Prescription Drugs
Trends in FDA's Oversight of Direct-to-Consumer Advertising Gao ID: GAO-08-758T May 8, 2008The Food and Drug Administration (FDA) is responsible for overseeing direct-to-consumer (DTC) advertising of prescription drugs, which includes a range of media, such as television, magazines, and the Internet. If FDA identifies a violation of laws or regulations in a DTC advertising material, the agency may issue a regulatory letter asking the drug company to take specific actions. In 2002, GAO reported on delays in FDA's issuance of regulatory letters. GAO was asked to discuss trends in FDA's oversight of DTC advertising and the actions FDA has taken when it identifies violations. This statement is based on GAO's 2006 report, Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising, GAO-07-54 (November 16, 2006). In this statement, GAO discusses the (1) DTC advertising materials FDA reviews, (2) FDA's process for issuing regulatory letters citing DTC advertising materials and the number of letters issued, and (3) the effectiveness of FDA's regulatory letters at limiting the dissemination of false or misleading DTC advertising. For its 2006 report, GAO examined FDA data on the advertising materials the agency received and reviewed the regulatory letters it issued citing prescription drug promotion from 1997 through 2005. For this statement, GAO also reviewed data from FDA to update selected information from the 2006 report.
Since 1999, FDA has received a steadily increasing number of advertising materials directed to consumers. In 2006, GAO found that FDA reviewed a small portion of the DTC materials it received, and the agency could not ensure that it was identifying for review the materials it considered to be highest priority. While FDA officials told GAO that the agency prioritized the review of materials that had the greatest potential to negatively affect public health, the agency had not documented criteria to make this prioritization. GAO recommended that FDA document and systematically apply criteria for prioritizing its reviews of DTC advertising materials. In May 2008, FDA indicated that it had documented criteria to prioritize reviews. However, FDA still does not systematically apply its criteria to all of the DTC materials it receives. Furthermore, GAO noted in its 2006 report that FDA could not determine whether a particular material had been reviewed. GAO recommended in that report that the agency track which DTC materials had been reviewed. FDA officials indicated to GAO in May 2008 that the agency still did not track this information. As a result, the agency cannot ensure that it is identifying and reviewing the highest-priority materials. GAO found in 2006 that, since a 2002 policy change requiring legal review of all draft regulatory letters, FDA's process for drafting and issuing letters was taking longer and the agency was issuing fewer letters per year. FDA officials told GAO that the policy change contributed to the lengthened review. In 2006, GAO found that the effectiveness of FDA's regulatory letters at halting the dissemination of violative DTC materials had been limited. By the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter. In addition, FDA's issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.
GAO-08-758T, Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer Advertising
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Testimony:
Before the Subcommittee on Oversight and Investigations, Committee on
Energy and Commerce, House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 10:00 a.m. EDT:
Thursday, May 8, 2008:
Prescription Drugs:
Trends in FDA's Oversight of Direct-to-Consumer Advertising:
Statement of Marcia Crosse:
Director, Health Care:
GAO-08-758T:
GAO Highlights:
Highlights of GAO-08-758T, a testimony before the Subcommittee on
Oversight and Investigations, Committee on Energy and Commerce, House
of Representatives.
Why GAO Did This Study:
The Food and Drug Administration (FDA) is responsible for overseeing
direct-to-consumer (DTC) advertising of prescription drugs, which
includes a range of media, such as television, magazines, and the
Internet. If FDA identifies a violation of laws or regulations in a DTC
advertising material, the agency may issue a regulatory letter asking
the drug company to take specific actions. In 2002, GAO reported on
delays in FDA‘s issuance of regulatory letters.
GAO was asked to discuss trends in FDA‘s oversight of DTC advertising
and the actions FDA has taken when it identifies violations. This
statement is based on GAO‘s 2006 report, Prescription Drugs:
Improvements Needed in FDA‘s Oversight of Direct-to-Consumer
Advertising, GAO-07-54 (November 16, 2006). In this statement, GAO
discusses the (1) DTC advertising materials FDA reviews, (2) FDA‘s
process for issuing regulatory letters citing DTC advertising materials
and the number of letters issued, and (3) the effectiveness of FDA‘s
regulatory letters at limiting the dissemination of false or misleading
DTC advertising.
