not funded with user fees. FDA faced challenges fulfilling and managing its growing medical product oversight responsibilities, which agency officials attributed to resource constraints. FDA's statutory responsibilities grew during this period and a growing number of medical products subject to FDA oversight and establishments manufacturing these products for the U.S. market also added to the agency's workload. However, FDA could not provide data showing its workload and accomplishments in some areas, such as its review of reports identifying potential safety issues with specific medical products. Without such information, FDA cannot develop complete and reliable estimates of its resource needs. While FDA officials said that the funding amounts requested for and provided to FDA during the past 2 years will permit the agency to respond to its most urgent needs and priorities, officials also noted that they did not receive enough resources to meet some statutory requirements, such as biennially inspecting certain manufacturing establishments. Furthermore, officials said that the agency faces significant challenges fulfilling its mission to oversee the safety and effectiveness of medical products.
RecommendationsOur recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.
Director: Team: Phone:GAO-09-581, Food and Drug Administration: FDA Faces Challenges Meeting Its Growing Medical Product Responsibilities and Should Develop Complete Estimates of Its Resource Needs
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Report to Congressional Requesters:
United States Government Accountability Office:
GAO:
June 2009:
Food and Drug Administration:
FDA Faces Challenges Meeting Its Growing Medical Product
Responsibilities and Should Develop Complete Estimates of Its Resource
Needs:
FDA's Medical Product Resources:
GAO-09-581:
GAO Highlights:
Highlights of GAO-09-581, a report to congressional requesters.
Why GAO Did This Study:
Twenty years ago, GAO reported that the Food and Drug Administration
(FDA) was concerned that it lacked resources to fulfill its mission,
which includes oversight of the safety and effectiveness of medical
products”human drugs, biologics, and medical devices”marketed for sale
in the United States. Since then, FDA, GAO, and others have raised
concerns regarding FDA‘s ability to meet its oversight
responsibilities.
GAO was asked to review the resources supporting FDA‘s medical product
oversight responsibilities. GAO examined trends in (1) FDA‘s funding
and staffing resources for its medical product oversight
responsibilities from fiscal years 1999 through 2008, and (2) FDA‘s
medical product oversight responsibilities during this same period. GAO
analyzed FDA data on the agency‘s resources and workload, reviewed
relevant federal laws, and interviewed FDA officials. GAO also examined
more-detailed data on FDA‘s fiscal year 2004 through 2008 resources and
workload in four key areas, representing a range of FDA‘s oversight
responsibilities, both before and after a medical product is marketed
in the United States.
What GAO Found:
Funding and staffing resources for FDA‘s medical product programs
increased between fiscal years 1999 and 2008, primarily as a result of
increased user fees paid by industry, which are made available through
appropriations acts to support the agency‘s processes for reviewing new
medical products. Total funding increased from about $562 million in
fiscal year 1999 to about $1.2 billion in fiscal year 2008, with user
fee funding accounting for more than half of this increase. A large and
growing portion of funding supported activities for which user fees are
collected, resulting in a declining share of funding available for
other activities. FDA officials said that this has seriously limited
the agency‘s ability to fulfill its oversight responsibilities in some
areas, particularly those not funded with user fees.
Figure: Portion of Total Medical Product Program Funding Allocated to
User Fee and Other Activities, Fiscal Years 1999 and 2008:
[Refer to PDF for image: two pie-charts]
Fiscal year 1999:
User fee activities: 48%;
Other activities: 52%.
Fiscal year 2008:
User fee activities: 69%;
Other activities: 31%.
Source: GAO analysis of FDA data.
[End of figure]
FDA faced challenges fulfilling and managing its growing medical
product oversight responsibilities, which agency officials attributed
to resource constraints. FDA‘s statutory responsibilities grew during
this period and a growing number of medical products subject to FDA
oversight and establishments manufacturing these products for the U.S.
market also added to the agency‘s workload. However, FDA could not
provide data showing its workload and accomplishments in some areas,
such as its review of reports identifying potential safety issues with
specific medical products. Without such information, FDA cannot develop
complete and reliable estimates of its resource needs. While FDA
officials said that the funding amounts requested for and provided to
FDA during the past 2 years will permit the agency to respond to its
most urgent needs and priorities, officials also noted that they did
not receive enough resources to meet some statutory requirements, such
as biennially inspecting certain manufacturing establishments.
Furthermore, officials said that the agency faces significant
challenges fulfilling its mission to oversee the safety and
effectiveness of medical products.
What GAO Recommends:
GAO recommends that the Commissioner of FDA take steps to establish a
comprehensive and reliable basis for substantiating the agency‘s
resource needs. FDA agreed with our recommendations.
View [hyperlink, http://www.gao.gov/products/GAO-09-581] or key
components. For more information, contact Marcia Crosse at (202) 512-
7114 or crossem@gao.gov.
[End of section]
Contents:
Letter:
Background:
Driven by User Fees, Funding and Staffing for Medical Product Programs
Have Increased, Although FDA Is Concerned about Staffing Levels:
FDA Faced Challenges Fulfilling and Managing Its Growing Medical
Product Oversight Responsibilities, Citing Resource Constraints:
Conclusions:
Recommendations for Executive Action:
Agency Comments:
Appendix I: Funding and Staffing Resources for FDA Medical Product
Programs, Fiscal Years 1999 through 2008:
Appendix II: Trends in Center and Field Resources for the Drugs,
Biologics, and Devices Programs:
Appendix III: Trends in FDA's Review of Generic Drug, New Drug and New
Biologic Applications:
Appendix IV: Trends in FDA Inspections Conducted to Oversee Medical
Product Research and Manufacturing:
Appendix V: Trends in FDA's Review of Adverse Event Reports:
Appendix VI: Trends in FDA's Examination of Advertising and Promotional
Materials:
Appendix VII: Comments from the Department of Health and Human
Services:
Appendix VIII: GAO Contact and Staff Acknowledgments:
Related GAO Products:
Tables:
Table 1: Percentage Increase in Fiscal Year Appropriations, User Fee
Funding, and Total Funding for FDA, Fiscal Years 1999 through 2008:
Table 2: Number of Domestic and Foreign Establishments Registered to
Produce Medical Products for the U.S. Market, Fiscal Years 1999 and
2008:
Table 3: FDA's Estimated Frequency of Inspections for Selected
Establishment Types:
Table 4: Funding Resources for FDA Programs, Fiscal Years 1999 through
2008:
Table 5: Staffing Resources for FDA Programs, Fiscal Years 1999 through
2008:
Table 6: Medical Product Program Funding Resources for Center and Field
Activities, Fiscal Years 2004 through 2008:
Table 7: Medical Product Program Staffing Resources for Center and
Field Activities, Fiscal Years 2004 through 2008:
Table 8: Elements of FDA's Oversight Work Related to the Process of
Reviewing ANDAs, Fiscal Years 2004 through 2008:
Table 9: Elements of FDA's Oversight Work Related to the Process of New
Drug Development and Application Review, Fiscal Years 2004 through
2008:
Table 10: Number of Domestic and Foreign Inspections for the Drugs,
Biologics, and Devices Programs, Fiscal Years 2004 through 2008:
Figures:
Figure 1: Federal Government, HHS, and FDA Funding, Fiscal Year 2008:
Figure 2: Annual Medical Product Program Funding from Fiscal Year
Appropriations and User Fees, Fiscal Years 1999 through 2008:
Figure 3: Portion of Total Medical Product Program Funding Allocated to
User Fee Activities and Other Program Activities, Fiscal Years 1999 and
2008:
Figure 4: Annual Medical Product Program Staffing Resources from Fiscal
Year Appropriations and User Fees, Fiscal Years 1999 through 2008:
Figure 5: Timeline of 11 Laws Enacted between 2002 and 2007 That
Increased FDA's Medical Product Oversight Responsibilities:
Figure 6: Trends in Medical Product Applications, Resubmitted
Applications, and Application Supplements Submitted to FDA, Fiscal
Years 1999 through 2008:
Figure 7: Annual Medical Product Program Funding for Center and Field
Activities, Fiscal Years 2004 through 2008:
Figure 8: Annual Medical Product Program Staffing Resources for Center
and Field Activities, Fiscal Years 2004 through 2008:
Figure 9: Medical Product Program Inspections, Fiscal Years 2004
through 2008:
Figure 10: Annual Funding Resources for Medical Product Program
Inspections, Fiscal Years 2004 through 2008:
Figure 11: Annual Staffing Resources for Medical Product Program
Inspections, Fiscal Years 2004 through 2008:
Figure 12: Funding for Adverse Event Reviews Related to Drugs,
Biologics, and Devices, Fiscal Years 2004 through 2008:
Abbreviations:
ANDA: abbreviated new drug application:
BLA: biologics license application:
CBER: Center for Biologics Evaluation and Research:
CDER: Center for Drug Evaluation and Research:
CDRH: Center for Devices and Radiological Health:
CRS: Congressional Research Service:
FDA: Food and Drug Administration:
FDAAA: Food and Drug Administration Amendments Act of 2007:
FTE: full-time equivalent:
GDP: gross domestic product:
HHS: Department of Health and Human Services:
IND: investigational new drug:
MDUFMA: Medical Device User Fee and Modernization Act of 2002:
NDA: new drug application:
OMB: Office of Management and Budget:
ORA: Office of Regulatory Affairs:
PDUFA: Prescription Drug User Fee Act of 1992:
PREA: Pediatric Research Equity Act of 2003:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
June 19, 2009:
Congressional Requesters:
Twenty years ago, we reported that the Food and Drug Administration
(FDA), an agency of the Department of Health and Human Services (HHS),
was concerned that it lacked sufficient funding and staffing resources.
[Footnote 1] FDA reported that its lack of resources prevented it from
adequately fulfilling its mission, which includes overseeing the safety
and effectiveness of medical products--human drugs, biologics,[Footnote
2] and medical devices[Footnote 3]--marketed for sale in the United
States.[Footnote 4] We concluded that, while the agency was
experiencing significant resource challenges, it lacked a comprehensive
and reliable basis to substantiate its estimates of resource
requirements. On several occasions since then, senior FDA officials
have testified before Congress and the agency issued a report noting
that the agency's funding and staffing resources do not enable it to
meet its growing oversight responsibilities.[Footnote 5]
Lingering questions regarding the agency's resources have added to
concerns about FDA's ability to protect Americans from unsafe and
ineffective medical products. FDA's Science Board reported in November
2007 that the agency could not fulfill its growing responsibilities
because it did not have sufficient resources.[Footnote 6] In fiscal
years 2007 and 2008, the HHS Office of Inspector General listed FDA's
oversight of drug and device safety as one of the department's top
management and performance challenges in HHS' annual financial reports.
[Footnote 7] And in January 2009, we added FDA's oversight of medical
products to our High-Risk Series, which is intended to raise the
priority and visibility of government programs that are in need of
broad-based transformation to address major economy, efficiency, or
effectiveness challenges.[Footnote 8]
To enhance its ability to meet its mission, particularly to address
challenges related to the globalization of medical product development
and manufacturing, FDA requested an additional appropriation from
Congress in May 2008. This request was designed to supplement resources
for, among other things, FDA's three medical product programs--the
drugs, biologics, and devices programs. In June 2008, the
administration officially amended its fiscal year 2009 budget request
for FDA to include an additional $100 million for these programs.
Questions have been raised regarding the sufficiency of the resources
available to FDA to fulfill its medical product oversight
responsibilities, including recurring responsibilities required by
statute, such as inspecting certain manufacturing establishments at
prescribed intervals. This report examines (1) trends in FDA's funding
and staffing resources for its medical product programs from fiscal
year 1999 through fiscal year 2008, and (2) trends in FDA's medical
product oversight responsibilities from fiscal year 1999 through fiscal
year 2008.
To examine trends in FDA's funding and staffing resources, we reviewed
funding and staffing data as reported in FDA's congressional budget
justifications for the agency's medical product programs from fiscal
years 1999 through 2008. We compared changes in funding for FDA's
medical product programs to the 10-year inflation rate as measured by
the gross domestic product (GDP) price index for nondefense goods and
services.[Footnote 9] We reviewed Office of Management and Budget (OMB)
data on HHS and federal government funding for fiscal years 1999
through 2008 and compared trends in HHS and federal government funding
to trends in FDA funding over this period. We reported staffing
resources by the number of full-time equivalent (FTE) staff; one FTE
represents 40 hours of work per week conducted by a federal government
employee over the course of 1 year. FTEs do not include contractors and
therefore provide a partial measure of staffing resources. We reviewed
HHS' online employee directory as of March 2009 to obtain an estimate
of the number of contractors working with FDA's medical product
programs. We also interviewed FDA officials regarding trends in hiring,
retention, and retirement, and the effect of funding and staffing
resource trends on the agency's ability to meet its medical product
oversight responsibilities. To supplement our analysis of trends in
FDA's resources from fiscal years 1999 through 2008, we obtained and
reviewed more-detailed data on how the agency used its funding and
staffing resources for specific activities within the three medical
product programs during a shorter time period, fiscal years 2004
through 2008. For these areas, we compared changes in funding levels to
the 5-year inflation rate as measured by the GDP price index.
To examine trends in FDA's medical product oversight responsibilities
from fiscal year 1999 through fiscal year 2008, we reviewed changes in
the volume of work that FDA was responsible for conducting related to
its oversight of medical products. To determine if FDA's
responsibilities changed during this time period, we reviewed FDA
documents and Congressional Research Service (CRS) reports identifying
laws that affected FDA's medical product responsibilities and we also
examined those federal laws. We did not conduct a comprehensive search
of all federal laws. To review trends in the volume of FDA's work
related to its oversight responsibilities, we analyzed FDA data on the
number of medical product applications and other materials submitted to
the agency for review between fiscal years 1999 and 2008. We also
reviewed FDA data on the cumulative number of medical products approved
or cleared for marketing in the United States and the number of
establishments registered with the agency to produce marketed medical
products--a proxy for the number of establishments subject to FDA
oversight and inspection--in fiscal years 1999 and 2008.[Footnote 10]
We interviewed FDA officials to obtain detailed information on how
changes in the agency's medical product oversight responsibilities
affected the amount of work it conducted over this 10-year period.
To supplement our examination of trends in FDA's medical product
oversight resources and responsibilities, we reviewed FDA's oversight
of four key areas within its three medical product programs for a
shorter time period--fiscal years 2004 through 2008. We selected these
four areas to represent a broad range of the agency's medical product
oversight responsibilities, including FDA's oversight responsibilities
both before and after a product is marketed in the United States, and
areas funded with and without user fees. The four key areas we examined
were FDA's (1) review of generic drug, new drug, and new biologic
applications, (2) inspections of medical product research activities
and manufacturing establishments, (3) review of adverse event[Footnote
11] reports, and (4) examination of advertising and promotional
materials. For each key area, we interviewed FDA officials and analyzed
FDA data on the resources it used to conduct its work during this
period.
To further examine trends in FDA's responsibilities, we examined the
extent to which the agency met selected statutory requirements and
performance goals that set expectations for FDA between fiscal years
2004 and 2008 in two of the four key areas we reviewed--FDA's review of
generic drug, new drug, and new biologic applications, and inspections
of medical product research activities and manufacturing
establishments.[Footnote 12] Specifically, we reviewed FDA data on the
timeliness of the agency's review of generic drug applications compared
with a statutory requirement that the agency review these applications
within a certain time frame. We reviewed published FDA reports and FDA
data on the timeliness of the agency's review of new drug and new
biologic applications compared with certain performance goals. We also
examined FDA's estimated inspection frequency for six types of
establishments--domestic drug manufacturing, foreign drug
manufacturing, domestic blood banks, domestic human tissue banks,
domestic device manufacturing, and foreign device manufacturing. We
selected these six types of establishments because they included
inspections for drugs, biologics, and devices, and because they also
include establishment types with and without statutory requirements
regarding the frequency of inspections. We provide FDA's estimated
inspection frequency because, as we have noted in prior reports, FDA
does not know how many establishments are subject to inspection, and
therefore the percentage of those that have been inspected cannot
always be calculated with certainty.[Footnote 13] The results of our
review of these four key areas were used to provide detailed
illustrations that are neither representative of all agency activities
nor generalizable to the agency as a whole.
To assess the reliability of FDA data on funding, staffing, and
workload, we discussed the data with the responsible agency officials,
reviewed related documentation, and examined the data for consistency.
We determined that FDA data were sufficiently reliable for their use in
this report.
We conducted this performance audit from April 2008 to June 2009 in
accordance with generally accepted government auditing standards. Those
standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.
Background:
FDA receives annual appropriations to conduct its medical product
responsibilities; these appropriations include amounts derived from
user fees paid by industry in connection with FDA activities. FDA's
medical product responsibilities include oversight of the safety and
effectiveness of medical products marketed for sale in the United
States, regardless of whether they are manufactured domestically or
overseas. The agency's role is far-reaching and its responsibilities
include oversight of medical products both before and after they are
marketed in the United States.
FDA Funding and Organization:
Each year, the request for FDA's resources is submitted to Congress as
part of the President's Budget request. FDA develops and submits
supporting information for the request in the budget justification that
is submitted to the subcommittees with jurisdiction over FDA funding as
part of the annual appropriations process. This information reflects
how FDA proposes to meet its mission, goals, and objectives and assists
Congress in understanding whether FDA will require significant changes
in levels of appropriations. Guidance issued by OMB, which assists the
President in overseeing the preparation of the federal budget, directs
agencies to incorporate the cost of fulfilling all statutory
requirements and responsibilities in their submissions to OMB for
consideration in developing the President's Budget request. We have
also issued guidance on the development of comprehensive and reliable
resource estimates, which includes recognition of the basic elements of
such estimates. For example, these elements include complete and
reliable data, such as data on the agency's current resources, workload
and performance; provisions for program uncertainties; adjustment for
inflation; recognition of any exclusions; and an independent review of
the estimates.[Footnote 14]
In fiscal year 2008, FDA's funding totaled $2.2 billion. Of this
amount, about $500 million was derived from user fees collected from
industry and made available until expended.[Footnote 15] The remaining
amounts, about $1.7 billion, were derived from the General Fund of the
Treasury and available during fiscal year 2008.[Footnote 16] Both user
fee funding and fiscal year appropriations are made available through
the annual appropriations process.[Footnote 17] About $1.2 billion--
over half of FDA's total funding--supported its medical product
programs, including about $750 million in fiscal year appropriations
and about $440 million in user fee funding.[Footnote 18] Over half of
this funding--$681 million--supported the drug program, while $234
million supported the biologics program and $275 million supported the
devices program.
FDA's total funding is a small portion of federal government and HHS
funding. In fiscal year 2008, the federal government's funding totaled
approximately $3 trillion, of which about $722 billion was made
available to fund HHS activities, including those at FDA. These amounts
reflect both discretionary spending and mandatory spending.[Footnote
19] (See figure 1.) All of FDA's programs involve discretionary
spending.
Figure 1: Federal Government, HHS, and FDA Funding, Fiscal Year 2008:
[Refer to PDF for image: illustration]
Federal Government funding, including HHS: $3 trillion;
HHS funding, including FDA: $722 billion;
FDA funding, including all programs: $2.2 billion:
* $1.7 billion, fiscal year appropriations;
* $500 million, user fee funding.
FDA Funding:
With its fiscal year appropriations and user fee funding, FDA's fiscal
year 2008 funding totaled $2.2 billion, and over half of this amount--
about $1.2 billion--supported its medical product programs. Below are
the program funding levels:
Program: Drugs program;
Funding: $681 million.
Program: Biologics program;
Funding: $234 million.
Program: Devices program;
Funding: $275 million.
Program: Other programs (primarily food programs);
Funding: $1.055 billion.
Source: GAO analysis of FDA and OMB data.
Note: Federal government and HHS funding amounts reflect discretionary
and mandatory spending for fiscal year 2008. Specifically, about $1.2
trillion of the federal government's $3 trillion total funding
represents discretionary spending, and about $72 billion of HHS' $722
billion total funding represents discretionary spending. All of FDA's
fiscal year 2008 funding represents discretionary spending.
[End of figure]
User fees are paid in connection with FDA's drugs, biologics, and
devices programs' review of applications for new medical products and
inspections of mammography facilities.[Footnote 20] The Prescription
Drug User Fee Act of 1992 (PDUFA) was enacted to expedite the review of
applications for new drugs and new biologics.[Footnote 21] PDUFA
authorized FDA to collect user fees from drug and biologic sponsors,
typically manufacturers, to support the process of reviewing new drug
applications (NDA) and biologics license applications (BLA). Likewise,
the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
authorized FDA to collect user fees from device sponsors to support the
process of reviewing applications for certain new devices.[Footnote 22]
In both cases, FDA's authority to collect fees and use the amounts
collected must be provided in appropriations acts. Both PDUFA and
MDUFMA require FDA to apply all user fee funding to support the
agency's process for reviewing applications for certain new medical
products, and preclude the agency from using this funding for other
agency activities. In fiscal year 2008, agency activities not funded
with user fees included, for example, the agency's oversight of the
safety of human tissues, review of applications for generic drugs,
inspections unrelated to the agency's review of new medical products,
and some postmarket safety oversight activities.[Footnote 23] PDUFA and
MDUFMA user fee funding only partially covers FDA's costs for reviewing
applications for certain new medical products and associated
activities. FDA is also required to use a specified amount of its
fiscal year appropriations to support its review of these applications.
[Footnote 24]
Within FDA, three centers have primary responsibility for ensuring the
safety and effectiveness of medical products. The Center for Biologics
Evaluation and Research (CBER) is responsible for overseeing biologics;
the Center for Drug Evaluation and Research (CDER) is responsible for
overseeing drugs and some therapeutic biologics;[Footnote 25] and the
Center for Devices and Radiological Health (CDRH) is responsible for
overseeing devices and for ensuring that radiation-emitting products,
such as microwaves and x-ray machines, meet radiation safety standards.
Among other things, these centers evaluate the safety and effectiveness
of new medical products prior to marketing, monitor the safety and
effectiveness of marketed products, oversee the advertising and
promotion of marketed products, formulate regulations and guidance,
conduct research, communicate information to industry and the public,
and set their respective medical product program's priorities. In
addition to the work of the three centers, the Office of Regulatory
Affairs (ORA) conducts field activities for all of FDA's product
centers. Field activities include conducting inspections of domestic
and foreign establishments involved in manufacturing medical products,
examining medical products offered for import, and collecting and
analyzing samples. Medical product program resources include funding
for center activities and field activities. Center activity funding
represents funding for the three centers--CDER, CBER, or CDRH--and
field activity funding represents ORA funding for all medical product
programs.
FDA's Medical Product Oversight Responsibilities:
As part of its oversight responsibilities, FDA reviews applications
submitted by manufacturers for medical products they wish to market in
the United States to ensure that new products are safe and effective,
inspects establishments producing medical products to ensure
manufacturing processes meet quality standards, reviews reports of
adverse events to monitor the safety of marketed medical products, and
examines advertising and other promotional materials to ensure they are
not false and misleading.
Oversight of New Medical Products:
FDA's oversight of medical product safety and effectiveness typically
begins when medical product sponsors develop a new product, long before
such products are marketed for sale. For example, FDA requires sponsors
to submit an investigational new drug (IND) application before
beginning clinical trials (studies in humans) of a new drug or new
biologic. The IND application provides FDA with extensive information
about the product, including safety and manufacturing information about
the product, and outlines the sponsor's plans for clinical trials. FDA
assesses this preliminary information to ensure that the product is
reasonably safe to begin studying in humans. While FDA does not issue a
formal approval to the sponsor regarding an IND application, it can
prohibit the start of a clinical trial by placing it on hold if, for
example, the agency determines that human volunteers would be exposed
to an unreasonable and significant risk of illness or injury.[Footnote
26]
Sponsors often request guidance and feedback from FDA during the
process of drug and biologic development. Before and during clinical
trials, FDA may meet with sponsors to provide guidance on the design of
the clinical trial. In addition, FDA may issue a written evaluation of
particular aspects of a clinical trial--known as a special protocol
assessment. FDA may also meet with sponsors after the completion of a
successful clinical trial to discuss the information the agency would
expect to see submitted to the agency for marketing approval.
FDA's approval is required before new drugs and biologics can be
marketed for sale in the United States.[Footnote 27] To obtain FDA's
approval, sponsors must submit an application containing data on the
safety and effectiveness of their new medical product as determined
through clinical trials and other research. For example, sponsors must
request approval for a new drug or new biologic by submitting an NDA or
BLA. FDA reviews data included in these applications to determine
whether the product is safe and effective for its intended use. FDA
also examines proposed product labeling to ensure that it clearly
states the condition and population the product is intended to treat.
After completing its assessment of the information in the application
and any subsequent submissions of additional information, known as
application resubmissions, FDA determines whether to approve the
product for marketing. After FDA approves a product, manufacturers
requesting changes to product labeling, manufacturing, dosing, or usage
must submit an application supplement to obtain FDA approval.
In addition to its responsibility for approving new drugs prior to
marketing, FDA approval is also required before generic drugs--drugs
that are copies of already approved new drugs--can be marketed for sale
in the United States. Sponsors of generic drugs may obtain FDA approval
by submitting an abbreviated new drug application (ANDA) to the agency
for review. The ANDA contains data showing, among other things, that
the generic drug is bioequivalent to, or performs in the same manner
as, a drug approved through the NDA process.[Footnote 28] Similar to
its review of NDAs, FDA reviews information submitted in the
application, including proposed product labeling. To request FDA
approval of proposed changes to product labeling, manufacturing,
dosing, or usage after a generic drug is approved, sponsors must submit
an ANDA supplement.
FDA is also responsible for overseeing the safety and effectiveness of
devices. Devices are classified into one of three classes--class I, II,
or III--based on the level of risk posed to the patient or user and the
controls necessary to reasonably ensure safety and effectiveness. Class
I devices are those that pose the lowest risk, and class III devices
are those that pose the highest risk.[Footnote 29] Some devices are
subject to one of two types of FDA review before they may be marketed
for sale in the United States.[Footnote 30] Some class II devices are
required to obtain FDA clearance through a premarket notification
process, whereby a sponsor must demonstrate to FDA that the new device
is substantially equivalent to a device that FDA previously approved or
cleared for marketing. In contrast, class III devices are generally
required to obtain FDA approval through a more stringent premarket
approval process, whereby a sponsor must provide evidence, typically
including clinical data, to demonstrate with reasonable assurance that
the new device is safe and effective. As with new drugs and biologics,
FDA's review of these applications includes an assessment of product
labeling and usage.
FDA is required to review certain medical product applications within
specified time frames. For example, FDA is generally required to review
NDAs, BLAs, and ANDAs within 180 days of receipt.[Footnote 31] PDUFA
also established performance goals to speed up FDA's process for
reviewing NDAs and certain BLAs. These performance goals can be grouped
into three main categories--those related to the speed at which the
agency (1) reviews applications and supplemental materials, (2)
schedules and holds meetings with sponsors, and (3) issues written
guidance as requested by sponsors.[Footnote 32] Multiple performance
goals exist within each of these broad categories. For example, one
performance goal is that FDA review and act on 90 percent of certain
NDAs and BLAs within 10 months of their receipt; another is that FDA
schedule 90 percent of certain meetings with sponsors within 30 days of
receiving the sponsor's meeting request. In addition, MDUFMA also
established similar types of performance goals related to the
timeliness of FDA's process for reviewing applications for new devices
subject to the premarket approval and premarket notification process.
Inspections Conducted to Oversee Medical Product Research and
Manufacturing:
As part of its oversight responsibilities, FDA conducts inspections of
domestic and foreign establishments. Specifically, FDA conducts
inspections of clinical trial sites to ensure the protection of human
subjects and the accuracy and validity of clinical trial data reported
to the agency. FDA also inspects medical product manufacturing
establishments to ensure that manufacturing processes adhere to current
good manufacturing practices requirements and regulations.[Footnote 33]
Inspections of manufacturing establishments may occur before medical
products are marketed in the United States. To ensure continued
adherence to current good manufacturing practices requirements, FDA may
also inspect establishments after the product is on the market.
FDA is required to inspect certain types of establishments with a
particular frequency; however, requirements governing the frequency of
these inspections differ. For example, FDA is required to conduct
inspections of certain types of establishments every 2 years--including
domestic drug and device manufacturers, as well as domestic blood
banks.[Footnote 34] However, there are no comparable requirements
regarding the frequency with which FDA should conduct inspections of
other types of domestic establishments, such as domestic human tissue
banks, or some foreign establishments, including those manufacturing
drugs and devices marketed for sale in the United States. FDA does not
have the authority to require foreign establishments to allow the
agency to inspect their facilities. However, FDA has the authority to
prevent the importation of products manufactured at establishments that
refuse to allow an FDA inspection.[Footnote 35]
Oversight of Adverse Event Reporting:
Because no medical products are absolutely safe--there is always some
risk of an adverse event--FDA continues to assess products' risks and
benefits after the products are on the market by using multiple
strategies. One such strategy is to collect and analyze adverse event
reports related to the use of medical products and monitor them to
identify potential safety issues associated with the use of a specific
medical product. FDA receives adverse event reports from various
sources, including medical product manufacturers, physicians, and the
public. FDA requires medical product manufacturers and others to submit
reports of adverse events associated with the use of a medical product
to FDA at certain frequencies depending on the seriousness of the
adverse event and the amount of time the product has been on the
market.[Footnote 36] Physicians and the public may voluntarily submit
reports of adverse events to FDA at any time. The agency's review of
these reports helps to identify, among other things, unexpected adverse
events, product quality problems, and product use errors related to
marketed medical products. These reviews provide information that may
lead FDA to require the product's sponsor to conduct a safety study,
make changes to product labeling, or recall a product from the market.
Oversight of Advertising and Promotional Activities:
FDA oversees the advertising and promotion of prescription drugs,
biologics, and some devices to ensure that information disseminated
about medical products is not false or misleading.[Footnote 37] FDA
regulations also require that product promotions include a balanced
disclosure of side effects, contraindications, and warnings.[Footnote
38] In addition, advertising and promotions may not recommend or
suggest any use of a product that is not included in the product's
approved labeling. FDA regulates the content of advertising and
promotions regardless of whether they are directed toward consumers or
medical professionals.
FDA regulations require manufacturers to submit to the agency all final
advertising and promotional materials for drugs and biologics at the
time the materials are first disseminated to the public.[Footnote 39]
In contrast, FDA does not require manufacturers to submit advertising
and promotional materials for devices at the time of their initial
dissemination. Companies may also voluntarily submit draft advertising
and promotional materials to FDA prior to their public release in order
to obtain advisory comments from the agency. Although FDA is not
required to review all materials submitted, reviewing final and draft
advertising and promotional materials is the agency's primary mechanism
for ensuring that information disseminated about drug and biologic
products is not false or misleading.
To supplement its examination of submitted materials, FDA staff also
monitor the content of disseminated advertising and promotional
materials, for example, by attending medical conferences, reviewing
company Web sites, and following up on complaints received.
Driven by User Fees, Funding and Staffing for Medical Product Programs
Have Increased, Although FDA Is Concerned about Staffing Levels:
Funding and staffing for FDA's medical product programs have increased
mostly as a result of user fee funding, which is primarily directed
toward the agency's review of new medical products. FDA is required to
apply a certain amount of its fiscal year appropriations to support
user fee activities, and agency officials said that this requirement
limits the resources available for other medical product program
activities that are not supported by user fee funding. In addition to
their concerns about the sufficiency of their resources, FDA officials
are concerned about the agency's ability to hire and retain staff in
certain scientific occupations.
Medical Product Program Funding Has Increased, Largely Due to User
Fees:
Funding for FDA's medical product programs increased between fiscal
year 1999 and fiscal year 2008, mostly due to increases in user fee
funding. Medical product program funding increased 112 percent overall,
from about $562 million in fiscal year 1999 to about $1.2 billion in
fiscal year 2008.[Footnote 40] (See figure 2.) This funding increase
was greater than the GDP rate of inflation across this time period--25
percent. Over half of the increase in medical product program funding
was due to growth in user fee funding, which grew four times as fast as
fiscal year appropriations during this 10-year period. Between fiscal
years 1999 and 2008, user fee funding increased 268 percent from about
$120 million to about $443 million, while fiscal year appropriations
increased 69 percent from about $441 million to about $746 million.
Over three-quarters of the increase in user fee funding over this
period supported the drugs program, with the remaining portion
supporting the biologics and devices programs. Appendix I provides
additional information on funding and staffing resources for FDA's
medical product programs.
Figure 2: Annual Medical Product Program Funding from Fiscal Year
Appropriations and User Fees, Fiscal Years 1999 through 2008:
[Refer to PDF for image: stacked line graph]
Fiscal year: 1999;
Fiscal year appropriations: $441.2 million;
User fees: $120.4 million;
Total: $561.2 million.
Fiscal year: 2000;
Fiscal year appropriations: $479.3 million;
User fees: $142.9 million;
Total: $622.2 million.
Fiscal year: 2001;
Fiscal year appropriations: $492.1 million;
User fees: $155.2 million;
Total: $647.3 million.
Fiscal year: 2002;
Fiscal year appropriations: $573.3 million;
User fees: $162.6 million;
Total: $735.9 million.
Fiscal year: 2003;
Fiscal year appropriations: $612.7 million;
User fees: $201.8 million;
Total: $814.5 million.
Fiscal year: 2004;
Fiscal year appropriations: $605.6 million;
User fees: $242.5 million;
Total: $848.1 million.
Fiscal year: 2005;
Fiscal year appropriations: $629.6 million;
User fees: $267.5
Total: $897.1 million.
Fiscal year: 2006;
Fiscal year appropriations: $656.8 million;
User fees: $304.9 million;
Total: $961.7 million.
Fiscal year: 2007;
Fiscal year appropriations: $692.1 million;
User fees: $340.1 million;
Total: $1.0 billion.
Fiscal year: 2008;
Fiscal year appropriations: $746.5 million;
User fees: $443.2 million;
Total: $1.2 billion.
Source: GAO analysis of FDA data.
[End of figure]
Between fiscal years 1999 and 2008, total funding for FDA's medical
product programs--including fiscal year appropriations and user fee
funding--grew 112 percent. This rate of growth was higher than the
rates of growth in total funding for the rest of FDA (86 percent), as
well as total funding for HHS (98 percent) and the federal government
(87 percent).[Footnote 41] The high rate of growth in total funding for
FDA's medical product programs was due to large increases in FDA's user
fee funding. Fiscal year appropriations for FDA's medical product
programs grew at a slower rate than fiscal year appropriations for
other FDA programs between fiscal years 1999 and 2008, as shown in
table 1. Fiscal year appropriations for FDA's medical product programs
also grew at a slower rate (69 percent) than discretionary funding for
HHS (74 percent) and the federal government (103 percent).
Table 1: Percentage Increase in Fiscal Year Appropriations, User Fee
Funding, and Total Funding for FDA, Fiscal Years 1999 through 2008:
Medical product programs;
Percentage increase in Fiscal year appropriations: 69;
Percentage increase in User fee funding: 268;
Percentage increase in Total funding: 112.
Drugs program;
Percentage increase in Fiscal year appropriations: 77;
Percentage increase in User fee funding: 320;
Percentage increase in Total funding: 145.
Biologics program;
Percentage increase in Fiscal year appropriations: 63;
Percentage increase in User fee funding: 168;
Percentage increase in Total funding: 88.
Devices program;
Percentage increase in Fiscal year appropriations: 63;
Percentage increase in User fee funding: 184;
Percentage increase in Total funding: 73.
Other programs;
Percentage increase in Fiscal year appropriations: 79;
Percentage increase in User fee funding: 234;
Percentage increase in Total funding: 86.
FDA Total;
Percentage increase in Fiscal year appropriations: 75;
Percentage increase in User fee funding: 262;
Percentage increase in Total funding: 99.
Source: GAO analysis of FDA data.
[End of table]
PDUFA and MDUFMA require the agency to apply all user fee funding, as
well as a specified amount of fiscal year appropriations, to support
user fee activities that are related to the agency's process for
reviewing applications for new drugs, new biologics, and certain new
devices. Taking this requirement into account, we found that total
funding for the medical product programs' user fee activities increased
eight times faster than funding for the programs' other activities
between fiscal years 1999 and 2008.[Footnote 42] Specifically, funding
for user fee activities increased 207 percent over the 10-year period
while total funding for the programs' other activities increased 25
percent--the same rate as inflation over this period as measured by the
GDP price index.[Footnote 43]
As funding for user fee activities grew faster between fiscal year 1999
and 2008 than funding for other program activities not funded with user
fees, a declining share of fiscal year appropriations was available to
other program activities. In fiscal year 1999, the medical product
programs allocated 48 percent of their total $562 million funding--
including 33 percent of their fiscal year appropriations--to user fee
activities. In fiscal year 2008, these programs allocated 69 percent of
their total $1.2 billion funding--including 51 percent of their fiscal
year appropriations--to user fee activities. In fiscal year 2008, the
medical product programs allocated 31 percent of their total funding to
other program activities not funded by user fees. (See figure 3.)
Figure 3: Portion of Total Medical Product Program Funding Allocated to
User Fee Activities and Other Program Activities, Fiscal Years 1999 and
2008:
[Refer to PDF for image: two pie-charts]
Fiscal year 1999:
User fee activities: 48%;
Other activities: 52%.
Fiscal year 2008:
User fee activities: 69%;
Other activities: 31%.
Funding for user fee activities and other activities:
User fee activities:
Fiscal year 1999: $267.1 million;
Fiscal year 2008: $820.4 million.
Other agency activities not funded with user fees:
Fiscal year 1999: $294.6 million;
Fiscal year 2008: $369.4 million.
Total:
Fiscal year 1999: $561.7 million.
Fiscal year 2008: $1.2 billion.
Source: GAO analysis of FDA data.
Note: In fiscal year 1999, FDA's user fee activities were related to
the agency's premarket review of drugs and biologics, as well as
inspections of certain mammography facilities. In fiscal year 2008,
FDA's user fee activities also included the agency's premarket review
of certain devices, postmarket activities for certain devices, and some
postmarket activities for drugs. Other activities not funded with user
fees included all other program activities, such as the agency's
oversight of the safety of transfusion-related blood products and human
tissues; review of applications for generic and over-the-counter drugs;
inspections unrelated to an application for a new product; oversight of
advertising and promotional activities for marketed products;
activities related to the oversight of the safety of marketed biologics
and devices; as well as agency research and policy development
unrelated to the review of new medical products.
[End of figure]
Although total funding increased, FDA officials reported that the
decline in the portion of funding available to activities not funded by
user fees has seriously limited the agency's ability to fulfill its
oversight responsibilities in some areas.[Footnote 44] FDA officials
noted a disproportionate growth in funding available for the agency's
user fee activities compared with other agency activities not funded
with user fees, such as the agency's oversight of transfusion-related
blood products, human tissues, device compliance and enforcement, and
radiological health, as well as its work in reviewing ANDAs, examining
drug-related advertising materials, and conducting inspections of
establishments manufacturing approved drugs.
To supplement our analysis of trends in FDA resources from fiscal years
1999 through 2008, we analyzed how FDA's medical product programs
allocated funding to center and field activities from fiscal years 2004
through 2008. We found that each of the medical product programs
allocated most of their annual funding to activities conducted by the
centers (CDER, CBER, and CDRH). The programs also provided some funding
for field activities conducted by ORA. We found that funding for the
medical product programs' center activities grew three times as fast as
funding for the programs' field activities. We also noted that funding
for field activities increased at about the same rate as the GDP
inflation rate. (See appendix II for additional information on trends
in center and field funding and staffing resources for the medical
product programs.)
Medical Product Program Staffing Resources Have Increased, but FDA Is
Concerned about Hiring and Attrition:
Staffing resources for FDA's medical product programs increased between
fiscal year 1999 and fiscal year 2008. The number of FTEs[Footnote 45]
supporting FDA's medical product programs increased 14 percent from
4,925 FTEs in fiscal year 1999 to 5,626 FTEs in fiscal year
2008.[Footnote 46] This increase was due solely to a growth in the
number of FTEs funded by user fees--the number of FTEs funded by fiscal
year appropriations declined. Specifically, the number of medical
product program FTEs funded by user fees increased 113 percent--from
856 FTEs in fiscal year 1999 to 1,825 FTEs in fiscal year 2008--while
FTEs funded by fiscal year appropriations declined 7 percent, or from
4,069 FTEs in fiscal year 1999 to 3,802 FTEs in fiscal year 2008. FDA
officials told us that they had to actively reduce the number of staff
by offering buyouts to employees to leave the agency between fiscal
years 2004 and 2006 because the agency did not receive enough fiscal
year appropriations in these years to maintain staffing levels.
According to FDA officials, FTE costs--salary and benefit costs--grew
at a faster rate than fiscal year appropriations during this period.
Figure 4 displays the number of FTEs from fiscal year appropriations
and user fees for each year, fiscal years 1999 through 2008.
Figure 4: Annual Medical Product Program Staffing Resources from Fiscal
Year Appropriations and User Fees, Fiscal Years 1999 through 2008:
[Refer to PDF for image: stacked line graph]
Fiscal year: 1999;
Fiscal year appropriations: 4,069;
User fees: 856;
Total: 4,925.
Fiscal year: 2000;
Fiscal year appropriations: 4,044;
User fees: 928;
Total: 4,972.
Fiscal year: 2001;
Fiscal year appropriations: 4,038;
User fees: 1,011;
Total: 5,049.
Fiscal year: 2002;
Fiscal year appropriations: 4,118;
User fees: 989;
Total: 5,107.
Fiscal year: 2003;
Fiscal year appropriations: 4,299;
User fees: 1,111;
Total: 5,410.
Fiscal year: 2004;
Fiscal year appropriations: 4,111;
User fees: 1,391;
Total: 5,502.
Fiscal year: 2005;
Fiscal year appropriations: 3,972;
User fees: 1,503;
Total: 5,475.
Fiscal year: 2006;
Fiscal year appropriations: 3,859;
User fees: 1,565;
Total: 5,424.
Fiscal year: 2007;
Fiscal year appropriations: 3,893;
User fees: 1,611;
Total: 5,504.
Fiscal year: 2008;
Fiscal year appropriations: 3,802;
User fees: 1,825;
Total: 5,627.
Source: GAo analysis of FDA data.
Note: FTEs do not include contractors and therefore provide a partial
measure of total staffing resources.
[End of figure]
While our analysis of FDA data shows that the number of medical product
program FTEs increased between fiscal year 1999 and 2008, FTEs do not
include contractors and therefore provide a partial measure of total
staffing resources. FDA could not provide data showing the total number
of contractors it used or the total amount of funding it spent on
contractors to support its medical product programs over this period.