For its 2006 report, GAO examined FDA data on the advertising materials
the agency received and reviewed the regulatory letters it issued
citing prescription drug promotion from 1997 through 2005. For this
statement, GAO also reviewed data from FDA to update selected
information from the 2006 report.
What GAO Found:
Since 1999, FDA has received a steadily increasing number of
advertising materials directed to consumers. In 2006, GAO found that
FDA reviewed a small portion of the DTC materials it received, and the
agency could not ensure that it was identifying for review the
materials it considered to be highest priority. While FDA officials
told GAO that the agency prioritized the review of materials that had
the greatest potential to negatively affect public health, the agency
had not documented criteria to make this prioritization. GAO
recommended that FDA document and systematically apply criteria for
prioritizing its reviews of DTC advertising materials. In May 2008, FDA
indicated that it had documented criteria to prioritize reviews.
However, FDA still does not systematically apply its criteria to all of
the DTC materials it receives. Furthermore, GAO noted in its 2006
report that FDA could not determine whether a particular material had
been reviewed. GAO recommended in that report that the agency track
which DTC materials had been reviewed. FDA officials indicated to GAO
in May 2008 that the agency still did not track this information. As a
result, the agency cannot ensure that it is identifying and reviewing
the highest-priority materials.
GAO found in 2006 that, since a 2002 policy change requiring legal
review of all draft regulatory letters, FDA‘s process for drafting and
issuing letters was taking longer and the agency was issuing fewer
letters per year. FDA officials told GAO that the policy change
contributed to the lengthened review.
In 2006, GAO found that the effectiveness of FDA‘s regulatory letters
at halting the dissemination of violative DTC materials had been
limited. By the time the agency issued regulatory letters, drug
companies had already discontinued use of more than half of the
violative advertising materials identified in each letter. In addition,
FDA‘s issuance of regulatory letters had not always prevented drug
companies from later disseminating similar violative materials for the
same drugs.
To view the full product, including the scope and methodology, click on
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-08-758T]. For more
information, contact Marcia Crosse, (202) 512-7114, crossem@gao.gov
[End of section]
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today as you examine the practice of direct-to-
consumer (DTC) advertising of prescription drugs, which includes a
range of media, such as television, magazines, and the Internet. The
Department of Health and Human Services' (HHS) Food and Drug
Administration (FDA) regulates the promotion and advertising of
prescription drugs, including DTC materials, to ensure they are not
false or misleading and otherwise comply with applicable laws and
regulations. This oversight function is carried out by FDA's Division
of Drug Marketing, Advertising, and Communications (DDMAC). Recently,
you have raised concerns regarding potentially misleading DTC
advertising for several drugs.
FDA regulations require that drug companies submit final DTC
advertising materials to FDA at the time they are first disseminated to
the public.[Footnote 1] In addition, although generally not required to
do so, drug companies may voluntarily submit draft versions of DTC
advertising materials to FDA for advisory comments.[Footnote
2],[Footnote 3] If FDA identifies a violation in a disseminated DTC
advertisement, such as a false or misleading safety or effectiveness
claim, the agency may issue a regulatory letter. In these letters, FDA
asks drug companies to take specific actions, such as stopping the
dissemination of the advertisement and, if FDA finds the violation to
be particularly serious, running another advertisement to correct
misleading impressions left by the violative advertisement. DDMAC
drafts these regulatory letters, which are then reviewed and approved
by the agency's Office of Chief Counsel (OCC). In October 2002, we
reported on delays in FDA's issuance of these regulatory letters and
recommended that the agency take action to reduce the amount of time
for internal review of draft regulatory letters citing violations in
DTC materials.[Footnote 4] In response to our recommendation, FDA
agreed to take steps to reduce the time to issue regulatory letters.
My remarks today are primarily based on our November 2006 report on
trends in FDA's oversight of DTC advertising and the actions it took
when it identified a violation in a disseminated DTC
advertisement.[Footnote 5] Today, I will discuss (1) the DTC
advertising materials FDA reviews, (2) FDA's process for issuing
regulatory letters citing DTC advertising materials and the number of
letters issued, and (3) the effectiveness of FDA's regulatory letters
at limiting the dissemination of false or misleading DTC advertising.