As a result, we could not fully assess the medical product programs'
staffing resources. FDA officials estimated that the agency used an
increasing number of contractors to fulfill its medical product
responsibilities between fiscal years 1999 and 2008.[Footnote 47]
However, agency officials were unable to provide us with data to
corroborate this estimate.[Footnote 48]
According to FDA officials, the decline in the number of FTEs funded by
FDA's fiscal year appropriations limited the agency's ability to
fulfill its medical product oversight responsibilities. FDA officials
noted that they do not have enough staff to adequately perform duties
that do not receive user fee funding, such as the agency's review of
ANDAs, oversight of product advertising and promotion, and inspections
of establishments manufacturing marketed products. As a result, FDA
officials noted that the agency's work in these areas is increasingly
backlogged.
In addition to their concerns about the adequacy of the agency's fiscal
year appropriations, FDA officials are also concerned about the
agency's ability to hire staff, particularly those in certain
scientific occupations. For example, FDA officials noted that the
agency is facing challenges hiring biologists, chemists, computer
programmers, consumer safety officers, engineers, epidemiologists,
mathematical statisticians, medical officers, and pharmacologists,
among other occupations. FDA officials noted that the lack of
sufficient numbers of staff and extended vacancies in specific
occupations resulted in higher workloads and longer hours for current
staff, as well as postponed or reduced work in some areas.
FDA officials also noted concerns about the agency's ability to retain
staff, particularly those in certain scientific occupations. FDA
officials said that a high percentage of staff from the medical product
centers and ORA leave their positions--including those who move within
FDA, leave the agency, and retire. Specifically, FDA data show that
between 2000 and 2007, the average annual percent of staff who left
their positions at CDER, CBER, and CDRH ranged from 11 to 13 percent,
and at ORA headquarters and regional offices ranged from 6 to 23
percent. However, a portion of these staff stayed within FDA and HHS.
FDA officials told us that the loss of any staff from their centers
presents challenges as it takes time for the centers to hire and train
new staff. For example, FDA officials noted that it takes about 2 years
to effectively train new staff who review applications for new medical
products.
FDA Faced Challenges Fulfilling and Managing Its Growing Medical
Product Oversight Responsibilities, Citing Resource Constraints:
New laws and a growing workload increased FDA's medical product
oversight responsibilities. FDA did not fulfill its oversight
responsibilities between fiscal years 2004 and 2008 in some areas,
which agency officials attributed to resource constraints.
FDA's Medical Product Oversight Responsibilities Expanded Due to the
Enactment of New Laws:
Laws enacted since 1999 added new requirements that expanded FDA's
medical product oversight responsibilities. On the basis of our review,
we found 11 laws that specifically added to FDA's medical product
oversight responsibilities. These 11 laws were enacted between 2002 and
2007.[Footnote 49] (See figure 5.)
Figure 5: Timeline of 11 Laws Enacted between 2002 and 2007 That
Increased FDA's Medical Product Oversight Responsibilities:
[Refer to PDF for image: illustration]
2002:
Medical Device User Fee and Modernization Act of 2002;
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002;
Best Pharmaceuticals for Children Act.
2003:
Medicare Prescription Drug, Improvement, and Modernization Act of 2003;
Pediatric Research Equity Act of 2003.
2004:
Mammography Quality Standards Reauthorization Act of 2004;
Project BioShield Act of 2004;
Medical Devices Technical Corrections Act.
2005:
Medical Device User Fee Stablization Act of 2005.
2006:
Dietary Supplement and Nonprescription Drug Consumer Protection Act.
2007:
Food and Drug Administration Amendments Act of 2007.
Source: GAO analysis of FDA documents and CRS reports.
[End of figure]
These 11 laws added many additional requirements and authorities to
FDA, increasing the agency's oversight responsibilities ranging from
premarket review of medical products to the agency's oversight of the
safety of marketed medical products. These additional oversight
responsibilities included an expansion in FDA's authority to regulate
devices, an increase in the amount of information that the agency needs
to review before deciding whether to approve new drugs and biologics,
and greater authority to monitor the safety of approved products. To
implement these new requirements and authorities, FDA, for example,
needed to issue new guidance for industry and new operating procedures
for staff, and established new committees that the agency needed to
consult with to fulfill its oversight responsibilities.
One of the many new oversight responsibilities that FDA was charged
with was added by MDUFMA.[Footnote 50] In 2002, MDUFMA instituted a
regulatory oversight function for reprocessed single-use devices.
[Footnote 51] MDUFMA required manufacturers of certain devices to
submit additional information to the agency validating that reprocessed
single-use devices are substantially equivalent to current or
previously marketed single-use devices. The law also created a new
application for the approval of reprocessed high-risk devices. As a
result of these new authorities, FDA created new guidance documents and
conducted presentations with industry and healthcare professionals
related to the agency's oversight of these products. According to
agency officials, the implementation of this expanded authority
resulted in a significant increase in FDA's workload, particularly in
2002 when FDA officials estimated that about 17 FTEs were dedicated to
implementing this authority and developing guidance documents.
Another law, the Pediatric Research Equity Act of 2003 (PREA),
increased the amount of information that FDA must review to approve a
new drug or new biologic.[Footnote 52] FDA became responsible for
reviewing more materials to assess the products' safety and
effectiveness for children, including appropriate information to
include on product labeling. Specifically, PREA required sponsors to
submit a pediatric assessment containing additional information about
the pediatric use of a drug or biologic at the time they submit an
application or supplement. As a result of the reviews of these required
pediatric assessments, FDA issued 86 PREA-related labeling changes for
drugs and biologics between December 2003 and December 2008.
A more recent example of a law increasing FDA's medical product
responsibilities is the Food and Drug Administration Amendments Act of
2007 (FDAAA).[Footnote 53] FDAAA increased FDA's postmarket oversight
responsibilities for medical products by giving FDA authority to
require sponsors to conduct studies or clinical trials for approved
drugs in cases where FDA has identified new safety concerns.[Footnote
54] To require such a study, FDA officials said that they document
their rationale in a legally enforceable contract with a sponsor. These
contracts may outline specific elements of the study design. FDA
officials stated that the process of developing such contracts results
in additional work for the agency. From the enactment of FDAAA in
September 2007 through January 2009, FDA required drug sponsors to
conduct 45 postmarket studies for NDAs and biologics sponsors to
conduct 15 postmarket studies for BLAs, for drugs and biologics
approved before and after the implementation of FDAAA.
FDA Faced a Growing Workload:
FDA also faced a growing workload and was responsible for overseeing
increasing numbers of marketed products and establishments. FDA's
medical product workload grew between fiscal years 1999 and 2008 in
part due to the receipt of an increasing number of applications and
application supplements. The number of drug, biologic, and device
application materials submitted to FDA grew 30 percent over this
period, from 23,079 in fiscal year 1999 to 30,060 in fiscal year 2008.
In particular, the number of application supplements grew 48 percent
(from 13,694 application supplements in fiscal year 1999 to 20,329
application supplements in fiscal year 2008). The number of medical
product applications also increased during this time period by 8
percent, or from 8,313 applications to 8,943 applications. At the same
time, the number of applications resubmitted for medical product
approval decreased 26 percent from 1,072 to 788 (see figure 6).
Figure 6: Trends in Medical Product Applications, Resubmitted
Applications, and Application Supplements Submitted to FDA, Fiscal
Years 1999 through 2008:
[Refer to PDF for image: two stacked line graphs]
Applications, resubmitted applications and supplements:
Fiscal year: 1999;
Devices: 12,132;
Biologics: 2,567;
Drugs: 8,380.
Fiscal year: 2000;
Devices: 12,016;
Biologics: 3,193;
Drugs: 8,110.
Fiscal year: 2001;
Devices: 12,462;
Biologics: 3,059;
Drugs: 8,491.
Fiscal year: 2002;
Devices: 12,824;
Biologics: 2,939;
Drugs: 9,539.
Fiscal year: 2003;
Devices: 13,978;
Biologics: 3,218;
Drugs: 9,555.
Fiscal year: 2004;
Devices: 12,261;
Biologics: 2,801;
Drugs: 11,251.
Fiscal year: 2005;
Devices: 12,668;
Biologics: 2,222;
Drugs: 10,960.
Fiscal year: 2006;
Devices: 13,920;
Biologics: 2,298;
Drugs: 11,326.
Fiscal year: 2007;
Devices: 14,026;
Biologics: 2,393;
Drugs: 12,495.
Fiscal year: 2008;
Devices: 14,958;
Biologics: 2,572;
Drugs: 12,530.
[End of figure]
Applications, resubmitted applications and supplements:
Fiscal year: 1999;
Resubmitted applications: 1,072;
Supplements: 13,694;
Applications: 8,313.
Fiscal year: 2000;
Resubmitted applications: 936;
Supplements: 14,093;
Applications: 8,290.
Fiscal year: 2001;
Resubmitted applications: 970;
Supplements: 14,805;
Applications: 8,237.
Fiscal year: 2002;
Resubmitted applications: 1,015;
Supplements: 15,422;
Applications: 8,865.
Fiscal year: 2003;
Resubmitted applications: 805;
Supplements: 15,899;
Applications: 10,047.
Fiscal year: 2004;
Resubmitted applications: 698;
Supplements: 17,200;
Applications: 8,415.
Fiscal year: 2005;
Resubmitted applications: 571;
Supplements: 16,599;
Applications: 8,680.
Fiscal year: 2006;
Resubmitted applications: 567;
Supplements: 18,020;
Applications: 8,957.
Fiscal year: 2007;
Resubmitted applications: 664;
Supplements: 18,696;
Applications: 9,554.
Fiscal year: 2008;
Resubmitted applications: 788;
Supplements: 20,329;
Applications: 8,943.
Source: GAO analysis of FDA data.
Note: In fiscal year 2004, FDA transferred oversight responsibilities
for certain biological products from the biologics program to the drugs
program.
[End of figure]
In addition to receiving an increasing number of applications and
application supplements, FDA's workload also grew due to an increase in
other demands placed on the agency. For example, FDA received 797,889
more reports of adverse events related to medical products in fiscal
year 2008 than in fiscal year 1999, an increase of 228 percent. FDA
also received 40,193 more drug-and biologic-related advertising and
promotional materials to examine (an increase of 115 percent),[Footnote
55] and 885 more meeting requests from sponsors regarding drug and
biologic products in development during this time period (an increase
of 56 percent).[Footnote 56]
The complexity of products subject to FDA oversight has also grown,
thus increasing the agency's workload. FDA officials, as well as FDA's
Science Board, reported that rapid advances in science and technology,
including the fields of genomics and nanotechnology, have increased the
complexity of the medical products submitted to FDA for premarket
approval. FDA officials told us that the agency seeks and provides
training for its reviewers so they can more effectively review the
safety and effectiveness of these increasingly complex products.
However, agency officials said that this training results in less time
available for staff to perform their routine duties. In addition, FDA
officials also increasingly seek the advice of scientific experts from
outside the agency, including advisory committee members, to assist in
the review of applications for new drugs and new biologics. Similarly,
seeking the advice of experts requires additional staff time to obtain
and weigh these perspectives.
In addition to facing a growing workload, the total number of medical
products and establishments FDA oversees also increased between fiscal
years 1999 and 2008. FDA is responsible for monitoring the safety of
marketed medical products, and as the number of these products and
manufacturing establishments has grown, so have the agency's oversight
responsibilities. The number of medical products approved or cleared
for marketing has grown 55 percent, or by 41,203 medical products,
during this time period. In addition, the total number of
establishments registered to produce medical products marketed for sale
in the United States--a proxy for the number of establishments subject
to FDA oversight and inspection--grew over this time period, due to
increases in the number of foreign establishments. However, from fiscal
years 1999 to 2008, FDA saw a decrease--2 percent or 311
establishments--in the number of domestic establishments registered to
produce medical products.[Footnote 57] Over the same time period, the
number of foreign establishments registered to produce medical products
increased by 23 percent or 1,921 establishments. See table 2 for trends
in domestic and foreign establishments registered to produce medical
products.
Table 2: Number of Domestic and Foreign Establishments Registered to
Produce Medical Products for the U.S. Market, Fiscal Years 1999 and
2008:
Domestic establishments:
Drugs;
Fiscal year: 1999: 3,715;
Fiscal year: 2008: 5,074.
Biologics;
Fiscal year: 1999: 1,601;
Fiscal year: 2008: 2,571.
Devices;
Fiscal year: 1999: 10,179;
Fiscal year: 2008: 7,539.
Total domestic establishments;
Fiscal year: 1999: 15,495;
Fiscal year: 2008: 15,184.
Foreign establishments:
Drugs;
Fiscal year: 1999: 857;
Fiscal year: 2008: 3,035.
Biologics;
Fiscal year: 1999: 7;
Fiscal year: 2008: 57.
Devices;
Fiscal year: 1999: 7,399;
Fiscal year: 2008: 7,092.
Total foreign establishments;
Fiscal year: 1999: 8,263;
Fiscal year: 2008: 10,184.
Total domestic and foreign establishments;
Fiscal year: 1999: 23,731;
Fiscal year: 2008: 25,368.
Source: GAO analysis of FDA data.
Notes: In prior reports we found that FDA's establishment registration
databases contain inaccurate information on the number of
establishments manufacturing drugs and devices. However, these data
represent the best information available and are what FDA relies on to
manage its inspection activities. In fiscal year 2004, FDA transferred
oversight responsibilities for certain biological products from CBER to
CDER. The number of establishments registered to produce biologics and
drugs reflects agency oversight responsibilities in fiscal years 1999
and 2008.
[End of table]
FDA Officials Cited Resource Constraints as Hindering the Agency's
Ability to Fulfill Its Oversight Responsibilities in Some Areas between
Fiscal Years 2004 and 2008:
FDA officials told us that resource constraints hindered the agency's
ability to fulfill all of its medical product oversight
responsibilities between fiscal years 2004 and 2008, but the agency
also lacked information to manage some of these oversight
responsibilities and estimate current and future resource needs. For
the two key areas we reviewed where statutory requirements and
performance goals set expectations for the agency's work during this
period--review of applications for generic drugs, new drugs, and new
biologics, and medical product inspections--FDA did not meet all of its
medical product oversight responsibilities. In the other two key areas
we reviewed--examination of advertising and promotional materials and
review of adverse event reports--we found that while FDA faced an
increasing workload, it could not always provide data on the work it
performed to fulfill these responsibilities.
FDA did not meet all of its medical product oversight responsibilities
where requirements and performance goals set expectations for the
agency's work from fiscal years 2004 through 2008. For example, FDA did
not meet the requirement to complete its first review of ANDAs within
180 days of receipt during this period. We found that the percent of
ANDAs that FDA reviewed within this 180 day requirement declined from
87 percent in fiscal year 2004 to 32 percent in fiscal year
2008.[Footnote 58] FDA received an increasing number of ANDAs during
this time period, and agency officials explained that they were unable
to review all applications submitted within the 180 day requirement
because they did not have sufficient resources to conduct these
reviews. As a result, an increasing number of ANDAs were pending
review, creating a backlog.[Footnote 59]
While FDA met most of its PDUFA performance goals related to the speed
at which it reviewed NDAs and BLAs and related application supplements,
the agency did not meet most PDUFA performance goals related to the
speed at which it scheduled and held meetings with sponsors and
responded to sponsor requests for information between fiscal years 2004
and 2008. FDA officials explained that they were unable to meet all of
these performance goals due to inadequate resources. FDA officials
explained that they placed a higher priority on reviewing applications
and therefore had fewer resources to schedule and hold meetings or
respond to sponsors' requests for information.
FDA also did not meet all of its inspection requirements and requested
additional funding to begin conducting more inspections. FDA did not
conduct inspections every 2 years as required for two of three types of
establishments we reviewed. FDA officials estimated that the agency, on
average, conducts inspections of domestic drug manufacturers every 3
years, domestic device manufacturers every 3 or 5 years, and domestic
blood banks every 2 years. FDA officials estimated that the agency
conducts inspections less frequently for other types of establishments
that do not have required time frames for the frequency of inspections-
-domestic human tissue banks, foreign drug manufacturers, and foreign
device manufacturers. (See table 3.) In fiscal year 2008, FDA requested
and received additional funding to strengthen field operations and
conduct more domestic and foreign inspections of medical product
establishments.
Table 3: FDA's Estimated Frequency of Inspections for Selected
Establishment Types:
Establishment type: Establishment types with a biennial inspection
requirement: Domestic drug manufacturing[A];
Frequency of inspection: 3 years.
Establishment type: Establishment types with a biennial inspection
requirement: Domestic blood banks;
Frequency of inspection: 2 years.
Establishment type: Establishment types with a biennial inspection
requirement: Domestic device manufacturing[B];
Frequency of inspection: Class III (high-risk) devices: 3 years;
Class II (medium-risk) devices: 5 years.
Establishment type: Establishment types without a requirement for
inspection frequency: Foreign drug manufacturing[A];
Frequency of inspection: 12 years.
Establishment type: Establishment types without a requirement for
inspection frequency: Domestic human tissue banks;
Frequency of inspection: 4-5 years.
Establishment type: Establishment types without a requirement for
inspection frequency: Foreign device manufacturing[B];
Frequency of inspection: Class III (high-risk) devices: 6 years;
Class II (medium-risk) devices: 27 years.
Source: FDA.
Notes: We provide FDA's estimated inspection frequency because FDA does
not know how many establishments are subject to inspection and
therefore the percentage of those inspected cannot always be calculated
with certainty.
[A] FDA primarily conducts inspections of establishments manufacturing
prescription drugs, as opposed to over-the-counter drugs, because FDA
generally considers establishments manufacturing over-the-counter drugs
to have a lower inspection priority.
[B] FDA classifies devices into one of three categories: class III
(high-risk) devices include devices such as heart valves, pacemakers,
and defibrillators; class II (medium-risk) devices include mercury
thermometers, hearing aids, and electrocardiograph machines; and class
I (low-risk) devices include tongue depressors, elastic bandages, and
bedpans. There is no requirement for the frequency of FDA inspection of
manufacturers of class I devices and FDA does not routinely inspect
them. See 21 U.S.C. §§ 360(h), 360c.
[End of table]
FDA faced an increasing workload in the other two areas we reviewed--
review of adverse event reports and examination of advertising and
promotional materials. Agency officials said they lacked sufficient
resources in these areas. Similar to what we reported in 1989, we found
that FDA lacks information to manage these responsibilities and
estimate current and future resource needs. Although adverse event
monitoring is a key mechanism for FDA to identify postmarket safety
risks related to the use of marketed medical products, agency officials
told us that they receive substantially more drug-, biologic-, and
device-related adverse event reports than staff can review. Between
fiscal years 2004 and 2008, FDA received an increasing number of
adverse event reports for medical products, from 635,035 reports in
fiscal year 2004 to 1,147,442 reports in fiscal year 2008. However, FDA
officials could not provide data showing how many adverse event reports
staff review. FDA officials told us that they place the highest
priority on reviewing reports of serious adverse events, such as those
involving death or severe injury, and unexpected adverse events--those
not noted on approved product labeling. Yet, FDA officials were unable
to provide data to corroborate their reviews of these reports of
serious and unexpected events. In addition, while FDA receives
relatively few promotional materials for biologics and devices, the
agency receives substantially more drug-related promotional materials
than staff can review, according to agency officials. Between fiscal
years 2004 and 2008, FDA received a steadily increasing number of final
promotional materials--from 45,394 in fiscal year 2004 to 70,509 in
fiscal year 2008. Again, FDA could not provide data showing how many
drug-related advertising and promotional materials staff review.
Although FDA officials told us that they place a high priority on
reviewing materials that have the greatest potential to affect public
health, they were unable to provide data to corroborate their reviews
of these materials. FDA officials have told us that collecting data on
the work staff performed would be time-consuming and detract from
resources needed to devote to conducting these reviews.[Footnote 60]
While FDA officials noted the agency's inability to fulfill all of its
responsibilities due to resource constraints, FDA does not have the
data to develop a complete and reliable estimate of the resources it
needs to conduct all of its responsibilities. Specifically, we found
that FDA lacked information about its current resources, workload, and
performance in some areas, such as with the review of adverse event
reports and promotional materials. This basic management information is
critical to the development of a complete and reliable resource
estimate. FDA officials also told us that the funding amounts requested
for FDA and provided by Congress during the past 2 years will permit
the agency to respond to its most urgent needs and priorities, although
officials also noted that they did not receive enough resources to meet
some statutory requirements. For example, agency officials noted that
they were unable to inspect certain manufacturing establishments at
prescribed intervals due to resource constraints. Furthermore, FDA
officials also noted that the agency continues to face significant
challenges fulfilling its mission.
For more information on the trends in FDA's workload and resources for
the four key areas that we reviewed, see appendix III for FDA's review
of generic drug, new drug, and new biologic applications, appendix IV
for inspections of medical product research activities and
manufacturing establishments, appendix V for the review of adverse
event reports, and appendix VI for the examination of advertising and
promotional materials.
Conclusions:
The growth in the complexity and number of new medical products and the
establishments manufacturing them, increasing globalization, and added
statutory requirements and responsibilities have translated into
mounting and competing demands for FDA's resources. Concerns regarding
the adequacy of these resources are not new, but as demands on the
agency have soared in recent years, these concerns have intensified.