For our November 2006 report, to examine the DTC advertising materials
that FDA reviewed, we obtained data from FDA on the number and type of
advertising materials that it received and reviewed from 1997 through
2005. To examine FDA's process for issuing regulatory letters that
cited violative DTC advertising materials and the number of such
letters that FDA issued, we reviewed all regulatory letters issued by
FDA from 1997 through 2005. To examine the effectiveness of these
regulatory letters, we reviewed their content to identify violations
cited; we did not evaluate the appropriateness or legal sufficiency of
these letters. In addition, we obtained information from FDA about the
timeliness of the letters issued in 2004 and 2005 and drug companies'
compliance with any corrective action requested by FDA. For this
statement, we reviewed data from FDA to update selected information
from our 2006 report. We shared the updated facts contained in this
statement with FDA officials. They provided technical comments which we
incorporated as appropriate. We conducted the work for our November
report from January 2006 through November 2006 and for this statement
from April 2008 through May 2008. We conducted all of our work 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.
In summary, in our 2006 report we found that FDA reviewed a small
portion of the DTC materials it received, and the agency could not
ensure that it identified for review the materials it considered to be
highest priority. We found that the number of final DTC materials FDA
received each year had almost doubled from 2002 through 2005. Since
2006, the number of materials received by FDA has continued to
increase. While FDA officials told us that the agency prioritized the
review of materials that had the greatest potential to negatively
affect public health, we found that the agency had not documented
criteria to make this prioritization. Rather, FDA officials identified
informal criteria that reviewers considered when identifying materials
for review. We recommended that FDA document and systematically apply
criteria for prioritizing its reviews of DTC advertising materials. We
also noted in our 2006 report that FDA could not determine whether a
particular material had been reviewed. Therefore, we recommended in our
2006 report that the agency track which DTC materials have been
reviewed. In May 2008, FDA informed us that it now had documented
criteria to prioritize reviews. However, FDA still does not
systematically apply its criteria to all of the DTC materials it
receives to determine which are highest priority for review. FDA
officials also indicated to us in May 2008 that the agency still does
not track whether a particular material has been reviewed. As a result,
the agency cannot ensure that it is identifying and reviewing the
highest-priority materials.
Since a 2002 policy change requiring internal legal review of all draft
regulatory letters, FDA's process for drafting and issuing letters has
taken longer and the agency issued fewer letters per year. Prior to
this policy change, from 1997 through 2001, it took FDA an average of 2
weeks to issue a letter. After the change, from 2002 through 2005, once
the agency began drafting a regulatory letter for violative DTC
materials, it took an average of 4 months to issue the letter. In 2006
and 2007, the time increased to an average of over 5 months. FDA
officials told us that the policy change contributed to the lengthened
review by creating additional levels of review and making it necessary
for the DDMAC reviewers who draft the regulatory letters to do
substantially more work to prepare for and respond to comments from
OCC. After the policy change, FDA issued about half as many regulatory
letters that cited violative DTC advertisements per year--between 8 and
11 letters annually from 2002 through 2005, compared with 15 to 25
letters annually from 1997 through 2001. FDA issued 4 such letters in
2006 and 2 in 2007. FDA officials told us that the agency issued
letters only for the violative DTC materials that it considered the
most serious and most likely to negatively affect consumers' health.
At the time of our 2006 report, we found that the effectiveness of
FDA's regulatory letters at halting the dissemination of violative DTC
materials had been limited. FDA issued 19 such regulatory letters from
2004 through 2005. On average, it issued these letters 8 months after
the violative materials were first disseminated. By the time these
regulatory letters were issued, drug companies had already discontinued
more than half of the violative advertisements. Generally, companies
complied with FDA requests to remove cited materials that were still
being disseminated, and those companies requested to issue corrective
materials did so, but not until 5 months or more after the regulatory
letter was issued. FDA's issuance of regulatory letters did not always
prevent drug companies from later disseminating similar violative
materials for the same drugs. We found that of the 89 drugs for which
FDA cited violative DTC materials from 1997 through 2005, 25 drugs had
DTC materials cited in more than one regulatory letter, sometimes for
similar types of violations. Delays in issuing regulatory letters limit
FDA's effectiveness in overseeing DTC advertising and in reducing
consumers' exposure to false and misleading advertising.