Earlier this year, we included FDA's oversight of medical products in
our High-Risk Series. Our current examination of FDA's resources
confirms that the agency's ability to protect Americans from unsafe and
ineffective medical products is compromised. The structure of the
agency's funding--its reliance on user fees to fund certain activities,
particularly those related to the review of new products--is a driving
force behind which responsibilities FDA does and does not fulfill. The
approval of new products has increasingly become the beneficiary of the
agency's budget, without parallel increases in funding for activities
designed to ensure the continuing safety of products, once they are on
the market. The enactment of FDAAA in 2007 gave FDA the ability to
apply user fee funding to more postmarket activities for some types of
medical products, providing the agency more flexibility in its use of
funding.
FDA reports that it cannot do all that is asked of it and our analysis
of the agency's activities confirms this. However, as FDA officials
told us, the agency's requests for resources do not reflect all the
resources it needs to fulfill its mission, including meeting its
statutory requirements. FDA could not provide data showing its workload
and accomplishments in some areas. Furthermore, it lacks other basic
management information, such as the size of its contractor workforce.
Without this information, FDA does not have data to reliably estimate
its resource needs--a problem we reported 20 years ago and which served
as the basis of our recommendation that FDA collect such data. Since
then we have made similar recommendations that the agency improve its
management and tracking of its resources and workload. FDA has
disagreed with these recommendations, claiming that it lacks the
resources to devote to this data collection and that it would detract
from its oversight responsibilities. We acknowledge that FDA is facing
significant challenges in fulfilling its responsibilities, but continue
to believe that developing such information is an essential component
of ultimately enhancing the agency's ability to adequately fulfill its
mission. Without such basic data needed for managing its programs, FDA
cannot develop sound and justifiable budget requests that reflect all
the work that is vital to fulfilling its mission, including meeting its
performance goals and its statutory requirements. It is also difficult
for others to independently verify the extent to which FDA receives
sufficient resources and whether the agency is appropriately utilizing
and prioritizing the resources it receives.
Recommendations for Executive Action:
We recommend that the Commissioner of FDA establish a comprehensive and
reliable basis to substantiate the agency's estimates of its current
and future resource needs in a manner consistent with the principles
contained in our cost estimating and assessment guide. To do so, we
recommend that the Commissioner of FDA take the following four actions:
1. Conduct a comprehensive assessment of the agency's staffing
resources, including its contractor workforce.
2. Gather data on the work the agency conducts to fulfill its
responsibilities.
3. Assess the extent to which the agency is meeting its
responsibilities.
4. Develop an evidence-based estimate of the resources needed to
fulfill all of its responsibilities.
Agency Comments:
We provided a draft of this report to HHS for review. HHS provided
comments from FDA. In its comments, FDA agreed with our four
recommendations and described the steps it would take to implement
them. FDA's comments are reprinted in appendix VII. FDA also provided
technical comments, which we incorporated as appropriate.
In its comments, FDA acknowledged that we identified some important
issues regarding the challenges the agency faces in meeting its medical
product responsibilities. It highlighted the President's requested
increase in the agency's medical product program funding for fiscal
year 2010, which it said would support a life-cycle approach to safety,
provide for increased inspections, and support the implementation of
requirements included in FDAAA. Specifically, regarding our
recommendations, FDA said that a comprehensive assessment of its
staffing resources would provide useful information and that it will
expand its current staffing assessment process to include its
contractor workforce. The agency also said it will conduct a complete
inventory of all regulatory work products by FDA center and that it
would identify and implement measures to determine how effectively the
agency is meeting its responsibilities. Finally, FDA said that it plans
to link these measures to its budget and funding allocation. FDA said
that this approach will inform the agency about how well it is
allocating its resources and help identify what additional resources it
needs to fulfill its responsibilities. We believe that the agency's
completion of the activities described, as well as other necessary and
related actions to implement our recommendations, should assist FDA in
developing a comprehensive and reliable basis for substantiating the
agency's resource needs and help it better manage its medical product
programs.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies to the
Commissioner of FDA and appropriate congressional committees. The
report also will be available at no charge on the GAO Web site at
[hyperlink, http://www.gao.gov].
If you or your staff have any questions about this report, please
contact me at (202) 512-7114 or crossem@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made major contributions to
this report are listed in appendix VIII.
Signed by:
Marcia Crosse:
Director, Health Care:
List of Requesters:
The Honorable Edward M. Kennedy:
Chairman:
Committee on Health, Education, Labor, and Pensions:
United States Senate:
The Honorable Charles E. Grassley:
Ranking Member:
Committee on Finance:
United States Senate:
The Honorable Henry A. Waxman:
Chairman:
The Honorable John D. Dingell:
Chairman Emeritus:
The Honorable Joe Barton:
Ranking Member:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Bart Stupak:
Chairman:
The Honorable Greg Walden:
Ranking Member:
Subcommittee on Oversight and Investigations:
Committee on Energy and Commerce:
House of Representatives:
[End of section]
Appendix I: Funding and Staffing Resources for FDA Medical Product
Programs, Fiscal Years 1999 through 2008:
Funding resources for the Food and Drug Administration's (FDA) medical
product programs increased 112 percent between fiscal years 1999 and
2008. Of the medical product programs:
* drugs program funding increased 145 percent, from $278.3 million in
fiscal year 1999 to $680.9 million in fiscal year 2008;
* biologics program funding increased 88 percent, from $124.4 million
in fiscal year 1999 to $233.5 million in fiscal year 2008; and:
* devices program funding increased 73 percent, from $159.0 million in
fiscal year 1999 to $275.3 million in fiscal year 2008.
Table 4 displays funding resources for FDA programs for fiscal years
1999 through 2008.
Table 4: Funding Resources for FDA Programs, Fiscal Years 1999 through
2008 (Dollars in millions):
Drugs program:
1999: $278.3;
2000: $311.2;
2001: $322.5;
2002: $364.3;
2003: $403.8;
2004: $459.6;
2005: $482.1;
2006: $508.9;
2007: $543.6;
2008: $680.9.
Drugs program: Fiscal year appropriations;
1999: $200.4;
2000: $215.5;
2001: $218.5;
2002: $254.7;
2003: $274.1;
2004: $292.1;
2005: $291.5;
2006: $297.7;
2007: $315.1;
2008: $353.9.
Drugs program: User fees;
1999: $77.9;
2000: $95.7;
2001: $104.0;
2002: $109.6;
2003: $129.8;
2004: $167.5;
2005: $190.7;
2006: $211.2;
2007: $228.4;
2008: $327.0.
Biologics program[A]:
1999: $124.4;
2000: $140.7;
2001: $147.2;
2002: $177.8;
2003: $193.4;
2004: $167.0;
2005: $170.7;
2006: $197.7;
2007: $202.2;
2008: $233.5.
Biologics program[A]: Fiscal year appropriations;
1999: $95.0;
2000: $106.1;
2001: $108.3;
2002: $138.6;
2003: $145.3;
2004: $122.4;
2005: $123.1;
2006: $138.5;
2007: $146.3;
2008: $154.8.
Biologics program[A]: User fees;
1999: $29.3;
2000: $34.6;
2001: $38.9;
2002: $39.2;
2003: $48.1;
2004: $44.7;
2005: $47.6;
2006: $59.2;
2007: $55.8;
2008: $78.7.
Devices program:
1999: $159.0;
2000: $170.3;
2001: $177.6;
2002: $193.7;
2003: $217.3;
2004: $221.5;
2005: $244.3;
2006: $255.0;
2007: $267.5;
2008: $275.3.
Devices program: Fiscal year appropriations;
1999: $145.8;
2000: $157.7;
2001: $165.3;
2002: $180.0;
2003: $193.4;
2004: $191.1;
2005: $215.0;
2006: $220.6;
2007: $230.7;
2008: $237.7.
Devices program: User fees;
1999: $13.2;
2000: $12.6;
2001: $12.3;
2002: $13.7;
2003: $23.9;
2004: $30.4;
2005: $29.3;
2006: $34.5;
2007: $36.9;
2008: $37.6.
Medical product programs[B]:
1999: $561.7;
2000: $622.2;
2001: $647.3;
2002: $735.8;
2003: $814.6;
2004: $848.1;
2005: $897.1;
2006: $961.7;
2007: $1,013.3;
2008: $1,189.7.
Medical product programs[B]: Fiscal year appropriations;
1999: $441.2;
2000: $479.3;
2001: $492.1;
2002: $573.3;
2003: $612.7;
2004: $605.6;
2005: $629.6;
2006: $656.8;
2007: $692.1;
2008: $746.5.
Medical product programs[B]: User fees;
1999: $120.4;
2000: $142.9;
2001: $155.2;
2002: $162.6;
2003: $201.8;
2004: $242.5;
2005: $267.5;
2006: $304.9;
2007: $321.1;
2008: $443.2.
Other programs[C]:
1999: $568.3;
2000: $591.8;
2001: $630.9;
2002: $801.1;
2003: $813.1;
2004: $830.8;
2005: $880.4;
2006: $901.0;
2007: $960.8;
2008: $1,055.3.
Other programs[C]: Fiscal year appropriations;
1999: $544.0;
2000: $569.1;
2001: $607.2;
2002: $781.1;
2003: $777.3;
2004: $795.6;
2005: $822.7;
2006: $836.8;
2007: $890.5;
2008: $974.2.
Other programs[C]: User fees;
1999: $24.3;
2000: $23.0;
2001: $23.7;
2002: $20.0;
2003: $35.8;
2004: $35.2;
2005: $57.7;
2006: $64.3;
2007: $70.3;
2008: $81.1.
FDA total:
1999: $1,130.0;
2000: $1,214.0;
2001: $1,278.1;
2002: $1,537.0;
2003: $1,627.7;
2004: $1,678.9;
2005: $1,777.5;
2006: $1,862.7;
2007: $1,974.1;
2008: $2,245.0.
FDA total: Fiscal year appropriations;
1999: $985.3;
2000: $1,048.4;
2001: $1,099.3;
2002: $1,354.4;
2003: $1,390.1;
2004: $1,401.2;
2005: $1,452.3;
2006: $1,493.6;
2007: $1,582.7;
2008: $1,720.6.
FDA total: User fees;
1999: $144.7;
2000: $165.8;
2001: $178.8;
2002: $182.6;
2003: $237.6;
2004: $277.7;
2005: $325.2;
2006: $369.1;
2007: $391.4;
2008: $524.4.
Source: GAO analysis of FDA data.
Notes: We use the terms "user fee funding" to describe amounts derived
from user fee collections and "fiscal year appropriations" to describe
amounts derived from the General Fund of the Treasury. Both user fee
funding and fiscal year appropriations are made available through the
annual appropriations process. FDA uses the term "budget authority" to
refer to its fiscal year appropriations. Fiscal year appropriations and
user fees may not sum to totals due to rounding.
[A] In fiscal year 2004, FDA transferred oversight responsibilities for
certain biological products from the biologics program to the drugs
program.
[B] Medical product program resources reflect the sum of resources for
drugs, biologics, and devices.
[C] Other program resources reflect the sum of resources for all
nonmedical product programs, including those for FDA's Foods Program,
Animal Drugs and Feeds Program, the National Center for Toxicological
Research, the Office of the Commissioner, and rent and facilities.
[End of table]
Staffing resources supporting FDA's medical product programs--as
measured by the number of full-time equivalent (FTE) staff--varied from
year to year, and increased 14 percent between fiscal year 1999 and
fiscal year 2008.[Footnote 61] Specifically,
* drugs program FTEs increased 22 percent from 2,456 FTEs in fiscal
year 1999 to 2,996 FTEs in fiscal year 2008;
* biologics program FTEs increased 8 percent from 989 FTEs in fiscal
year 1999 to 1,066 in fiscal year 2008; and:
* devices program FTEs increased 6 percent from 1,480 FTEs in fiscal
year 1999 to 1,564 FTEs in fiscal year 2008.
Table 5 displays staffing resources for FDA programs from fiscal years
1999 through 2008.
Table 5: Staffing Resources for FDA Programs, Fiscal Years 1999 through
2008 (Full-time equivalents (FTE)):
Drugs program:
1999: 2,456;
2000: 2,509;
2001: 2,535;
2002: 2,517;
2003: 2,696;
2004: 2,949;
2005: 2,918;
2006: 2,947;
2007: 2,915;
2008: 2,996.
Drugs program: Fiscal year appropriations;
1999: 1,846;
2000: 1,838;
2001: 1,824;
2002: 1,817;
2003: 1,920;
2004: 1,943;
2005: 1,837;
2006: 1,801;
2007: 1,772;
2008: 1,712.
Drugs program: User fees;
1999: 610;
2000: 671;
2001: 711;
2002: 700;
2003: 776;
2004: 1,006;
2005: 1,081;
2006: 1,146;
2007: 1,143;
2008: 1,284.
Biologics program[A]:
1999: 989;
2000: 991;
2001: 1,041;
2002: 1,136;
2003: 1,229;
2004: 1,038;
2005: 1,041;
2006: 979;
2007: 1,045;
2008: 1,066.
Biologics program[A]: Fiscal year appropriations;
1999: 791;
2000: 780;
2001: 786;
2002: 894;
2003: 947;
2004: 792;
2005: 768;
2006: 730;
2007: 763;
2008: 725.
Biologics program[A]: User fees;
1999: 198;
2000: 211;
2001: 255;
2002: 242;
2003: 282;
2004: 246;
2005: 273;
2006: 249;
2007: 282;
2008: 342.
Devices program:
1999: 1,480;
2000: 1,472;
2001: 1,473;
2002: 1,454;
2003: 1,485;
2004: 1,515;
2005: 1,516;
2006: 1,498;
2007: 1,544;
2008: 1,564.
Devices program: Fiscal year appropriations;
1999: 1,432;
2000: 1,426;
2001: 1,428;
2002: 1,407;
2003: 1,432;
2004: 1,376;
2005: 1,367;
2006: 1,328;
2007: 1,358;
2008: 1,365.
Devices program: User fees;
1999: 48;
2000: 46;
2001: 45;
2002: 47;
2003: 53;
2004: 139;
2005: 149;
2006: 170;
2007: 186;
2008: 199.
Medical product programs[B]:
1999: 4,925;
2000: 4,972;
2001: 5,049;
2002: 5,107;
2003: 5,410;
2004: 5,502;
2005: 5,475;
2006: 5,424;
2007: 5,504;
2008: 5,626.
Medical product programs[B]: Fiscal year appropriations;
1999: 4,069;
2000: 4,044;
2001: 4,038;
2002: 4,118;
2003: 4,299;
2004: 4,111;
2005: 3,972;
2006: 3,859;
2007: 3,893;
2008: 3,802.
Medical product programs[B]: User fees;
1999: 856;
2000: 928;
2001: 1,011;
2002: 989;
2003: 1,111;
2004: 1,391;
2005: 1,503;
2006: 1,565;
2007: 1,611;
2008: 1,825.
Other programs[C]:
1999: 3,985;
2000: 3,858;
2001: 3,940;
2002: 4,361;
2003: 4,847;
2004: 4,639;
2005: 4,435;
2006: 4,274;
2007: 4,065;
2008: 4,185.
Other programs[C]: Fiscal year appropriations;
1999: 3,782;
2000: 3,684;
2001: 3,767;
2002: 4,193;
2003: 4,641;
2004: 4,456;
2005: 4,209;
2006: 4,034;
2007: 3,812;
2008: 3,876.
Other programs[C]: User fees;
1999: 203;
2000: 174;
2001: 173;
2002: 168;
2003: 206;
2004: 183;
2005: 226;
2006: 240;
2007: 253;
2008: 308.
FDA total:
1999: 8,910;
2000: 8,830;
2001: 8,989;
2002: 9,468;
2003: 10,257;
2004: 10,141;
2005: 9,910;
2006: 9,698;
2007: 9,569;
2008: 9,811.
FDA total: Fiscal year appropriations;
1999: 7,851;
2000: 7,728;
2001: 7,805;
2002: 8,311;
2003: 8,940;
2004: 8,567;
2005: 8,181;
2006: 7,893;
2007: 7,705;
2008: 7,678.
FDA total: User fees;
1999: 1,059;
2000: 1,102;
2001: 1,184;
2002: 1,157;
2003: 1,317;
2004: 1,574;
2005: 1,729;
2006: 1,805;
2007: 1,864;
2008: 2,133.
Source: GAO analysis of FDA data.
Notes: We use the terms "user fee funding" to describe amounts derived
from user fee collections and "fiscal year appropriations" to describe
amounts derived from the General Fund of the Treasury. Both user fee
funding and fiscal year appropriations are made available through the
annual appropriations process. FDA uses the term "budget authority" to
refer to its fiscal year appropriations. One FTE represents 40 hours of
work per week conducted by a federal government employee over the
course of 1 year and does not include contractors. Fiscal year
appropriations and user fees may not sum to totals due to rounding.
[A] In fiscal year 2004, FDA transferred oversight responsibilities for
certain biological products from the biologics program to the drugs
program.
[B] Medical product program resources reflect the sum of resources for
drugs, biologics, and devices.
[C] Other program resources reflect the sum of resources for all
nonmedical product programs, including those for FDA's Foods Program,
Animal Drugs and Feeds Program, the National Center for Toxicological
Research, the Office of the Commissioner, and rent and facilities.
[End of table]
[End of section]
Appendix II: Trends in Center and Field Resources for the Drugs,
Biologics, and Devices Programs:
Between fiscal years 2004 and 2008, the drugs, biologics, and devices
programs allocated most of their funding and staffing to center
activities, leaving a smaller share of resources for field activities.
Funding for center activities grew faster than funding for field
activities, which increased at nearly the same rate as inflation, as
measured by the gross domestic product (GDP) price index. During the
same period, staffing resources for center activities increased while
staffing resources for field activities decreased.
Trends in Funding Resources for Center and Field Activities:
Funding for center activities grew more than three times as fast as
funding for field activities between fiscal years 2004 and 2008.
Specifically, center funding for all medical product programs combined
grew from $675 million to $995 million over this period, an increase of
47 percent, while field funding for all medical programs increased from
$173 million to $195 million, an increase of 13 percent. (See figure
7.) While increases in total center funding outpaced the GDP inflation
rate of 12 percent during this period, the rate of increase in total
field funding remained close to the GDP inflation rate.
Figure 7: Annual Medical Product Program Funding for Center and Field
Activities, Fiscal Years 2004 through 2008:
[Refer to PDF for image: stacked line graph]
Fiscal year: 2004;
Field: $173 million;
Center: $675 million;
Total: $848 million.
Fiscal year: 2005;
Field: $175 million;
Center: $722 million;
Total: $897 million.
Fiscal year: 2006;
Field: $180 million;
Center: $782 million;
Total: $962 million.
Fiscal year: 2007;
Field: $188 million;
Center: $825 million;
Total: $1.0 billion.
Fiscal year: 2008;
Field: $195 million;
Center: $995 million;
Total: $1.2 billion.
Source: GAO analysis of FDA data.
[End of figure]
Drugs program funding for center activities conducted by the Center for
Drug Evaluation and Research (CDER) increased 57 percent from about
$373 million in fiscal year 2004 to about $588 million in fiscal year
2008, while funding for field activities conducted by the Office of
Regulatory Affairs (ORA) rose 8 percent from about $86 million to about
$93 million over this period. The increase in field funding for this
program was less than the rate of GDP inflation (12 percent) over this
period.
Biologics program funding for center activities conducted by the Center
for Biologics Evaluation and Research (CBER) increased 45 percent from
about $140 million in fiscal year 2004 to about $202 million in fiscal
year 2008, while funding for biologics field activities conducted by
ORA increased 15 percent over this period, from about $27 million to
about $31 million.
Devices program funding for center activities conducted by the Center
for Devices and Radiological Health (CDRH) increased 26 percent from
about $162 million in fiscal year 2004 to about $205 million in fiscal
years 2008, while funding for field activities conducted by ORA
increased 18 percent, from about $60 million to about $70 million.
Over two-thirds of each of the medical product centers' funding
supported their user fee activities in fiscal year 2008. Specifically,
CDER, CBER and CDRH each allocated about 78 percent of their centers'
total funding--including an average of 61 percent of the centers' total
fiscal year appropriations--to user fee activities in fiscal year 2008,
leaving 22 percent of funding to support the centers' other activities.
In contrast, 23 percent of the medical product programs' total field
funding supported user fee activities, with 77 percent of field funding
supporting other activities not funded with user fees. Table 6 displays
how the medical product programs allocated funding resources to
specific center and field activities.
Table 6: Medical Product Program Funding Resources for Center and Field
Activities, Fiscal Years 2004 through 2008 (Dollars in millions):
Activity: Drugs program: Center for Drug Evaluation and Research (CDER)
activities: Generic drug review;
Fiscal year: 2004: $34.0;
Fiscal year: 2005: $43.1;
Fiscal year: 2006: $44.4;
Fiscal year: 2007: $52.8;
Fiscal year: 2008: $64.6.
Activity: Drugs program: Center for Drug Evaluation and Research (CDER)
activities: New drug safety and effectiveness;
Fiscal year: 2004: $292.8;
Fiscal year: 2005: $302.0;
Fiscal year: 2006: $324.8;
Fiscal year: 2007: $321.4;
Fiscal year: 2008: $384.2.
Activity: Drugs program: Center for Drug Evaluation and Research (CDER)
activities: Postmarket safety and surveillance;
Fiscal year: 2004: $46.7;
Fiscal year: 2005: $51.0;
Fiscal year: 2006: $53.8;
Fiscal year: 2007: $80.0;
Fiscal year: 2008: $138.7.
Activity: Drugs program: CDER activities subtotal;
Fiscal year: 2004: $373.5;
Fiscal year: 2005: $396.0;
Fiscal year: 2006: $423.1;
Fiscal year: 2007: $454.2;
Fiscal year: 2008: $587.6.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Bioresearch monitoring;
Fiscal year: 2004: $14.0;
Fiscal year: 2005: $13.3;
Fiscal year: 2006: $14.1;
Fiscal year: 2007: $16.3;
Fiscal year: 2008: $17.6.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Generic drug evaluation;
Fiscal year: 2004: $5.4;
Fiscal year: 2005: $4.7;
Fiscal year: 2006: $4.0;
Fiscal year: 2007: $5.0;
Fiscal year: 2008: $5.0.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: New drug evaluation;
Fiscal year: 2004:$ 5.9;
Fiscal year: 2005: $5.1;
Fiscal year: 2006: $4.5;
Fiscal year: 2007: $5.8;
Fiscal year: 2008: $6.7.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Over-the-counter drug evaluation;
Fiscal year: 2004: $0.1;
Fiscal year: 2005: $0.1;
Fiscal year: 2006: $0.1;
Fiscal year: 2007: 0.0;
Fiscal year: 2008: $0.2.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Postmarket surveillance and epidemiology;
Fiscal year: 2004: $1.1;
Fiscal year: 2005: $1.6;
Fiscal year: 2006: $1.6;
Fiscal year: 2007: $1.3;
Fiscal year: 2008: $1.8.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Prescription drug advertising and labeling;
Fiscal year: 2004: $0.1;
Fiscal year: 2005: 0.0;
Fiscal year: 2006: 0.0;
Fiscal year: 2007: $0.1;
Fiscal year: 2008: 0.0.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Quality assurance;
Fiscal year: 2004: $58.3;
Fiscal year: 2005: $59.9;
Fiscal year: 2006: $59.9;
Fiscal year: 2007: $59.0;
Fiscal year: 2008: $58.7.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Unapproved and misbranded drugs;
Fiscal year: 2004: $1.4;
Fiscal year: 2005: $1.3;
Fiscal year: 2006: $1.6;
Fiscal year: 2007: $1.8;
Fiscal year: 2008: $3.4.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Field activities subtotal;
Fiscal year: 2004: $86.1;
Fiscal year: 2005: $86.1;
Fiscal year: 2006: $85.8;
Fiscal year: 2007: $89.3;
Fiscal year: 2008: $93.4.
Activity: Drugs program total;
Fiscal year: 2004: $459.6;
Fiscal year: 2005: $482.1;
Fiscal year: 2006: $508.9;
Fiscal year: 2007: $543.6;
Fiscal year: 2008: $680.9.
Activity: Biologics Program: Center for Biologics Evaluation and
Research (CBER) activities: Blood and blood products;
Fiscal year: 2004: $50.2;
Fiscal year: 2005: $51.3;
Fiscal year: 2006: $64.3;
Fiscal year: 2007: $62.7;
Fiscal year: 2008: $72.9.
Activity: Biologics Program: Center for Biologics Evaluation and
Research (CBER) activities: Cell, gene therapy, and tissues;
Fiscal year: 2004: $22.4;
Fiscal year: 2005: $22.0;
Fiscal year: 2006: $25.8;
Fiscal year: 2007: $28.9;
Fiscal year: 2008: $32.8.
Activity: Biologics Program: Center for Biologics Evaluation and
Research (CBER) activities: Vaccines and allergenic products;
Fiscal year: 2004: $67.3;
Fiscal year: 2005: $69.7;
Fiscal year: 2006: $78.7;
Fiscal year: 2007: $80.5;
Fiscal year: 2008: $96.5.
Activity: Biologics Program: CBER activities subtotal;
Fiscal year: 2004: $139.9;
Fiscal year: 2005: $143.0;
Fiscal year: 2006: $168.9;
Fiscal year: 2007: $172.0;
Fiscal year: 2008: $202.3.
Activity: Biologics Program: ORA field activities: Blood and blood
products;
Fiscal year: 2004: $22.1;
Fiscal year: 2005: $21.8;
Fiscal year: 2006: $20.2;
Fiscal year: 2007: $20.0;
Fiscal year: 2008: $22.1.
Activity: Biologics Program: ORA field activities: Cell, gene therapy,
and tissues;
Fiscal year: 2004: $3.7;
Fiscal year: 2005: $3.2;
Fiscal year: 2006: $6.2;
Fiscal year: 2007: $7.5;
Fiscal year: 2008: $5.8.
Activity: Biologics Program: ORA field activities: Vaccines and
allergenic products;
Fiscal year: 2004: v1.4;
Fiscal year: 2005: $2.6;
Fiscal year: 2006: $2.4;
Fiscal year: 2007: $2.6;
Fiscal year: 2008: $3.3.
Activity: Biologics Program: Field activities subtotal;
Fiscal year: 2004: $27.1;
Fiscal year: 2005: $27.7;
Fiscal year: 2006: $28.8;
Fiscal year: 2007: $30.1;
Fiscal year: 2008: $31.2.
Activity: Biologics program total;
Fiscal year: 2004: $167.0;
Fiscal year: 2005: $170.7;
Fiscal year: 2006: $197.7;
Fiscal year: 2007: $202.2;
Fiscal year: 2008: $233.5.
Activity: Devices Program: Center for Devices and Radiological Health
(CDRH) activities: Premarket applied research;
Fiscal year: 2004: $9.3;
Fiscal year: 2005: $10.2;
Fiscal year: 2006: $9.1;
Fiscal year: 2007: $8.9;
Fiscal year: 2008: $10.9.
Activity: Devices Program: Center for Devices and Radiological Health
(CDRH) activities: Premarket outreach and coordination;
Fiscal year: 2004: $6.2;
Fiscal year: 2005: $6.8;
Fiscal year: 2006: $10.5;
Fiscal year: 2007: $8.4;
Fiscal year: 2008: $9.2.
Activity: Devices Program: Center for Devices and Radiological Health
(CDRH) activities: Premarket review;
Fiscal year: 2004: $73.5;
Fiscal year: 2005: $89.8;
Fiscal year: 2006: $118.1;
Fiscal year: 2007: $119.2;
Fiscal year: 2008: $101.1.
Activity: Devices Program: Center for Devices and Radiological Health
(CDRH) activities: Postmarket applied research;
Fiscal year: 2004: $2.9;
Fiscal year: 2005: $2.2;
Fiscal year: 2006: $0.9;
Fiscal year: 2007: $1.2;
Fiscal year: 2008: $1.3.
Activity: Devices Program: Center for Devices and Radiological Health
(CDRH) activities: Postmarket laboratory analysis;
Fiscal year: 2004: $8.5;
Fiscal year: 2005: $13.8;
Fiscal year: 2006: $5.8;
Fiscal year: 2007: $6.7;
Fiscal year: 2008: $11.1.
Activity: Devices Program: Center for Devices and Radiological Health
(CDRH) activities: Postmarket outreach, coordination, and compliance;
Fiscal year: 2004: $61.5;
Fiscal year: 2005: $60.4;
Fiscal year: 2006: $45.4;
Fiscal year: 2007: $54.4;
Fiscal year: 2008: $71.2.
Activity: Devices Program: CDRH activities subtotal;
Fiscal year: 2004: $161.9;
Fiscal year: 2005: $183.2;
Fiscal year: 2006: $189.8;
Fiscal year: 2007: $198.7;
Fiscal year: 2008: $204.8.
Activity: Devices Program: ORA field activities: Compliance;
Fiscal year: 2004: $38.8;
Fiscal year: 2005: $42.4;
Fiscal year: 2006: $45.4;
Fiscal year: 2007: $47.6;
Fiscal year: 2008: $49.0.
Activity: Devices Program: ORA field activities: Mammography Quality
Standards Act Authority;
Fiscal year: 2004: $2.1;
Fiscal year: 2005: $2.4;
Fiscal year: 2006: $2.4;
Fiscal year: 2007: $2.7;
Fiscal year: 2008: $2.7.
Activity: Devices Program: ORA field activities: Postmarket assurance;
Fiscal year: 2004: $1.9;
Fiscal year: 2005: $2.5;
Fiscal year: 2006: $2.6;
Fiscal year: 2007: $2.8;
Fiscal year: 2008: $3.5.
Activity: Devices Program: ORA field activities: Product Evaluation;
Fiscal year: 2004: $10.0;
Fiscal year: 2005: $8.0;
Fiscal year: 2006: $9.2;
Fiscal year: 2007: $10.2;
Fiscal year: 2008: $10.2.
Activity: Devices Program: ORA field activities: Radiation Control for
Health and Safety Act Authority;
Fiscal year: 2004: $5.8;
Fiscal year: 2005: $5.1;
Fiscal year: 2006: $5.0;
Fiscal year: 2007: $4.9;
Fiscal year: 2008: $4.8.
Activity: Devices Program: ORA field activities: Science;
Fiscal year: 2004: $1.0;
Fiscal year: 2005: $0.8;
Fiscal year: 2006: $0.7;
Fiscal year: 2007: $0.7;
Fiscal year: 2008: $0.3.
Activity: Devices Program: Field activities subtotal;
Fiscal year: 2004: $59.6;
Fiscal year: 2005: $61.1;
Fiscal year: 2006: $65.2;
Fiscal year: 2007: $68.8;
Fiscal year: 2008: $70.5.
Activity: Devices program total;
Fiscal year: 2004: $221.5;
Fiscal year: 2005: $244.3;
Fiscal year: 2006: $255.0;
Fiscal year: 2007: $267.5;
Fiscal year: 2008: $275.3.
Source: FDA.
Note: Totals may not sum due to rounding.
[End of table]
Trends in Center and Field Staffing Resources:
The number of full-time equivalent (FTE) staff supporting center
activities grew 8 percent from 4,048 FTEs in fiscal year 2004 to 4,384
in fiscal year 2008, while the number of FTEs supporting field
activities conducted by ORA decreased 15 percent from 1,454 FTEs in
fiscal year 2004 to 1,243 FTEs in fiscal year 2008. (See figure 8.)
Because counts of FTEs do not include contractors, these data do not
fully represent FDA's staffing resources for these activities.
Figure 8: Annual Medical Product Program Staffing Resources for Center
and Field Activities, Fiscal Years 2004 through 2008:
[Refer to PDF for image: stacked line graph]
[Refer to PDF for image: stacked line graph]
Fiscal year: 2004;
Field: 1,454;
Center: 4,048;
Total: 5,502.
Fiscal year: 2005;
Field: 1,333;
Center: 4,142;
Total: 5,475.
Fiscal year: 2006;
Field: 1,281;
Center: 4,143;
Total: 5,425.
Fiscal year: 2007;
Field: 1,265;
Center: 4,239;
Total: 5,504.
Fiscal year: 2008;
Field: 1,243;
Center: 4,384;
Total: 5,627.
Source: GAO analysis of FDA data.
Note: One FTE represents 40 hours of work per week conducted by a
federal government employee over the course of 1 year and does not
include contractors.
[End of figure]
* Drugs program staffing resources for CDER activities grew 9 percent
from 2,190 FTEs in fiscal year 2004 to 2,396 FTEs in fiscal year 2008,
while staffing resources for drugs field activities declined 21 percent
from 759 FTEs in fiscal year 2004 to 600 FTEs in fiscal year 2008.
* Biologics program staffing resources for CBER activities grew 8
percent from 797 FTEs to 858 FTEs, while FTEs supporting biologics
field activities declined 13 percent from 241 FTEs to 209 FTEs.
* Devices program staffing resources for CDRH activities grew 7 percent
from 1,061 FTEs to 1,130 FTEs, while staffing resources for devices
field activities declined 4 percent from 454 FTEs to 434 FTEs.
Table 7 shows how FDA's medical product programs allocated FTE
resources to various center and field activities.
Table 7: Medical Product Program Staffing Resources for Center and
Field Activities, Fiscal Years 2004 through 2008 (Full-time equivalents
(FTE)):
Activity: Drugs program: Center for Drug Evaluation and Research (CDER)
activities: Generic drug review;
Fiscal year: 2004: 260;
Fiscal year: 2005: 257;
Fiscal year: 2006: 250;
Fiscal year: 2007: 248;
Fiscal year: 2008: 287.
Activity: Drugs program: Center for Drug Evaluation and Research (CDER)
activities: New drug safety and effectiveness;
Fiscal year: 2004: 1,673;
Fiscal year: 2005: 1,683;
Fiscal year: 2006: 1,767;
Fiscal year: 2007: 1,583;
Fiscal year: 2008: 1,608.
Activity: Drugs program: Center for Drug Evaluation and Research (CDER)
activities: Postmarket safety and surveillance;
Fiscal year: 2004: 257;
Fiscal year: 2005: 280;
Fiscal year: 2006: 269;
Fiscal year: 2007: 457;
Fiscal year: 2008: 501.
Activity: Drugs program: CDER activities subtotal;
Fiscal year: 2004: 2,190;
Fiscal year: 2005: 2,220;
Fiscal year: 2006: 2,286;
Fiscal year: 2007: 2,288;
Fiscal year: 2008: 2,396.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Bioresearch monitoring;
Fiscal year: 2004: 123;
Fiscal year: 2005: 108;
Fiscal year: 2006: 108;
Fiscal year: 2007: 115;
Fiscal year: 2008: 113.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Generic drug evaluation;
Fiscal year: 2004: 47;
Fiscal year: 2005: 38;
Fiscal year: 2006: 31;
Fiscal year: 2007: 35;
Fiscal year: 2008: 32.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: New drug evaluation;
Fiscal year: 2004: 52;
Fiscal year: 2005: 41;
Fiscal year: 2006: 35;
Fiscal year: 2007: 41;
Fiscal year: 2008: 43.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Over-the-counter drug evaluation;
Fiscal year: 2004: 1;
Fiscal year: 2005: 1;
Fiscal year: 2006: 1;
Fiscal year: 2007: 0;
Fiscal year: 2008: 1.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Postmarket surveillance and epidemiology;
Fiscal year: 2004: 9;
Fiscal year: 2005: 13;
Fiscal year: 2006: 13;
Fiscal year: 2007: 9;
Fiscal year: 2008: 12.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Prescription drug advertising and labeling;
Fiscal year: 2004: 0;
Fiscal year: 2005: 0;
Fiscal year: 2006: 0;
Fiscal year: 2007: 1;
Fiscal year: 2008: 0.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Quality assurance;
Fiscal year: 2004: 514;
Fiscal year: 2005: 485;
Fiscal year: 2006: 461;
Fiscal year: 2007: 414;
Fiscal year: 2008: 377.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities: Unapproved and misbranded drugs;
Fiscal year: 2004: 12;
Fiscal year: 2005: 11;
Fiscal year: 2006: 13;
Fiscal year: 2007: 12;
Fiscal year: 2008: 22.
Activity: Drugs program: Office of Regulatory Affairs (ORA) field
activities subtotal;
Fiscal year: 2004: 759;
Fiscal year: 2005: 698;
Fiscal year: 2006: 661;
Fiscal year: 2007: 627;
Fiscal year: 2008: 600.
Activity: Drugs program total;
Fiscal year: 2004: 2,949;
Fiscal year: 2005: 2,918;
Fiscal year: 2006: 2,947;
Fiscal year: 2007: 2,915;
Fiscal year: 2008: 2,996.
Activity: Biologics program: Center for Biologics Evaluation and
Research (CBER) activities: Blood and blood products;
Fiscal year: 2004: 286;
Fiscal year: 2005: 294;
Fiscal year: 2006: 294;
Fiscal year: 2007: 301;
Fiscal year: 2008: 309.
Activity: Biologics program: Center for Biologics Evaluation and
Research (CBER) activities: Cell, gene therapy, and tissues;
Fiscal year: 2004: 128;
Fiscal year: 2005: 126;
Fiscal year: 2006: 119;
Fiscal year: 2007: 138;
Fiscal year: 2008: 139.
Activity: Biologics program: Center for Biologics Evaluation and
Research (CBER) activities: Vaccines and allergenic products;
Fiscal year: 2004: 383;
Fiscal year: 2005: 398;
Fiscal year: 2006: 359;
Fiscal year: 2007: 388;
Fiscal year: 2008: 409.
Activity: Biologics program: CBER activities subtotal;
Fiscal year: 2004: 797;
Fiscal year: 2005: 818;
Fiscal year: 2006: 772;
Fiscal year: 2007: 827;
Fiscal year: 2008: 858.
Activity: Biologics program: ORA field activities: Blood and blood
products;
Fiscal year: 2004: 196;
Fiscal year: 2005: 176;
Fiscal year: 2006: 146;
Fiscal year: 2007: 145;
Fiscal year: 2008: 148.
Activity: Biologics program: ORA field activities: Cell, gene therapy,
and tissues;
Fiscal year: 2004: 32;
Fiscal year: 2005: 26;
Fiscal year: 2006: 44;
Fiscal year: 2007: 54;
Fiscal year: 2008: 39.
Activity: Biologics program: ORA field activities: Vaccines and
allergenic products;
Fiscal year: 2004: 13;
Fiscal year: 2005: 21;
Fiscal year: 2006: 17;
Fiscal year: 2007: 19;
Fiscal year: 2008: 22.
Activity: Biologics program: ORA field activities subtotal;
Fiscal year: 2004: 241;
Fiscal year: 2005: 223;
Fiscal year: 2006: 207;
Fiscal year: 2007: 218;
Fiscal year: 2008: 209.
Activity: Biologics program total;
Fiscal year: 2004: 1,038;
Fiscal year: 2005: 1,041;
Fiscal year: 2006: 979;
Fiscal year: 2007: 1,045;
Fiscal year: 2008: 1,066.
Activity: Devices program: Center for Devices and Radiological Health
(CDRH) activities: Premarket applied research;
Fiscal year: 2004: 59;
Fiscal year: 2005: 58;
Fiscal year: 2006: 54;
Fiscal year: 2007: 54;
Fiscal year: 2008: 51.
Activity: Devices program: Center for Devices and Radiological Health
(CDRH) activities: Premarket outreach and coordination;
Fiscal year: 2004: 42;
Fiscal year: 2005: 46;
Fiscal year: 2006: 51;
Fiscal year: 2007: 43;
Fiscal year: 2008: 68.
Activity: Devices program: Center for Devices and Radiological Health
(CDRH) activities: Premarket review; Fiscal year: 2004: 516; Fiscal
year: 2005: 566; Fiscal year: 2006: 578; Fiscal year: 2007: 634; Fiscal
year: 2008: 618.
Activity: Devices program: Center for Devices and Radiological Health
(CDRH) activities: Postmarket applied research;
Fiscal year: 2004: 19;
Fiscal year: 2005: 15;
Fiscal year: 2006: 7;
Fiscal year: 2007: 9;
Fiscal year: 2008: 7.
Activity: Devices program: Center for Devices and Radiological Health
(CDRH) activities: Postmarket laboratory analysis;
Fiscal year: 2004: 57;
Fiscal year: 2005: 82;
Fiscal year: 2006: 54;
Fiscal year: 2007: 51;
Fiscal year: 2008: 48.
Activity: Devices program: Center for Devices and Radiological Health
(CDRH) activities: Postmarket outreach, coordination, and compliance;
Fiscal year: 2004: 368;
Fiscal year: 2005: 337;
Fiscal year: 2006: 341;
Fiscal year: 2007: 333;
Fiscal year: 2008: 338.
Activity: Devices program: Center for Devices and Radiological Health
(CDRH) activities subtotal;
Fiscal year: 2004: 1,061;
Fiscal year: 2005: 1,104;
Fiscal year: 2006: 1,085;
Fiscal year: 2007: 1,124;
Fiscal year: 2008: 1,130.
Activity: Devices program: ORA field activities: Compliance;
Fiscal year: 2004: 296;
Fiscal year: 2005: 286;
Fiscal year: 2006: 287;
Fiscal year: 2007: 290;
Fiscal year: 2008: 301.
Activity: Devices program: ORA field activities: Mammography Quality
Standards Act Authority;
Fiscal year: 2004: 16;
Fiscal year: 2005: 16;
Fiscal year: 2006: 15;
Fiscal year: 2007: 16;
Fiscal year: 2008: 16.
Activity: Devices program: ORA field activities: Postmarket assurance;
Fiscal year: 2004: 15;
Fiscal year: 2005: 17;
Fiscal year: 2006: 16;
Fiscal year: 2007: 17;
Fiscal year: 2008: 22.
Activity: Devices program: ORA field activities: Product Evaluation;
Fiscal year: 2004: 76;
Fiscal year: 2005: 54;
Fiscal year: 2006: 58;
Fiscal year: 2007: 62;
Fiscal year: 2008: 63.
Activity: Devices program: ORA field activities: Radiation Control for
Health and Safety Act Authority;
Fiscal year: 2004: 44;
Fiscal year: 2005: 34;
Fiscal year: 2006: 31;
Fiscal year: 2007: 30;
Fiscal year: 2008: 30.
Activity: Devices program: ORA field activities: Science;
Fiscal year: 2004: 7;
Fiscal year: 2005: 5;
Fiscal year: 2006: 5;
Fiscal year: 2007: 4;
Fiscal year: 2008: 2.