Background:
FDA regulates the content of all prescription drug advertising, whether
directed to consumers or medical professionals. Advertising that is
targeted to consumers includes both DTC and "consumer-directed"
materials. DTC advertising includes, for example, broadcast
advertisements (such as those on television and radio), print
advertisements (such as those in magazines and newspapers), and
Internet advertisements (such as consumer advertising on drug
companies' Web sites). In contrast, consumer-directed advertisements
are designed to be given by medical professionals to consumers and
include, for example, patient brochures provided in doctors' offices.
Advertising materials must contain a "true statement" of information
including a brief summary of side effects, contraindications, and the
effectiveness of the drug.[Footnote 6] To meet this requirement,
advertising materials must not be false or misleading, must present a
fair balance of the risks and benefits of the drug, and must present
any facts that are material to the use of the drug or claims made in
the advertising. With the exception of broadcast advertisements,
materials must present all of the risks described in the drug's
approved labeling. Broadcast materials may present only the major side
effects and contraindications, provided the materials make "adequate
provision" to give consumers access to the information in the drug's
approved or permitted package labeling.[Footnote 7]
Within FDA, DDMAC is responsible for implementing the laws and
regulations that apply to prescription drug advertising. In March 2002,
DDMAC created a DTC Review Group, which is responsible for oversight of
advertising materials that are directed to consumers. As of May 2008,
the group had a total of two group leaders, seven reviewers, and two
social scientists. This group's responsibilities include reviewing
final DTC materials and reviewing and providing advisory comments on
draft DTC materials. The group also monitors television, magazines, and
consumer advertising on drug companies' Web sites to identify
advertising materials that were not submitted to FDA at the time they
were first disseminated and reviews advertising materials cited in
complaints submitted by competitors, consumers, and others.
Once submitted to FDA, final and draft DTC advertising materials are
distributed to a DTC reviewer. For final materials, if the reviewer
identifies a concern, the agency determines whether it represents a
violation and merits a regulatory letter. For draft materials submitted
by drug companies, FDA may provide the drug company with advisory
comments to consider before the materials are disseminated to consumers
if, for example, the reviewers identify claims in materials that could
violate applicable laws and regulations.
If FDA identifies violations in disseminated DTC materials, the agency
may issue two types of regulatory letters--either a "warning letter" or
an "untitled letter." Warning letters are typically issued for
violations that may lead FDA to pursue additional enforcement actions
if not corrected; untitled letters are issued for violations that do
not meet this threshold. Both types of letters cite the type of
violation identified in the company's advertising material, request
that the company submit a written response to FDA within 14 days, and
request that the company take specific actions. Untitled letters
request that companies stop disseminating the cited advertising
materials and other advertising materials with the same or similar
claims. Warning letters further request that the company issue
advertising materials to correct the misleading impressions left by the
violative advertising materials.[Footnote 8] The draft regulatory
letters are subsequently reviewed by officials in DDMAC, FDA's Office
of Medical Policy (which oversees DDMAC), and OCC. FDA has stated that
it instituted OCC review for the purpose of promoting voluntary
compliance by ensuring that drug companies that receive a regulatory
letter understand that the letter has undergone legal review and the
agency is prepared to go to court if necessary.[Footnote 9]
FDA Reviewed a Small Portion of DTC Materials and Could Not Ensure It
Was Reviewing the Highest-Priority Materials:
As of 2006, FDA reviewed a small portion of the increasingly large
number of DTC materials it received. FDA attempted to target available
resources by focusing its reviews on the DTC advertising materials that
had the greatest potential to negatively affect public health, but the
agency did not document criteria for prioritizing the materials it
received for review. Agency reviewers considered several informal
criteria when prioritizing the materials, but these were not
systematically applied and the agency did not document if a particular
DTC material was reviewed. As a result, the agency could not ensure
that it was identifying or reviewing the materials that were the
highest priority.
FDA officials told us at the time of our 2006 report that the agency
received substantially more final and draft materials than the DTC
Review Group could review. In 2005, FDA received 4,600 final DTC
materials (excluding Internet materials) and 6,168 final Internet
materials.[Footnote 10] FDA also received 4,690 final consumer-directed
materials--such as brochures given to consumers by medical
professionals. FDA received a steadily increasing number of final
materials from 1999 through 2005. We found that, in 2006 and 2007, the
total number of final DTC, Internet, and consumer-directed materials
FDA received continued to increase.[Footnote 11] (See fig. 1.)