Activity: Devices program: ORA field activities subtotal;
Fiscal year: 2004: 454;
Fiscal year: 2005: 412;
Fiscal year: 2006: 413;
Fiscal year: 2007: 420;
Fiscal year: 2008: 434.
Activity: Devices program total;
Fiscal year: 2004: 1,515;
Fiscal year: 2005: 1,516;
Fiscal year: 2006: 1,498;
Fiscal year: 2007: 1,544;
Fiscal year: 2008: 1,564.
Source: FDA.
Notes: One FTE represents 40 hours of work per week conducted by a
federal government employee over the course of 1 year and does not
include contractors. Totals may not sum due to rounding.
[End of table]
[End of section]
Appendix III: Trends in FDA's Review of Generic Drug, New Drug and New
Biologic Applications:
The Food and Drug Administration (FDA) faced an increasing workload
related to the process for reviewing generic drug, new drug, and new
biologic applications between fiscal year 2004 and fiscal year 2008.
For example, FDA received 47 percent more applications for generic
drugs in fiscal year 2008 than in fiscal year 2004. Even though FDA
funding for the review of these applications grew 53 percent over this
time period, agency officials said that resource constraints precluded
them from reviewing all applications submitted, resulting in a growing
number of applications pending review.
Trends in Reviewing Generic Drug, New Drug, and New Biologic
Applications:
FDA reviewed an increasing number of abbreviated new drug applications
(ANDA) for generic drugs between fiscal years 2004 and 2008. However,
FDA received a greater number of applications each year than it was
able to review. The number of original ANDAs received for review
increased by 47 percent--from 563 in fiscal year 2004 to 830 in fiscal
year 2008. During this time period, FDA reviewed an increasing number
of ANDAs each year. In fiscal year 2004, FDA reviewed 1,357 ANDAs and
in fiscal year 2008 the agency reviewed 1,933 ANDAs--an increase of 42
percent.[Footnote 62] While the number of ANDAs the agency reviewed
each year increased, FDA was not able to review them all. As a result,
the number of applications pending review increased 123 percent over
the period. (See table 8.) FDA officials told us that they were unable
to review all ANDAs because they did not have enough resources to
conduct these reviews.
Table 8: Elements of FDA's Oversight Work Related to the Process of
Reviewing ANDAs, Fiscal Years 2004 through 2008:
Original ANDAs received:
Fiscal year: 2004: 563;
Fiscal year: 2005: 766;
Fiscal year: 2006: 793;
Fiscal year: 2007: 880;
Fiscal year: 2008: 830.
ANDAs reviewed:
Fiscal year: 2004: 1,357;
Fiscal year: 2005: 1,496;
Fiscal year: 2006: 1,456;
Fiscal year: 2007: 1,779;
Fiscal year: 2008: 1,933.
ANDA supplements reviewed (manufacturing and labeling):
Fiscal year: 2004: 4,630;
Fiscal year: 2005: 4,566;
Fiscal year: 2006: 4,577;
Fiscal year: 2007: 3,720;
Fiscal year: 2008: 3,516.
ANDAs pending review:
Fiscal year: 2004: 646;
Fiscal year: 2005: 891;
Fiscal year: 2006: 1,216;
Fiscal year: 2007: 1,344;
Fiscal year: 2008: 1,441.
Source: FDA.
Note: The number of ANDAs FDA reviewed exceeds the number received in a
particular year because FDA may have completed its review of original
ANDAs submitted during prior years, or may have reviewed resubmitted
applications.
[End of table]
Between fiscal year 2004 and fiscal year 2008, FDA conducted an
increased amount of work related to the review of new drug and new
biologic applications. In particular, FDA was increasingly involved in
the process of new drug and new biologic development, which typically
occurs years before sponsors submit a new drug application (NDA) or
biologics license application (BLA) to FDA for approval. FDA reported
that sponsors' early consultation with the agency generally results in
improvements in the safety and effectiveness of the clinical trials. In
addition, FDA indicated that the agency's increased involvement
generally improves the quality of information submitted in an
application for marketing approval and increases the likelihood that
the resulting application will gain faster approval.
The number of active investigational new drugs (IND)--representing new
drugs and new biologics in development--grew from 12,523 in fiscal year
2004 to 15,020 in fiscal year 2008. To guide the development of these
new products, FDA issued an increasing number of written guidance
documents to sponsors between fiscal year 2004 and fiscal year 2008.
For example, FDA issued 135 responses to clinical holds in fiscal year
2004 and 213 such responses in fiscal year 2008. In addition, while the
number of meetings FDA conducted with sponsors regarding new drug
development varied from year to year, between fiscal year 2004 and
fiscal year 2008 FDA scheduled over 10,000 meetings with sponsors, with
between 1,900 and 2,300 such meetings each year. (See table 9.) FDA
officials stated that drafting written responses and preparing for and
documenting the results of meetings with sponsors requires a
substantial amount of staff time. In particular, FDA noted that each
meeting typically requires the involvement of at least 15 FDA staff and
can require between 120 to 540 hours of staff time.
Table 9: Elements of FDA's Oversight Work Related to the Process of New
Drug Development and Application Review, Fiscal Years 2004 through
2008:
New drug development: Active INDs;
Fiscal year: 2004: 12,523;
Fiscal year: 2005: 13,106;
Fiscal year: 2006: 13,881;
Fiscal year: 2007: 14,820;
Fiscal year: 2008: 15,020[A].
New drug development: Responses to clinical holds;
Fiscal year: 2004: 135;
Fiscal year: 2005: 130;
Fiscal year: 2006: 145;
Fiscal year: 2007: 175;
Fiscal year: 2008: 213.
New drug development: Special protocol assessments;
Fiscal year: 2004: 346;
Fiscal year: 2005: 396;
Fiscal year: 2006: 406;
Fiscal year: 2007: 459;
Fiscal year: 2008: 354.
New drug development: Responses to sponsor appeals of a decision (major
dispute resolutions);
Fiscal year: 2004: 10;
Fiscal year: 2005: 9;
Fiscal year: 2006: 9;
Fiscal year: 2007: 22;
Fiscal year: 2008: 14.
New drug development: Meetings scheduled;
Fiscal year: 2004: 2,125;
Fiscal year: 2005: 2,230;
Fiscal year: 2006: 2,273;
Fiscal year: 2007: 2,151;
Fiscal year: 2008: 1,903.
Applications: Original NDAs and BLAs received and filed;
Fiscal year: 2004: 129;
Fiscal year: 2005: 111;
Fiscal year: 2006: 124;
Fiscal year: 2007: 123;
Fiscal year: 2008: 143.
Applications: Resubmitted NDAs and BLAs;
Fiscal year: 2004: 85;
Fiscal year: 2005: 59;
Fiscal year: 2006: 61;
Fiscal year: 2007: 73;
Fiscal year: 2008: 54.
Applications: Total number of original and resubmitted NDAs and BLAs;
Fiscal year: 2004: 214;
Fiscal year: 2005: 170;
Fiscal year: 2006: 185;
Fiscal year: 2007: 196;
Fiscal year: 2008: 197.
Applications: NDAs and BLAs reviewed;
Fiscal year: 2004: 206;
Fiscal year: 2005: 192;
Fiscal year: 2006: 177;
Fiscal year: 2007: 184;
Fiscal year: 2008: 161.
Applications: NDA and BLA supplements (efficacy, labeling and
manufacturing) reviewed;
Fiscal year: 2004: 3,918;
Fiscal year: 2005: 3,725;
Fiscal year: 2006: 3,822;
Fiscal year: 2007: 4,045;
Fiscal year: 2008: 3,721.
Source: FDA.
Note: Our examination of FDA's review of BLAs was restricted to those
subject to certain performance goals. The total number of applications
FDA reviewed may exceed the number FDA received in a particular year
because FDA may have completed its review of applications submitted
during prior years, or may have reviewed resubmitted applications.
[A] FDA estimate.
[End of table]
Although FDA was increasingly involved in the process of new drug and
new biologic development between fiscal year 2004 and fiscal year 2008,
the agency's review of NDAs and BLAs decreased slightly over the time
period, following trends in the number of applications the agency
received. As shown in table 9, the total number of original and
resubmitted NDAs and BLAs FDA received decreased from 214 applications
in fiscal year 2004 to 197 applications in fiscal year 2008.[Footnote
63] FDA also reviewed a decreasing number of NDAs and BLAs--in fiscal
year 2004 FDA reviewed 206 original and resubmitted NDAs and BLAs and
in fiscal year 2008 FDA reviewed 161 such applications. FDA also
reviewed between about 3,700 and 4,000 efficacy, labeling, and
manufacturing NDA and BLA supplements each year during this period.
FDA has many performance goals related to its process for reviewing new
drug applications. According to FDA officials, the agency places a
higher priority on the speed with which it reviews applications for new
drugs and biologics, compared to the speed with which the agency
responds to sponsor requests for information and scheduling and holding
meetings with sponsors. As a result of this prioritization, FDA focused
its resources on its review of applications--and we found FDA generally
met its performance goals in this area. However, agency officials noted
that the agency did not have sufficient resources to meet performance
goals related to responding to sponsor requests for information and
scheduling and holding meetings.
Trends in Resources for Reviewing Generic Drug, New Drug, and New
Biologic Applications:
Between fiscal year 2004 and fiscal year 2008, funding for FDA's review
of ANDAs--which is provided solely through FDA's fiscal year
appropriations--increased 53 percent from about $53 million in fiscal
year 2004 to about $82 million in fiscal year 2008. Over the same
period, funding resources for FDA's process for reviewing NDAs and
BLAs, an activity that receives both user fee funding and fiscal year
appropriations, increased 58 percent. Specifically, funding increased
from $437 million in fiscal year 2004 to $691 million in fiscal year
2008.
During the same period, the number of full-time equivalent (FTE) staff
supporting the agency's review of ANDAs decreased 12 percent from 427
FTEs in fiscal year 2004 to 376 FTEs in fiscal year 2008. In contrast,
the number of FTEs supporting the agency's review of new drug and new
biologic applications increased from 2,561 FTEs in fiscal year 2004 to
2,780 FTEs in fiscal year 2008. This increase in FTEs was solely due to
an increase in the number of FTEs funded by user fees. Because counts
of FTEs do not include contractors, these data do not fully represent
FDA's staffing resources for these activities.
[End of section]
Appendix IV: Trends in FDA Inspections Conducted to Oversee Medical
Product Research and Manufacturing:
Between fiscal years 2004 and 2008, the number of medical product
inspections the Food and Drug Administration (FDA) conducted decreased
17 percent--primarily due to a 19 percent decrease in the number of
domestic inspections. Although the total number of inspections
decreased, funding for inspections grew 16 percent overall, and the
rate of funding increases for drugs and biologics inspections did not
keep pace with inflation, as measured by the gross domestic product
(GDP) price index. The agency conducted an increasing number of foreign
inspections, which on average cost more than twice as much as each
domestic inspection, and may explain why increased inspection funding
supported a fewer number of total inspections.
Trends in Conducting Inspections:
The total number of inspections FDA conducted for its medical product
programs decreased from 7,589 inspections in fiscal year 2004 to 6,306
inspections in fiscal year 2008, a decline of 1,283 inspections or 17
percent. The total number of inspections conducted for each program
decreased over the time period. (See figure 9.)
Figure 9: Medical Product Program Inspections, Fiscal Years 2004
through 2008:
[Refer to PDF for image: stacked line graph]
Fiscal year: 2004;
Devices: 2,948;
Biologics: 2,026;
Drugs: 2,615;
Total: 7,589.
Fiscal year: 2005;
Devices: 2,703;
Biologics: 1,933;
Drugs: 2,692;
Total: 7,328.
Fiscal year: 2006;
Devices: 2,696;
Biologics: 1,835;
Drugs: 2,403;
Total: 6,934.
Fiscal year: 2007;
Devices: 2,498;
Biologics: 1,888;
Drugs: 2,318;
Total: 6,704.
Fiscal year: 2008;
Devices: 2,354;
Biologics: 1,728;
Drugs: 2,224;
Total: 6,306.
Source: FDA.
[End of figure]
Between fiscal years 2004 and 2008, FDA decreased the number of
domestic medical product program inspections conducted each year. FDA
conducted 6,849 domestic inspections in fiscal year 2004 and 5,543
domestic inspections in fiscal year 2008--a decline of 19 percent or
1,306 inspections over the 5-year time period. FDA reduced the number
of domestic inspections it conducted for each of the medical product
programs between fiscal years 2004 and 2008.
* For the drugs program, FDA conducted 2,241 domestic inspections in
fiscal year 2004 and 1,772 such inspections in fiscal year 2008--a
decrease of 469 inspections or 21 percent.
* For the biologics program, FDA conducted 2,009 domestic inspections
in fiscal year 2004 and 1,678 domestic inspections in fiscal year 2008,
a decrease of 331 inspections or 16 percent.
* For the devices program, FDA conducted 2,599 domestic inspections in
fiscal year 2004 and 2,093 domestic inspections in fiscal year 2008, a
decline of 506 inspections or 19 percent.
FDA conducted fewer domestic medical product inspections overall,
although the agency increased the number of certain types of domestic
inspections.[Footnote 64] For example, within the biologics program,
FDA increased the number of domestic inspections of human cellular,
tissue, and gene therapy products, and vaccines and allergenic products
between fiscal years 2004 and 2008. In addition, FDA increased the
number of domestic postmarket assurance device inspections it conducted
over the 5 year period. (See table 10.)
Table 10: Number of Domestic and Foreign Inspections for the Drugs,
Biologics, and Devices Programs, Fiscal Years 2004 through 2008:
Drugs Program: Bioresearch monitoring;
Fiscal year: 2004: Domestic: 599;
Fiscal year: 2004: Foreign: 105;
Fiscal year: 2005: Domestic: 567;
Fiscal year: 2005: Foreign: 93;
Fiscal year: 2006: Domestic: 508;
Fiscal year: 2006: Foreign: 122;
Fiscal year: 2007: Domestic: 495;
Fiscal year: 2007: Foreign: 155;
Fiscal year: 2008: Domestic: 531;
Fiscal year: 2008: Foreign: 129.
Drugs Program: Generic drug evaluation;
Fiscal year: 2004: Domestic: 82;
Fiscal year: 2004: Foreign: 87;
Fiscal year: 2005: Domestic: 90;
Fiscal year: 2005: Foreign: 79;
Fiscal year: 2006: Domestic: 82;
Fiscal year: 2006: Foreign: 78;
Fiscal year: 2007: Domestic: 84;
Fiscal year: 2007: Foreign: 141;
Fiscal year: 2008: Domestic: 101;
Fiscal year: 2008: Foreign: 117.
Drugs Program: New drug evaluation;
Fiscal year: 2004: Domestic: 196;
Fiscal year: 2004: Foreign: 156;
Fiscal year: 2005: Domestic: 152;
Fiscal year: 2005: Foreign: 166;
Fiscal year: 2006: Domestic: 139;
Fiscal year: 2006: Foreign: 123;
Fiscal year: 2007: Domestic: 135;
Fiscal year: 2007: Foreign: 169;
Fiscal year: 2008: Domestic: 139;
Fiscal year: 2008: Foreign: 174.
Drugs Program: Over-the-counter drug evaluation;
Fiscal year: 2004: Domestic: 19;
Fiscal year: 2004: Foreign: 0;
Fiscal year: 2005: Domestic: 12;
Fiscal year: 2005: Foreign: 1;
Fiscal year: 2006: Domestic: 2;
Fiscal year: 2006: Foreign: 0;
Fiscal year: 2007: Domestic: 1;
Fiscal year: 2007: Foreign: 0;
Fiscal year: 2008: Domestic: [Empty];
Fiscal year: 2008: Foreign: 0.
Drugs Program: Postmarket surveillance and epidemiology;
Fiscal year: 2004: Domestic: 78;
Fiscal year: 2004: Foreign: 11;
Fiscal year: 2005: Domestic: 105;
Fiscal year: 2005: Foreign: 11;
Fiscal year: 2006: Domestic: 105;
Fiscal year: 2006: Foreign: 10;
Fiscal year: 2007: Domestic: 89;
Fiscal year: 2007: Foreign: 9;
Fiscal year: 2008: Domestic: 89;
Fiscal year: 2008: Foreign: 6.
Drugs Program: Prescription drug advertising and labeling;
Fiscal year: 2004: Domestic: 2;
Fiscal year: 2004: Foreign: 0;
Fiscal year: 2005: Domestic: 1;
Fiscal year: 2005: Foreign: 0;
Fiscal year: 2006: Domestic: 0;
Fiscal year: 2006: Foreign: 0;
Fiscal year: 2007: Domestic: 1;
Fiscal year: 2007: Foreign: 0;
Fiscal year: 2008: Domestic: 0;
Fiscal year: 2008: Foreign: 0.
Drugs Program: Quality assurance;
Fiscal year: 2004: Domestic: 1,524;
Fiscal year: 2004: Foreign: 201;
Fiscal year: 2005: Domestic: 1,619;
Fiscal year: 2005: Foreign: 217;
Fiscal year: 2006: Domestic: 1,447;
Fiscal year: 2006: Foreign: 164;
Fiscal year: 2007: Domestic: 1,233;
Fiscal year: 2007: Foreign: 283;
Fiscal year: 2008: Domestic: 1,135;
Fiscal year: 2008: Foreign: 268.
Drugs Program: Unapproved and misbranded drugs;
Fiscal year: 2004: Domestic: 38;
Fiscal year: 2004: Foreign: 0 ;
Fiscal year: 2005: Domestic: 54;
Fiscal year: 2005: Foreign: 0;
Fiscal year: 2006: Domestic: 47;
Fiscal year: 2006: Foreign: 0;
Fiscal year: 2007: Domestic: 34;
Fiscal year: 2007: Foreign: 0;
Fiscal year: 2008: Domestic: 49;
Fiscal year: 2008: Foreign: 0.
Drugs Program: Total;
Fiscal year: 2004: Domestic: 2,241;
Fiscal year: 2004: Foreign: 374;
Fiscal year: 2005: Domestic: 2,322;
Fiscal year: 2005: Foreign: 370;
Fiscal year: 2006: Domestic: 2,061;
Fiscal year: 2006: Foreign: 342;
Fiscal year: 2007: Domestic: 1,817;
Fiscal year: 2007: Foreign: 501;
Fiscal year: 2008: Domestic: 1,772;
Fiscal year: 2008: Foreign: 452.
Biologics program: Blood and blood products;
Fiscal year: 2004: Domestic: 1,706;
Fiscal year: 2004: Foreign: 8;
Fiscal year: 2005: Domestic: 1,613;
Fiscal year: 2005: Foreign: 25;
Fiscal year: 2006: Domestic: 1,462;
Fiscal year: 2006: Foreign: 8;
Fiscal year: 2007: Domestic: 1,398;
Fiscal year: 2007: Foreign: 21;
Fiscal year: 2008: Domestic: 1,314;
Fiscal year: 2008: Foreign: 22.
Biologics program: Human cellular, tissue and gene therapies;
Fiscal year: 2004: Domestic: 351;
Fiscal year: 2004: Foreign: 3;
Fiscal year: 2005: Domestic: 305;
Fiscal year: 2005: Foreign: 1;
Fiscal year: 2006: Domestic: 402;
Fiscal year: 2006: Foreign: 1;
Fiscal year: 2007: Domestic: 458;
Fiscal year: 2007: Foreign: 6;
Fiscal year: 2008: Domestic: 407;
Fiscal year: 2008: Foreign: 5.
Biologics program: Vaccines and allergenic products;
Fiscal year: 2004: Domestic: 38;
Fiscal year: 2004: Foreign: 6;
Fiscal year: 2005: Domestic: 70;
Fiscal year: 2005: Foreign: 14;
Fiscal year: 2006: Domestic: 52;
Fiscal year: 2006: Foreign: 13;
Fiscal year: 2007: Domestic: 79;
Fiscal year: 2007: Foreign: 13;
Fiscal year: 2008: Domestic: 66;
Fiscal year: 2008: Foreign: 23.
Biologics program: Total;
Fiscal year: 2004: Domestic: 2,009;
Fiscal year: 2004: Foreign: 17;
Fiscal year: 2005: Domestic: 1,893;
Fiscal year: 2005: Foreign: 40;
Fiscal year: 2006: Domestic: 1,813;
Fiscal year: 2006: Foreign: 22;
Fiscal year: 2007: Domestic: 1,848;
Fiscal year: 2007: Foreign: 40;
Fiscal year: 2008: Domestic: 1,678;
Fiscal year: 2008: Foreign: 50.
Devices program: Compliance;
Fiscal year: 2004: Domestic: 1,645;
Fiscal year: 2004: Foreign: 293;
Fiscal year: 2005: Domestic: 1,486;
Fiscal year: 2005: Foreign: 225;
Fiscal year: 2006: Domestic: 1,530;
Fiscal year: 2006: Foreign: 209;
Fiscal year: 2007: Domestic: 1,318;
Fiscal year: 2007: Foreign: 268;
Fiscal year: 2008: Domestic: 1,303;
Fiscal year: 2008: Foreign: 208.