Figure 1: Number of Final DTC, Internet, and Consumer-Directed
Materials Submitted to FDA, 1999 through 2007:
This figure is a vertical bar graph showing number of final DTC,
internet, and consumer-directed materials submitted to FDA, 1999
through 2007. The X axis represents the year, and the Y axis represents
the numbers in thousands.
Year: 1999;
Numbers in thousands: 6.
Year: 2000;
Numbers in thousands: 7.
Year: 2001;
Numbers in thousands: 9.
Year: 2002;
Numbers in thousands: 9.
Year: 2003;
Numbers in thousands: 10.
Year: 2004;
Numbers in thousands: 14.
Year: 2005;
Numbers in thousands: 15.
Year: 2006;
Numbers in thousands: 18.
Year: 2007;
Numbers in thousands: 21.
(Numbers rounded to make whole numbers.)
[See PDF for image]
Source: GAO analysis of FDA data.
[End of figure]
FDA officials estimated that reviewers spent the majority of their time
reviewing and commenting on draft materials. However, we were unable to
determine the number of final or draft materials FDA reviewed, because
FDA did not track this information. In the case of final and draft
broadcast materials, FDA officials told us that the DTC group reviewed
all of the materials it received; in 2005, it received 337 final and
146 draft broadcast materials. However, FDA did not document whether
these or other materials it received had been reviewed. As a result,
FDA could not determine how many materials it reviewed in a given year.
We recommended in our 2006 report that the agency track which DTC
materials had been reviewed. FDA officials indicated to us in May 2008
that the agency still did not track this information.
At the time of our 2006 report, FDA officials identified informal
criteria that the agency used to prioritize its reviews. FDA officials
told us that, to target available resources, the agency prioritized the
review of the DTC advertising materials that had the greatest potential
to negatively affect public health. We recommended that FDA document
its criteria for prioritizing its reviews of DTC advertising materials.
FDA informed us in May 2008 that it now has documented criteria to
prioritize reviews. For example, its first priority is to review
materials with "egregious" violations, such as those identified through
complaints. In addition, FDA places a high priority on reviewing
television advertising materials. FDA officials also told us that the
agency places a high priority on reviewing draft materials because they
provide the agency with an opportunity to identify problems and ask
drug companies to correct them before the materials are disseminated to
consumers.
We reported in 2006 that FDA did not systematically apply its criteria
for prioritizing reviews to all of the materials that it received.
Specifically, we found in 2006 that, at the time FDA received the
materials, it recorded information about the drug being advertised and
the type of material being submitted but did not screen the DTC
materials to identify those that met its various informal criteria. FDA
officials told us that the agency did identify all final and draft
broadcast materials that it received, but it did not have a system for
identifying any other high-priority materials. Absent such a system for
all materials, FDA relied on each of the reviewers--in consultation
with other DDMAC officials--to be aware of the materials that had been
submitted and to accurately apply the criteria to determine the
specific materials to review. This created the potential for reviewers
to miss materials that the agency would consider to be a high priority
for review. Furthermore, because FDA did not track information on its
reviews, the agency could not determine whether a particular material
had been reviewed. As a result, the agency could not ensure that it
identified and reviewed the highest-priority materials. We recommended
that the agency systematically screen the DTC materials it received
against its criteria to identify those that are the highest priority
for review. As of May 2008, FDA still did not have such a process.
After the 2002 Policy Change, FDA's Process for Issuing Regulatory
Letters Took Longer and the Number of Letters Issued Declined:
In 2006 we reported that, after the 2002 policy change requiring legal
review by OCC of all draft regulatory letters, the agency's process for
drafting and issuing letters citing violative DTC materials had
stretched to several months and FDA had issued fewer regulatory letters
per year. As a result of the policy change, draft regulatory letters
received additional levels of review and the DTC reviewers who drafted
the letters did substantially more work to prepare for and respond to
comments resulting from review by OCC. FDA officials told us that the
agency issued letters for only the violative DTC materials that it
considered the most serious and most likely to negatively affect
consumers' health.
Once FDA identified a violation in a DTC advertising material and
determined that it merited a regulatory letter, FDA took several months
to draft and issue a letter. For letters issued from 2002 through 2005,
once DDMAC began drafting the letter for violative DTC materials it
took an average of about 4 months to issue the letter. The length of
this process varied substantially across these regulatory letters--one
letter took around 3 weeks from drafting to issuance, while another
took almost 19 months. In comparison, for regulatory letters issued
from 1997 through 2001, it took an average of 2 weeks from drafting to
issuance. We recommended in 2002 that the agency reduce the amount of
time to draft and issue letters and the agency agreed. We found in
2006, however, that the review time had increased and we again urged
the agency to issue the letters more quickly. In 2006 and 2007, it took
an average of more than 5 months from drafting to issuance. One letter
took less than 2 months to issue while another took about 11 months.
(See fig. 2 for the average months from 1997 through 2007.)
Figure 2: Average Months to Issue Regulatory Letters Citing Violative
DTC Materials, 1997 through 2007:
This figure is a versicle bar graph showing average months to issue
regulatory letters citing violative DTC materials, 1997 through 2007.
The X axis represents the year, and the Y axis represents the months to
issue regulatory letters (initial draft to issuance).
Year: 1997;
Months to issue regulatory letters: 0.3.
Year: 1998;
Months to issue regulatory letters: 0.3.
Year: 1999;
Months to issue regulatory letters: 0.7.
Year: 2000;
Months to issue regulatory letters: 0.7.
Year: 2001;
Months to issue regulatory letters: 0.7.
Year: 2002;
Months to issue regulatory letters: 2.
Year: 2003;
Months to issue regulatory letters: 4.6.
2004;
Months to issue regulatory letters: 5.1.
Year: 2005;
Months to issue regulatory letters: 3.5.
Year: 2006;
Months to issue regulatory letters: 4.63.
Year: 2008;
Months to issue regulatory letters: 6.17.
[See PDF for image]
Note: For each letter, we determined the number of months from the date
on which a reviewer first began drafting a regulatory letter to the
date the letter was issued. FDA does not track the date a violation was
identified or the date it was determined that the violation merited a
regulatory letter.
[End of figure]
The primary factor that contributed to the increase in the length of
FDA's process for issuing regulatory letters was the additional work
that resulted from the 2002 policy change. All DDMAC regulatory letters
were reviewed by both OCC staff and OCC's Chief Counsel. In addition to
the time required of OCC, DDMAC officials told us that the policy
change created the need for substantially more work on their part to
prepare the necessary documentation for legal review. After meeting
with OCC and revising the draft regulatory letter to reflect the
comments from OCC, DDMAC would formally submit a draft letter to OCC
for legal review and approval. OCC often required additional revisions
before it would concur that a letter was legally supportable and could
be issued. While OCC officials told us that the office had given
regulatory letters that cited violative DTC materials higher priority
than other types of regulatory letters, their review of DDMAC's draft
regulatory letters was a small portion of their other responsibilities
and had to be balanced with other requests, such as the examination of
legal issues surrounding the approval of a new drug. Recently, FDA
informed us that it now allows some steps to be eliminated--if deemed
unnecessary for a particular letter--in an attempt to make the legal
review process more efficient.
The number of regulatory letters FDA issued per year for violative DTC
materials decreased after the 2002 policy change lengthened the
agency's process for issuing letters. From 2002 to 2005, the agency
issued between 8 and 11 regulatory letters per year that cited DTC
materials. Prior to the policy change, from 1997 through 2001, FDA
issued between 15 and 25 letters citing DTC materials per year. An FDA
official told us that both the lengthened review time resulting from
the 2002 policy change and staff turnover within the DTC Review Group
contributed to the decline in the number of issued regulatory letters.
More recently, we found that the number of letters issued that cite DTC
materials has continued to decline--FDA issued 4 letters in 2006 and 2
letters in 2007. (See fig. 3 for the number of letters issued from 1997
through 2007.)
Figure 3: Number of Regulatory Letters FDA Issued That Cited DTC
Advertising Materials, 1997 through 2007:
This figure is a vertical combination bar graph showing number of
regulatory letters FDA issued that cited DTC advertising materials,
1997 to 2007. The X axis repredents the year, and the Y axis represents
the numbers of letters. One bar represents the warning letters, and the
second bar represents untitled letters.