Devices program: Mammography Quality Standards Act Authority;
Fiscal year: 2004: Domestic: 444;
Fiscal year: 2004: Foreign: 18;
Fiscal year: 2005: Domestic: 489;
Fiscal year: 2005: Foreign: 16;
Fiscal year: 2006: Domestic: 473;
Fiscal year: 2006: Foreign: 5;
Fiscal year: 2007: Domestic: 417;
Fiscal year: 2007: Foreign: 19;
Fiscal year: 2008: Domestic: 406;
Fiscal year: 2008: Foreign: 14.
Devices program: Postmarket assurance;
Fiscal year: 2004: Domestic: 628;
Fiscal year: 2004: Foreign: 131;
Fiscal year: 2005: Domestic: 642;
Fiscal year: 2005: Foreign: 83;
Fiscal year: 2006: Domestic: 686;
Fiscal year: 2006: Foreign: 82;
Fiscal year: 2007: Domestic: 696;
Fiscal year: 2007: Foreign: 115;
Fiscal year: 2008: Domestic: 749;
Fiscal year: 2008: Foreign: 77.
Devices program: Product evaluation;
Fiscal year: 2004: Domestic: 489;
Fiscal year: 2004: Foreign: 61;
Fiscal year: 2005: Domestic: 448;
Fiscal year: 2005: Foreign: 49;
Fiscal year: 2006: Domestic: 443;
Fiscal year: 2006: Foreign: 74;
Fiscal year: 2007: Domestic: 430;
Fiscal year: 2007: Foreign: 67;
Fiscal year: 2008: Domestic: 373;
Fiscal year: 2008: Foreign: 61.
Devices program: Radiation Control for Health Safety Act Authority;
Fiscal year: 2004: Domestic: 119;
Fiscal year: 2004: Foreign: 24;
Fiscal year: 2005: Domestic: 107;
Fiscal year: 2005: Foreign: 9;
Fiscal year: 2006: Domestic: 85;
Fiscal year: 2006: Foreign: 24;
Fiscal year: 2007: Domestic: 86;
Fiscal year: 2007: Foreign: 10;
Fiscal year: 2008: Domestic: 90;
Fiscal year: 2008: Foreign: 11.
Devices program: Total;
Fiscal year: 2004: Domestic: 2,599;
Fiscal year: 2004: Foreign: 349;
Fiscal year: 2005: Domestic: 2,434;
Fiscal year: 2005: Foreign: 269;
Fiscal year: 2006: Domestic: 2,430;
Fiscal year: 2006: Foreign: 266;
Fiscal year: 2007: Domestic: 2,170;
Fiscal year: 2007: Foreign: 328;
Fiscal year: 2008: Domestic: 2,093;
Fiscal year: 2008: Foreign: 261.
Medical product programs total:
Fiscal year: 2004: Domestic: 6,849;
Fiscal year: 2004: Foreign: 740;
Fiscal year: 2005: Domestic: 6,649;
Fiscal year: 2005: Foreign: 679;
Fiscal year: 2006: Domestic: 6,304;
Fiscal year: 2006: Foreign: 630;
Fiscal year: 2007: Domestic: 5,835;
Fiscal year: 2007: Foreign: 869;
Fiscal year: 2008: Domestic: 5,543;
Fiscal year: 2008: Foreign: 763.
Source: FDA.
Legend: Domestic = domestic inspection; Foreign = foreign inspection.
Note: Individual entries may not sum to program totals because FDA may
conduct more than one type of inspection on the same occasion.
[End of table]
While the number of domestic inspections declined for medical product
programs overall between fiscal year 2004 and fiscal year 2008, FDA
increased the number of foreign inspections it conducted for the drugs
and biologics programs. The total number of foreign inspections
fluctuated from year to year, and in fiscal year 2008, FDA conducted a
total of 763 foreign inspections--23 more than it did in 2004.
* For the drugs program, FDA conducted 374 foreign inspections in
fiscal year 2004 and 452 such inspections in fiscal year 2008--an
increase of 78 inspections.
* For the biologics program, FDA conducted 17 foreign inspections in
fiscal year 2004 and 50 such inspections in fiscal year 2008--an
increase of 33 inspections.
* For the devices program, FDA conducted 349 foreign inspections in
fiscal year 2004 and 261 such inspections in fiscal year 2008--a
decrease of 88 inspections.
Despite increases in the total number of foreign inspections conducted
over this time period, they constituted a small share--12 percent--of
the total number of medical product program inspections in fiscal year
2008. In addition, FDA is only able to reach a small share of the total
number of foreign establishments producing medical products for the
U.S. market. In fiscal year 2008, FDA conducted inspections at 749
foreign establishments, which represented about 7 percent of the 10,158
total foreign medical product establishments registered with the agency
that year.
Trends in Inspection Resources:
FDA conducted 17 percent fewer medical product inspections in fiscal
year 2008 than it did in fiscal year 2004, although Office of
Regulatory Affairs (ORA) funding for these inspections increased 16
percent during this period--from about $101 million to about $117
million. While the total number of medical product inspections FDA
conducted decreased, the agency conducted more foreign inspections over
this time period. FDA estimates that, on average, the cost of a foreign
inspection is more than twice the cost of a domestic inspection. The
agency's increase in foreign inspections may explain why increased
inspection funding supported fewer total inspections.
Although funding for inspections was greater in fiscal year 2008 than
in fiscal year 2004, it did not increase in each of these 5 years for
each medical product program. Funding for the drugs and biologics
program inspections remained relatively constant between fiscal years
2004 and 2005, decreased in fiscal year 2006, and increased in fiscal
years 2007 and 2008. In fiscal year 2008, funding for drugs program
inspections was 1 percent greater than it was in fiscal year 2004, and
funding for biologics program inspections was 8 percent greater than it
was in fiscal year 2004. These rates of increase in funding were
substantially lower than the GDP rate of inflation between fiscal years
2004 and 2008 of 12 percent. For the devices program, funding remained
relatively constant between fiscal years 2004 and 2005, increased in
fiscal years 2006 and 2007, and remained relatively constant between
fiscal years 2007 and 2008. Over this period, funding for devices
program inspections increased 46 percent. (See figure 10.)
Figure 10: Annual Funding Resources for Medical Product Program
Inspections, Fiscal Years 2004 through 2008 (Dollars in millions):
[Refer to PDF for image: stacked line graph]
Fiscal year: 2004;
Devices: $30 million;
Biologics: $22 million;
Drugs: $48 million;
Total: $100 million.
Fiscal year: 2005;
Devices: $32 million;
Biologics: $23 million;
Drugs: $48 million;
Total: $103 million.
Fiscal year: 2006;
Devices: $40 million;
Biologics: $21 million;
Drugs: $43 million;
Total: $104 million.
Fiscal year: 2007;
Devices: $43 million;
Biologics: $23 million;
Drugs: $45 million;
Total: $113 million.
Fiscal year: 2008;
Devices: $44 million;
Biologics: $24 million;
Drugs: $49 million;
Total: $117 million.
Source: FDA.
[End of figure]
Although ORA funding for inspection activities increased between fiscal
year 2004 and fiscal year 2008, the number of ORA full-time equivalent
(FTE) staff devoted to medical product inspections declined 19 percent
during this time period, from 844 FTEs in fiscal year 2004 to 684 FTEs
in fiscal year 2008. Each of the medical product programs experienced a
decline in FTEs conducting inspections during this time period.
Compared to fiscal year 2004 FTE levels, in fiscal year 2008 there were
114 fewer FTEs devoted to drug inspections (a decline of 27 percent),
38 fewer FTEs devoted to biologics inspections (a decline of 19
percent), and 8 fewer FTEs devoted to device inspections (a decline of
4 percent). Most of the decreases in FTEs occurred between fiscal year
2004 and fiscal year 2006. (See figure 11.) Although contractors do not
perform establishment inspections, they may conduct activities that
facilitate these inspections. Because counts of FTEs do not include
contractors, these data do not fully represent FDA's staffing resources
for these activities.
Figure 11: Annual Staffing Resources for Medical Product Program
Inspections, Fiscal Years 2004 through 2008 (Full-time equivalents
[FTE]):
[Refer to PDF for image: stacked line graph]
Fiscal year: 2004;
Devices: 223;
Biologics: 198;
Drugs: 423;
Total: 844.
Fiscal year: 2005;
Devices: 206;
Biologics: 183;
Drugs: 388;
Total: 777.
Fiscal year: 2006;
Devices: 199;
Biologics: 155;
Drugs: 335;
Total: 689.
Fiscal year: 2007;
Devices: 210;
Biologics: 172;
Drugs: 325;
Total: 707.
Fiscal year: 2008;
Devices: 215;
Biologics: 160;
Drugs: 309;
Total: 684.
Source: FDA.
Note: One FTE represents 40 hours of work per week conducted by a
federal government employee over the course of 1 year, and does not
include contractors.
[End of figure]
[End of section]
Appendix V: Trends in FDA's Review of Adverse Event Reports:
From fiscal years 2004 to 2008, the Food and Drug Administration (FDA)
received an increasing number of adverse event reports for marketed
medical products--substantially more reports than staff could review,
according to FDA officials. While the total number of adverse event
reports FDA received increased 81 percent over this time period,
funding increased 154 percent and staffing resources increased 100
percent. Although FDA officials told us they received more adverse
event reports than staff could review, the agency could not provide
data showing the number of adverse event reports staff reviewed during
this time period.
Trends in Reviewing Adverse Event Reports:
From fiscal years 2004 to 2008, FDA received an increasing number of
adverse event reports for marketed medical products. During this time
period the number of drug-related adverse event reports FDA received
increased 23 percent, from 426,016 reports in fiscal year 2004 to
522,871 reports in fiscal year 2008. An even bigger increase occurred
in the receipt of biologic adverse event reports, which increased 86
percent, from 19,569 reports in fiscal year 2004 to 36,410 reports in
fiscal year 2008. FDA saw the highest growth--210 percent--in device-
related adverse event reports, with 189,450 reports received in fiscal
year 2004 and 588,161 reports received in fiscal year 2008. As the
number of adverse event reports for drugs, biologics, and devices grew
between fiscal years 2004 and 2008, the number of reports that FDA
considers to be serious increased 72 percent.
Although FDA officials told us that they place the highest priority in
reviewing serious adverse event reports, agency officials reported that
they receive substantially more adverse event reports than staff can
review. However, FDA could not provide data showing how many adverse
event reports staff have reviewed. According to agency officials, the
drug, biologic, and device adverse event reporting systems used by FDA
do not allow the agency to accurately determine if an individual
adverse event report has been reviewed by staff.
Trends in Resources for Reviewing Adverse Event Reports:
FDA's financial and staffing resources for the review of adverse event
reports associated with the use of marketed medical products have grown
from fiscal years 2004 to 2008. Overall, funding for adverse event
reviews has increased 154 percent during this time period from about
$31 million in fiscal year 2004 to about $78 million in fiscal year
2008. FDA experienced the greatest growth in financial resources for
the review of drug-related adverse event reports with a 215 percent
increase or from about $19 million in fiscal year 2004 to about $60
million in fiscal year 2008. Meanwhile, FDA saw the lowest increase in
funding--53 percent--for the review of device-related adverse event
reports, or from about $10 million in fiscal year 2004 to about $15
million in fiscal year 2008. Funding for adverse event reviews--in
total, and for each program--grew at a rate faster than inflation over
this time period as measured by the gross domestic product (GDP) price
index. See figure 12 for trends in FDA funding for the review of
adverse events related to drugs, biologics, and devices.
Figure 12: Funding for Adverse Event Reviews Related to Drugs,
Biologics, and Devices, Fiscal Years 2004 through 2008:
[Refer to PDF for image: stacked line graph]
Fiscal year: 2004;
Devices: $9.8 million;
Biologics: $1.7 million;
Drugs: $19.2 million;
Total: $30.7 million.
Fiscal year: 2005;
Devices: $12.1 million;
Biologics: $1.8 million;
Drugs: $17.9 million;
Total: $31.8 million.
Fiscal year: 2006;
Devices: $11.1 million;
Biologics: $1.8 million;
Drugs: $19.8 million;
Total: $32.7 million.
Fiscal year: 2007;
Devices: $12.8 million;
Biologics: $2.2 million;
Drugs: $24.9 million;
Total: $39.9 million.
Fiscal year: 2008;
Devices: $15.0 million;
Biologics: $2.6 million;
Drugs: $60.4 million;
Total: $78 million.
Source: FDA.
[End of figure]
Similar to the increase in funding for reviews related to drugs,
biologics, and devices, the number of full-time equivalent (FTE) staff
supporting the review of adverse event reports also increased from
fiscal years 2004 through 2008. The largest growth in FTEs--248 percent
or from 31 FTEs in fiscal year 2004 to 108 FTEs in fiscal year 2008--
was for the review of drug-related adverse event reports. Over the same
period, the number of FTEs for the review of adverse event reports
related to biologics grew 17 percent, from 12 FTEs to 14 FTEs, while
the number of FTEs for the review of device-related adverse event
reports grew 9 percent, from about 40 FTEs to about 43 FTEs. Because
counts of FTEs do not include contractors, these data do not fully
represent FDA's staffing resources for these activities.
With the enactment of the Food and Drug Administration Amendments Act
of 2007 (FDAAA), FDA was able to apply user fees collected through the
Prescription Drug User Fee Act of 1992 (PDUFA), as amended, to support
more postmarket safety activities for drugs, such as the review of
adverse event reports.[Footnote 65] FDA attributes about two-thirds of
the increase in funding and FTEs between fiscal years 2007 and 2008--
142 percent and 40 percent respectively--for the review of drug-related
adverse events to user fee funds.[Footnote 66]
[End of section]
Appendix VI: Trends in FDA's Examination of Advertising and Promotional
Materials:
The Food and Drug Administration (FDA) faced an increasing workload
related to its examination of advertising and promotional materials
between fiscal years 2004 and 2008, particularly for drug-related
promotions. Such promotions constitute the majority of advertising and
promotional materials submitted. While the total number of final drug-
related promotional materials FDA received increased 55 percent over
the period, agency funding for the examination of these materials
increased 167 percent and staff resources increased 26 percent.
Although FDA officials noted that the agency did not have sufficient
resources to examine all drug-related promotional materials submitted
for review, FDA also could not provide information on the number of
such materials staff reviewed.
Trends in Examining Advertising and Promotional Materials:
During fiscal years 2004 through 2008, FDA received an increasing
number of advertising and promotional materials for examination from
manufacturers; however, the agency did not track all of the drug-and
device-related materials that it received or reviewed during this
period. According to FDA officials, the agency was unable to examine
all materials promoting drugs, although we found it did examine nearly
all such materials for biologics. FDA officials also told us that they
review all device-related promotional materials that are submitted.
* Drugs. FDA received an increasing number of advertising and
promotional materials for examination between fiscal year 2004 and
fiscal year 2008, but agency officials told us that staff were unable
to review all materials submitted. FDA received an increasing number of
voluntary draft submissions each year, with 429 submissions in fiscal
year 2004 and 634 submissions in fiscal year 2008.[Footnote 67] In
addition to receiving these voluntary draft submissions, FDA received a
substantially greater and increasing number of final materials that
manufacturers were required to submit. FDA received 45,394 final
materials in fiscal year 2004 and 70,509 final materials in fiscal year
2008--an increase of 55 percent over the time period.[Footnote 68] FDA
officials told us that the agency was unable to examine all of the
promotional materials for drugs it received between fiscal year 2004
and fiscal year 2008 because it lacked the resources to do so. However,
FDA could not provide data on the number of draft or final materials
staff examined during this time.[Footnote 69]
* Biologics. We found that FDA received and examined an increasing
number of draft and final advertising and promotional materials for
biologics products between fiscal year 2006--the first year of
available data-- and fiscal year 2008. Specifically, our review of FDA
data showed that the agency examined all 2,929 draft and final
promotional materials submitted in fiscal year 2006, all 3,256
materials submitted in fiscal year 2007, and all but 17 of 4,480
materials submitted in fiscal year 2008. Most--over 90 percent--of the
total number of materials submitted in each of these years were final
promotional materials.
* Devices. An FDA official told us that the agency received very few
promotional materials for devices between fiscal year 2004 and fiscal
year 2008--device manufacturers are not required to submit these
materials. The official also explained that although all materials
received are examined, FDA could not provide data on the number of
advertising and promotional materials submitted or examined during this
period.
Trends in Resources for Examining Advertising and Promotional
Materials:
Funding for FDA's oversight of drug advertising and promotion increased
167 percent from about $4 million in fiscal year 2004 to about $10
million in fiscal year 2008. Funding for FDA's oversight of biologics
advertising and promotion also increased from $546,000 in fiscal year
2004 to $925,000 in fiscal year 2008. In contrast, funding for the
agency's oversight of devices advertising and promotion decreased from
$590,000 in fiscal year 2004 to $452,000 in fiscal year 2008.
The number of full-time equivalent (FTE) staff supporting FDA's
oversight of drug promotions grew 26 percent from 35 FTEs in fiscal
year 2004 to 44 FTEs in fiscal year 2008. Over this period, the number
of FTEs supporting the agency's oversight of biologics promotions
increased from 4 FTEs to 6 FTEs, while the number of FTEs supporting
the agency's review of devices promotions decreased from 5 FTEs to 4
FTEs. Because counts of FTEs do not include contractors, these data do
not fully represent FDA's staffing resources for these activities.
[End of section]
Appendix VII: Comments from the Department of Health and Human
Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
June 8, 2009:
Marcia Cross:
Director, Health Care:
U.S. Government Accountability Office:
441 G Street N.W.
Washington, DC 20548:
Dear Ms. Cross:
Enclosed are comments on the U.S. Government Accountability Office's
(GAO) report entitled: "Food And Drug Administration: FDA Faced
Challenges Meeting its Growing Medical Product Responsibilities, and
Should Develop Complete Estimates of its Resource Needs" (GAO-09-581).
The Department appreciates the opportunity to review this report before
its publication.
Sincerely,
Signed by:
Barbara Pisaro Clark:
Acting Assistant Secretary for Legislation:
Attachment:
[End of letter]
Department Of Health & Human Services:
Food and Drop Administration:
Silver Spring, MD 20993:
Date: June 5, 2009:
To: Acting Assistant Secretary for Legislation:
From: Principal Deputy Commissioner:
Subject: FDA's General Comments to GAO's Draft Report Entitled. Food and
Drug Administration: FDA Faced Challenges Meeting its Growing Medical
Product Responsibilities, and, Should Develop Complete Estimates of its
Resource Needs (GA0-09-581).
FDA is providing the attached general comments to the U.S. Government
Accountability Office's draft report entitled. Food and Drug
Administration: FDA Faced Challenges Meeting its Growing Medical
Product Responsibilities, and Should Develop Complete Estimates of its
Resource Needs (GAD-09-5811.
FDA appreciates the opportunity to review and comment on this draft
report before it is published.
Signed by:
Josua M. Sharfstein, M.D.
Attachment:
FDA's General Comments on the U.S. Government Accountability Office
(GAO) Draft Report entitled: Food and Drug Administration: FDA Faced
Challenges Meeting its Growing Medical Product Responsibilities, and
Should Develop Complete Estimates of its Resource Needs (GAO-f9-581).
The Food and Drug Administration (FDA) appreciates the opportunity to
review and comment on the Government Accountability Office's (GAO)
draft report. GAO has raised some important issues regarding FDA's
challenges in meeting its medical product responsibilities. The FY 2010
President's Budget for FDA includes an overall increase of $240 million
for FDA's medical product activities. Nearly $120 million of that is in
increased budget authority for safer medical products, including human
and veterinary drug safety. the safety of medical devices, and
biological products including blood, tissue and vaccine safety. file
budget also proposes new user fees for generic drugs (+$36 million) and
for reinspection fees (+10.6 million). These user fees are in addition
to a $74.3 million increase in current law user fees supporting FDA
medical product programs.
The increases will support a life-cycle approach to safety, which
starts at product development and pre-approval testing, through
approval, and post-approval safety surveillance. The additional funding
also provides for increased inspections to improve the safety of the
supply chain, and supports implementation of requirements included in
the FDA Amendments Act.
FDA offers the following responses to the GAO recommendations:
Recommendation 1:
Conduct a comprehensive assessment of the Agency's staffing resources,
including its contractor workforce.
FDA Response:
The FDA agrees that a comprehensive assessment of-its staffing
resources would provide useful information. The agency has in place a
staffing assessment process that has been used for assessing needs for
new staffing and back fills. This assessment has been conducted over
the last 18 months for FDA's Hiring Surges (Phase I and It). FDA will
expand this process to include both contractor workforce and existing
staff. FDA will also utilize this process to plan and assess future
agency staffing needs.
Recommendation 2:
Gather data on the work the agency conducts to fulfill its
responsibilities.
FDA Response:
The FDA plans to conduct a complete inventory of all regulatory work
products by Center.
Recommendation 3:
Assess the extent to which the agency is meeting its responsibilities.
FDA Response:
Along with the inventory of work products generated in response to
recommendation 2 above, FDA will identify and implement relevant
measures for agency programs and offices which will allow FDA to
determine how effectively the agency is meeting its responsibilities.
Many measures of productivity are already in place in conjunction with
user lees and related performance indicators. The data collected and
analyzed for these metrics will he used to inform FDA management about
the effectiveness of specific programs in meeting the agency's
responsibilities and inform management about whether or not changes to
specific programs should be made.
Recommendation 4:
Develop an evidence-based estimate of the resources needed to fulfill
all of its responsibilities.
FDA Response:
In addition to implementing performance management through the use of
metrics across agency offices and programs the agency plans to link
these metrics to its budget and funding allocation. this approach will
inform the agency about how well it is allocating its resources and
what additional resources it needs to fulfill its responsibilities.