Year: 1997;
Warning letters: 17;
Untitled letters: 2.
1998;
Warning letters: 25;
Untitled letters: 0.
1999;
Warning letters: 16;
Untitled letters: 2.
2000;
Warning letters: 20;
Untitled letters: 1.
2001;
Warning letters: 14;
Untitled letters: 1.
2002;
Warning letters: 9;
Untitled letters: 0.
2003;
Warning letters: 7;
Untitled letters: 2.
2004;
Warning letters: 8;
Untitled letters: 3.
2005;
Warning letters: 5;
Untitled letters: 3.
2006;
Warning letters: 1;
Untitled letters: 3.
2007;
Warning letters: 1;
Untitled letters: 1.
[See PDF for image]
[End of figure]
Although the total number of regulatory letters FDA issued for
violative DTC materials has decreased, the agency has issued in recent
years proportionately more warning letters--which cite violations FDA
considers to be more serious. Historically, almost all of the
regulatory letters that FDA issued for DTC materials were untitled
letters for less serious violations. From 1997 through 2001, FDA issued
98 regulatory letters citing DTC advertising materials, 6 of which were
warning letters. From 2002 through 2005, 8 of the 37 regulatory letters
were warning letters. Of the 6 letters FDA issued for DTC materials in
2006 and 2007, 4 were warning letters.
FDA regulatory letters may cite more than one DTC material or type of
violation for a given drug. Of the 19 regulatory letters FDA issued
from 2004 through 2005, 7 cited more than 1 DTC material, for a total
of 31 different materials. These 31 materials appeared in a range of
media, including television, radio, print, direct mail, and the
Internet. Further, FDA identified multiple violations in 21 of the 31
DTC materials cited in the letters. The most commonly cited violations
related to a failure of the material to accurately communicate
information about the safety of the drug. The letters also often cited
materials for overstating the effectiveness of the drug or using
misleading comparative claims. Of the 6 regulatory letters FDA issued
in 2006 or 2007 that cited DTC materials, 2 cited more than 1 DTC
material and all identified multiple violations in each of the cited
materials.
For our 2006 report, FDA officials told us, that the agency issued
regulatory letters for DTC materials that it believed were the most
likely to negatively affect consumers and that it did not act on all of
the concerns that its reviewers identified. For example, they said the
agency may be more likely to issue a letter when a false or misleading
material was broadly disseminated. When reviewers had concerns about
DTC materials, they discussed them with others in DDMAC and may have
met with OCC and medical officers in FDA's Office of New Drugs to
determine whether a regulatory letter was warranted. However, because
FDA did not document decisions made at the various stages of its review
process about whether to pursue a violation, officials were unable to
provide us with an estimate of the number of materials about which
concerns were raised but the agency did not issue a letter.
Effectiveness of FDA Regulatory Letters at Halting Dissemination of
Violative DTC Materials Was Limited:
At the time of our 2006 report, we found that FDA regulatory letters
were limited in their effectiveness at halting the dissemination of
false and misleading DTC advertising materials. We found that, from
2004 through 2005, FDA issued regulatory letters an average of about 8
months after the violative DTC materials they cited were first
disseminated, by which time more than half of the materials had already
been discontinued. Although drug companies complied with FDA's requests
to create materials to correct the misimpressions left by the cited
materials, these corrections were not disseminated until 5 months or
more after FDA issued the regulatory letter. Furthermore, FDA's
regulatory letters did not always prevent drug companies from later
disseminating similar violative materials for the same drugs.