[End of section]
Appendix VIII: GAO Contact and Staff Acknowledgments:
GAO Contact:
Marcia Crosse, (202) 512-7114, crossem@gao.gov:
Staff Acknowledgments:
In addition to the contact named above, Geri Redican-Bigott, Assistant
Director; Kye Briesath; Cathy Hamann; Rebecca Hendrickson; Richard
Lipinski; Emily Loriso; Kevin Milne; Lisa Motley; and Patricia Roy made
key contributions to this report.
[End of section]
Related GAO Products:
Information Technology: FDA Needs to Establish Key Plans and Processes
for Guiding Systems Modernization Efforts. [hyperlink,
http://www.gao.gov/products/GAO-09-523]. June 2, 2009.
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-09-271]. Washington, D.C.: January
2009.
Food Safety: Improvements Needed in FDA Oversight of Fresh Produce.
[hyperlink, http://www.gao.gov/products/GAO-08-1047]. Washington, D.C.:
September 26, 2008.
Drug Safety: Better Data Management and More Inspections Are Needed to
Strengthen FDA's Foreign Drug Inspection Program. [hyperlink,
http://www.gao.gov/products/GAO-08-970]. Washington, D.C.: September
22, 2008.
Food Labeling: FDA Needs to Better Leverage Resources, Improve
Oversight, and Effectively Use Available Data to Help Consumers Select
Healthy Foods. [hyperlink, http://www.gao.gov/products/GAO-08-597].
Washington, D.C.: September 9, 2008.
Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-
Label Uses. [hyperlink, http://www.gao.gov/products/GAO-08-835].
Washington, D.C.: July 28, 2008.
Medical Devices: FDA Faces Challenges in Conducting Inspections of
Foreign Manufacturing Establishments. [hyperlink,
http://www.gao.gov/products/GAO-08-780T]. Washington, D.C.: May 14,
2008.
New Drug Development: Science, Business, Regulatory, and Intellectual
Property Issues Cited as Hampering Drug Development Efforts.
[hyperlink, http://www.gao.gov/products/GAO-07-49]. Washington, D.C.:
November 17, 2006.
Food and Drug Administration: Effect of User Fees on Drug Approval
Times, Withdrawals, and Other Agency Activities. [hyperlink,
http://www.gao.gov/products/GAO-02-958]. Washington, D.C.: September
17, 2002.
FDA Resources: Comprehensive Assessment of Staffing, Facilities, and
Equipment Needed. [hyperlink,
http://www.gao.gov/products/GAO/HRD-89-142]. Washington, D.C.:
September 15, 1989.
[End of section]
Footnotes:
[1] GAO, FDA Resources: Comprehensive Assessment of Staffing,
Facilities, and Equipment Needed, [hyperlink,
http://www.gao.gov/products/GAO/HRD-89-142] (Washington, D.C.: Sept.
15, 1989).
[2] Biologics are derived from living sources (such as humans, animals,
and microorganisms), unlike drugs, which are chemically synthesized.
Biologics include blood, vaccines, allergenic products, certain
tissues, and cellular and gene therapies. 42 U.S.C. § 262(i).
[3] Medical devices include instruments, apparatuses, machines, and
implants that are intended for use to diagnose, cure, treat, or prevent
disease, or to affect the structure or any function of the body. 21
U.S.C. § 321(h).
[4] FDA considers oversight of animal drugs and feeds, and research
conducted by FDA's National Center for Toxicological Research, among
its medical product responsibilities. We have excluded these efforts
from the definition of medical product oversight used in this report.
[5] For example, see Statement of Michael A. Friedman, FDA Deputy
Commissioner for Operations, before the Committee on Labor and Human
Resources, United States Senate (Washington, D.C.: Mar. 19, 1997);
Statement of Jane E. Henney, FDA Commissioner, before the Subcommittee
on Oversight and Investigations, Committee on Commerce, House of
Representatives (Washington, D.C.: Oct. 3, 2000); and FDA, FDA's
Growing Responsibilities for the Year 2001 and Beyond (Rockville, Md.:
June 13, 2001).
[6] FDA's Science Board, an advisory board to the FDA commissioner,
provides advice on, among other things, specific complex and technical
issues as well as emerging issues within the scientific community, in
industry, and in academia. See FDA Science Board, Subcommittee on
Science and Technology, FDA Science and Mission at Risk (Rockville,
Md.: November 2007).
[7] U.S. Department of Health and Human Services, Agency Financial
Report: Fiscal Year 2007 (Washington, D.C.: Nov. 15, 2007), and U.S.
Department of Health and Human Services, Agency Financial Report:
Fiscal Year 2008 (Washington, D.C.: Nov. 17, 2008).
[8] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009).
[9] The GDP price index for nondefense goods and services measures the
change in the value of nondefense related goods and services produced
by the U.S. economy in a given period.
[10] In prior reports we found that FDA's establishment registration
databases contain inaccurate information on the number of
establishments manufacturing drugs and devices. However, these data
represent the best information available and are what FDA relies on to
manage its inspection activities. For more information about these
databases, see GAO, Drug Safety: Better Data Management and More
Inspections Are Needed to Strengthen FDA's Foreign Drug Inspection
Program, [hyperlink, http://www.gao.gov/products/GAO-08-970]
(Washington, D.C.: Sept. 22, 2008); and Medical Devices: FDA Faces
Challenges in Conducting Inspections of Foreign Manufacturing
Establishments, [hyperlink, http://www.gao.gov/products/GAO-08-780T]
(Washington, D.C.: May 14, 2008).
[11] Adverse event is the term used by FDA to refer to any untoward
medical event associated with the human use of a medical product.
[12] FDA did not have statutory requirements or performance goals
related to its work in the other two key areas we reviewed--review of
adverse event reports and examination of advertising and promotional
materials--for all medical products during the entire period, fiscal
years 2004 through 2008. For these two areas, we limited our
examination to reviewing trends in the amount of work FDA conducted.
[13] See, for example, [hyperlink,
http://www.gao.gov/products/GAO-08-970].
[14] For additional information on the elements of reliable cost
estimates, see GAO, GAO Cost Estimating and Assessment Guide: Best
Practices for Developing and Managing Capital Program Costs,
[hyperlink, http://www.gao.gov/products/GAO-09-3SP] (Washington, D.C.:
March 2009).
[15] FDA's funding from user fees represents the maximum amount the
agency is authorized to collect from industry, as provided in advance
in appropriations acts.
[16] In this report, we will use the terms "user fee funding" to
describe amounts derived from user fee collections and "fiscal year
appropriations" to describe amounts derived from the General Fund of
the Treasury to delineate the source of the appropriated amounts.
[17] FDA uses the term "budget authority" to refer to its fiscal year
appropriations. Budget authority is, however, the authority provided by
federal law to enter into financial obligations that will result in
immediate or future outlays involving federal government funds. See
GAO, A Glossary of Terms Used in the Federal Budget Process,
[hyperlink, http://www.gao.gov/products/GAO-05-734SP] (Washington,
D.C.: September 2005). Thus, user fees made available through annual
appropriations acts also constitute budget authority.
[18] The remaining portion of FDA's resources--about $1,055 million,
which includes about $970 million in fiscal year appropriations and
about $80 million in user fee funding--supported the agency's other
programs, including FDA's Foods Program, Animal Drugs and Feeds
Program, the National Center for Toxicological Research, the Office of
the Commissioner, and rent and facilities.
[19] Discretionary spending generally refers to outlays from budget
authority that is provided in and controlled by appropriations acts.
Mandatory spending refers to budget authority that is provided in and
controlled by laws other than appropriations acts.
[20] The Mammography Quality Standards Act of 1992 authorized FDA to
collect user fees from mammography facilities to fully cover the cost
of inspections conducted to determine facilities' compliance with
established quality standards for performing mammograms. Pub. L. No.
102-539, 106 Stat. 3547 (codified as amended at 42 U.S.C. § 263b).
[21] Pub. L. No. 102-571, 106 Stat. 4491. PDUFA has been amended and
reauthorized several times since enactment, most recently in 2007.
References to PDUFA in this report refer to PDUFA as amended, except
where otherwise indicated.
[22] Pub. L. No. 107-250, 116 Stat. 1588. MDUFMA has been amended and
reauthorized several times since enactment, most recently in 2007.
References to MDUFMA in this report refer to MDUFMA as amended, except
where otherwise indicated.
[23] The list of agency activities receiving, and excluded from
receiving, user fee funding has changed over time. From fiscal years
1999 through 2002, medical product program activities funded with user
fees included program activities related to the premarket review of new
drugs and biologics as well as inspections of certain mammography
facilities. Activities not funded by user fees during this period
included, for example, the agency's oversight of the safety of
transfusion-related blood products and human tissues; review of
applications for generic drugs, over-the-counter drugs and new devices;
inspections unrelated to the agency's review of an application for a
new drug or new biologic; oversight of the advertising and promotion of
medical products; oversight of the safety of marketed medical products,
including the agency's review of adverse event reports; as well as
agency research and policy development unrelated to the review of new
drugs and new biologics. Beginning in fiscal year 2003, user fee
activities also included those related to the review of device
applications, including the evaluation of postmarket studies and safety
and effectiveness information for certain devices, and the review of
safety information, including adverse event reports, for drugs approved
after October 1, 2002. And, beginning in fiscal year 2008, FDA is
authorized to apply PDUFA user fee funding to more postmarket safety
activities for drugs, including the agency's review of adverse event
reports for these products, regardless of approval date. See 21 U.S.C.
§§ 379g, 379h, 379i, 379j.
[24] Current law permits FDA to apply user fee funding only to defray
increases in the costs of resources allocated to the process of
reviewing new drug and new biologic applications over the costs for
fiscal year 1997, adjusted for inflation, within certain limits; and
current law permits FDA to apply user fee funding only to defray
increases in the costs of resources allocated to the review of device
applications over the costs for fiscal year 2002, adjusted for
inflation. Unlike PDUFA and MDUFMA, user fees collected under the
Mammography Quality Standards Act were designed to fully cover the cost
of inspections conducted, and FDA is not required to use its fiscal
year appropriations to support the cost of these inspections. See 21
U.S.C. §§ 379h(g)(2)(ii), 379j(h)(2)(ii); 42 U.S.C. § 263b.
[25] In fiscal year 2004, responsibility for overseeing some
therapeutic biologics was transferred from CBER to CDER. Examples of
products transferred to CDER include monoclonal antibodies and proteins
intended for therapeutic use. CBER retained responsibility for other
biologics including blood, vaccines, and human tissues.
[26] Sponsors may provide additional information to FDA in reply to a
clinical hold. FDA, in turn, is responsible for reviewing this
information and issuing a written response, known as a response to a
clinical hold.
[27] 21 U.S.C. § 355.
[28] 21 C.F.R. § 355(j). The application for generic drugs is
abbreviated because FDA does not require sponsors to conduct or provide
evidence from clinical trials that are required of developers of new
drugs.
[29] For example, class I (low-risk) devices include tongue depressors,
elastic bandages, reading glasses, and forceps; class II (medium-risk)
devices include electrocardiographs, powered bone drills, and mercury
thermometers; and class III (high-risk) devices include pacemakers and
replacement heart valves. See 21 U.S.C. § 360c.
[30] 21 U.S.C. § 360(k). Most class I devices are exempt from premarket
review requirements. 21 U.S.C. § 360(l). Some class II devices are also
in this exempt category.
[31] 21 U.S.C. § 355.
[32] Each reauthorization of PDUFA was accompanied by new performance
goals for various aspects of the drug review process, as set by the
Secretary of HHS.
[33] These requirements relate to standards for storage of and
manufacturing of medical products. See 21 C.F.R. pts. 210, 211, 606,
820, and 1271 (2008).
[34] 21 U.S.C. § 360(h). FDA is required to inspect domestic
establishments that manufacture class III and class II devices every 2
years. There is no comparable statutory requirement for the inspection
of establishments manufacturing class I devices, and FDA does not
routinely inspect them.
[35] 21 U.S.C. § 381.
[36] See 21 C.F.R. §§ 310.305, 312.32, 314.80 (2008) (drugs); 21 C.F.R.
§§ 312.32, 600.80, 1271.350 (2008) (biologics); 21 C.F.R. pt. 803
(2008) (devices).
[37] See 21 U.S.C. § 352(a), (n), (q), (r); 21 C.F.R. § 202.1(e)(5)(i)
(2008). The Federal Trade Commission oversees the advertising and
promotion of over-the-counter drugs and some devices. See 15 U.S.C. §§
52-55. According to FDA, devices whose advertisements are regulated by
the Federal Trade Commission include most class I and II devices, and
some class III devices.
[38] 21 C.F.R. § 202.1(e) (2008); see also 21 C.F.R. §§ 201.100(c)(1),
201.128 (2008). By law, advertisements for certain devices must include
a brief statement of warnings, precautions, side effects, and
contraindications. 21 U.S.C. § 352(r).
[39] 21 C.F.R. §§ 314.81(b)(3)(i), 601.12(f)(4) (2008).
[40] For information on trends in FDA's food safety resources, see GAO,
Food Safety: Improvements Needed in FDA Oversight of Fresh Produce,
[hyperlink, http://www.gao.gov/products/GAO-08-1047] (Washington, D.C.:
Sept. 26, 2008). For information on trends in FDA's information
technology resources, see GAO, Information Technology: FDA Needs to
Establish Key Plans and Processes for Guiding Systems Modernization
Efforts, [hyperlink, http://www.gao.gov/products/GAO-09-523]
(Washington, D.C.: June 2, 2009).
[41] Our analysis of HHS and federal government funding reflects these
entities' fiscal year 2008 funding, which includes funding for
discretionary and mandatory programs.
[42] In fiscal year 1999, because MDUFMA was not yet enacted, FDA's
user fee activities were related to the agency's premarket review of
new drugs and new biologics, as well as inspections of certain
mammography facilities. By fiscal year 2008, FDA's user fee activities
also included the agency's premarket review of certain devices, some
postmarket activities for certain devices, and some postmarket
activities for drugs.
[43] Between fiscal years 1999 and 2008, CDER, CBER, and CDRH funding
for user fee activities grew 223 percent while the centers' funding for
other center activities not funded with user fees grew 16 percent--less
than the GDP inflation rate (25 percent) over this period. Medical
product program field funding for user fee activities increased 69
percent over this period while funding for other field activities
increased 41 percent.
[44] We have previously reported that FDA's user fees have the effect
of limiting the resources available to other activities not funded with
user fees. See GAO, Food and Drug Administration: Effect of User Fees
on Drug Approval Times, Withdrawals, and Other Agency Activities,
[hyperlink, http://www.gao.gov/products/GAO-02-958] (Washington, D.C.:
Sept. 17, 2002).
[45] FTEs do not include contractors and therefore provide a partial
measure of staffing resources.
[46] In late fiscal year 2008, FDA began a major multiyear initiative
to hire individuals with science and medical backgrounds. Some of the
increase in FTEs in fiscal year 2008 may be attributed to this
initiative.
[47] In particular, CDRH and ORA estimated that their use of
contractors increased over the time period, while CDER and CBER
estimated that their use of contractors remained steady.
[48] To obtain an estimate of the number of contractors working with
FDA's medical product programs, we reviewed HHS' online employee
directory. As of March 2009, this directory listed over 700 contractors
as working with CDER, CBER, CDRH, and ORA. However, one contractor is
not comparable to one FTE because each contractor may not work the
equivalent of 40 hours each week over the course of 1 year, which is
the definition of an FTE. In addition, the HHS directory may not
include a current or complete list of contractors and does not provide
a list of contractors from prior years. We did not verify the accuracy
of information provided by the directory.
[49] FDA officials confirmed that these 11 laws increased the agency's
medical product oversight responsibilities. While these laws imposed
requirements on FDA expressly, other laws enacted between fiscal years
1999 and 2008 also added to FDA's medical product responsibilities. For
example, the Pandemic and All-Hazards Preparedness Act was enacted in
December 2006 to improve the nation's public health and medical
preparedness and response capabilities for emergencies. While not
expressly directed at FDA, agency officials noted that this act
included provisions that added to their medical product
responsibilities. Our review did not identify any laws enacted in 1999,
2000, 2001, or 2008 that specifically affected FDA's medical product
responsibilities.
[50] Pub. L. No. 107-250, 116 Stat. 1588.
[51] The term reprocessed, with respect to a single-use device, means
an original single-use device that has previously been used on a
patient and has been subjected to additional processing and
manufacturing for the purpose of an additional single use on a patient.
21 U.S.C. § 321(ll)(2).
[52] Pub. L. No. 108-155, 117 Stat. 1936.
[53] Pub. L. No. 110-85, 121 Stat. 823.
[54] Prior to the enactment of FDAAA, FDA only had the authority in
limited circumstances to require sponsors to conduct a study once a
drug or biologic had been approved for marketing in the United States.
[55] According to FDA officials, the agency does not maintain
information on the number of advertising and promotional materials that
it receives for devices. FDA does not require manufacturers to submit
advertising and promotional materials for devices at the time of
initial dissemination.
[56] Data for the number of meeting requests from industry officials
regarding devices was not available from FDA for fiscal years 1999
through 2004. From fiscal years 2005 to 2008, FDA saw a 28 percent
increase in the number of meetings requested from device sponsors, or
144 more meeting requests.
[57] This decrease was mostly due to a decrease in the number of
domestic establishments registered to produce devices. FDA officials
told us that the number of domestic establishments manufacturing
devices in fiscal year 1999 may have been inflated, and that the lower
number of such establishments reported for fiscal year 2008 may be
related to changes FDA made to its device establishment registration
system during that time. FDA officials found that the changes resulted
in a smaller, more accurate listing of establishments manufacturing
devices in fiscal year 2008. See GAO-08-780T.
[58] Fiscal year 2008 data are as of November 2008.
[59] FDA has requested authorization to collect user fees from industry
and use the amounts collected to support its review of ANDAs. In its
fiscal year 2009 budget justification, FDA explained it would need an
additional $15 million and 34 FTEs from user fees to support its review
of these applications, noting that these resources would enable the
agency to reduce the time it takes to review ANDAs and respond to the
growing number of applications submitted.
[60] We also previously reported that FDA cannot be certain that it is
reviewing the highest-priority materials or that violative materials
are not being circulated. See GAO, Prescription Drugs: FDA's Oversight
of the Promotion of Drugs for Off-Label Uses, [hyperlink,
http://www.gao.gov/products/GAO-08-835] (Washington, D.C.: July 28,
2008).
[61] One FTE represents 40 hours of work per week conducted by a
federal government employee over the course of 1 year, and does not
include contractors.
[62] The number of ANDAs FDA reviewed exceeds the number of original
ANDAs received in a particular year because FDA may have completed its
review of original ANDAs submitted during prior years, or may have
reviewed resubmitted applications.
[63] The number of NDAs and BLAs submitted to FDA is significantly less
than the number of active INDs. We previously reported data from the
Pharmaceutical Research and Manufacturers of America showing that only
one of every five new drugs successfully completes clinical testing.
See GAO, New Drug Development: Science, Business, Regulatory, and
Intellectual Property Issues Cited as Hampering Drug Development
Efforts, [hyperlink, http://www.gao.gov/products/GAO-07-49]
(Washington, D.C.: Nov. 17, 2006).
[64] FDA tracks inspections in categories that reflect either
inspection type or product type. For the drugs and devices programs,
FDA tracks the number of inspections conducted based on inspection
type. The types of inspections conducted for the drugs program include
bioresearch monitoring, new drug evaluation, and postmarket
surveillance, and the types of inspections conducted for the devices
program include product evaluation, compliance, and postmarket
assurance. FDA does not track biologics program inspections based on
inspection type. Instead, the agency tracks the number of inspections
conducted for the biologics program by product type--for example, blood
and blood products, and vaccines and allergenic products.
[65] FDA's authority to apply user fees collected under the Medical
Device User Fee and Modernization Act of 2002, as amended, to
postmarket safety activities for devices is limited to the evaluation
of postmarket studies and safety and effectiveness information for
certain devices.
[66] Along with authorizing FDA to use PDUFA funding for more
postmarket safety activities, FDAAA also increased the actions FDA must
take to meet its responsibility to ensure the safety of marketed drugs
by requiring FDA to biweekly screen its system for adverse events and
issue quarterly reports of new safety information or potential signals
of serious risk associated with the use of a drug.
[67] FDA received a total of 2,709 draft submissions over the 5-year
period. Draft submissions may be comprised of many submitted materials--
for example, one submission may include multiple brochures. As we
previously reported, FDA does not maintain data on the number of
materials received. See GAO, Prescription Drugs: FDA's Oversight of the
Promotion of Drugs for Off-Label Uses, [hyperlink,
http://www.gao.gov/products/GAO-08-835] (Washington, D.C.: July 28,
2008).
[68] FDA received a total of nearly 300,000 final drug-related
promotional materials between fiscal year 2004 and fiscal year 2008.
[69] FDA does track the number of letters it issues in response to the
draft promotional materials that staff examined. However, these letters
may encompass issues from multiple submitted materials, and the agency
does not issue a letter for every draft promotional material examined.
Between fiscal year 2004 and fiscal year 2008, FDA sent a total of
2,262 letters in response to its examination of draft promotional
materials, and the number of letters issued decreased 44 percent during
this period.
[End of section]
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