Because of the length of time it took FDA to issue these letters,
violative advertisements were often disseminated for several months
before the letters were issued. From 2004 through 2005, FDA issued
regulatory letters citing DTC materials an average of about 8 months
after the violative materials were first disseminated. FDA issued one
letter less than 1 month after the material was first disseminated,
while another letter took over 3 years. The cited materials were
usually disseminated for 3 or more months, and of the 31 violative DTC
materials cited in these letters, 16 were no longer being disseminated
by the time the letter was issued. On average, these letters were
issued more than 4 months after the drug company stopped disseminating
these materials and therefore had no effect on their dissemination. For
the 14 DTC materials that were still in use when FDA issued the letter,
the drug companies complied with FDA's request to stop disseminating
the violative materials. However, by the time the letters were issued,
these 14 materials had been disseminated for an average of about 7
months.[Footnote 12]
As requested by FDA in the regulatory letters, drug companies often
identified and stopped disseminating other materials with claims
similar to those in the violative materials. For 18 of the 19
regulatory letters issued from 2004 through 2005, the drug companies
indicated to FDA that they had either identified additional similar
materials or that they were reviewing all materials to ensure
compliance. In addition to halting materials directed to consumers,
companies responding to 11 letters also stopped disseminating materials
with similar claims that were targeted directly to medical
professionals.
Drug companies disseminated the corrective advertising materials
requested in FDA warning letters, but took 5 months or more to do so.
In each of the six warning letters FDA issued in 2004 and 2005 that
cited DTC materials, the agency asked the drug company to disseminate
truthful, nonmisleading, and complete corrective messages about the
issues discussed in the regulatory letter to the audiences that
received the violative promotional materials. In each case, the drug
company complied with this request by disseminating corrective
advertising materials. For the six warning letters FDA issued in 2004
and 2005 that cited DTC materials, the corrective advertising materials
were initially disseminated more than 5 to almost 12 months after FDA
issued the letter. For example, for one allergy medication, the
violative advertisements ran from April through October 2004, FDA
issued the regulatory letter in April 2005, and the corrective
advertisement was not issued until January 2006.
FDA regulatory letters did not always prevent the same drug companies
from later disseminating violative DTC materials for the same drug,
sometimes using the same or similar claims. From 1997 through 2005, FDA
issued regulatory letters for violative DTC materials used to promote
89 different drugs. Of these 89 drugs, 25 had DTC materials that FDA
cited in more than one regulatory letter, and one drug had DTC
materials cited in eight regulatory letters.[Footnote 13] For 15 of the
25 drugs, FDA cited similar broad categories of violations in multiple
regulatory letters. For example, FDA issued regulatory letters citing
DTC materials for a particular drug in 2000 and again in 2005 for
"overstating the effectiveness of the drug." For 4 of the 15 drugs, FDA
cited the same specific violative claim for the same drug in more than
one regulatory letter. For example, in 1999 FDA cited a DTC direct mail
piece for failing to convey important information about the limitations
of the studies used to approve the promoted drug. In 2001, FDA cited a
DTC broadcast advertisement for the same drug for failing to include
that same information.
Concluding Observations:
Given substantial growth in the number of DTC advertising materials
submitted to FDA in recent years, FDA's role in limiting the
dissemination of false or misleading advertising to the American public
has become increasingly important. Fulfilling this responsibility
requires that the agency, among other things, review those DTC
advertising materials that are highest priority and take timely action
to limit the dissemination of those that are false or misleading. We
found in 2006 that FDA did not have a complete and systematic process
for tracking and prioritizing all materials that it received for
review. FDA's development of documented criteria to prioritize reviews
is a step in the right direction. However, as we recommended in 2006,
we believe that FDA should take the next step of systematically
applying those criteria to the DTC materials it receives to determine
which are highest priority for review. While the agency said that it
would require vastly increased staff to systematically screen
materials, we found in 2006 that FDA already has most of the
information it would need to do so. Finally, despite FDA agreeing in
2002 that it is important to issue regulatory letters more quickly, the
amount of time it takes to draft and issue letters has continued to
lengthen. We believe that delays in issuing regulatory letters limit
FDA's effectiveness in overseeing DTC advertising and in reducing
consumers' exposure to false and misleading advertising.
Mr. Chairman, this completes my prepared statement. I would be happy to
respond to any questions you or the other members of the subcommittee
may have at this time.
Contacts and Acknowledgments:
For further information about this statement, please contact Marcia
Crosse, 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 statement. Martin T. Gahart, Assistant Director;
Chad Davenport; William Hadley; Cathy Hamann; Julian Klazkin; and Eden
Savino made key contributions to this statement.
[End of section]
Footnotes:
[1] 21 C.F.R. § 314.81(b)(3)(i)(2007).
[2] 21 C.F.R. § 202.1(j)(4)(2007). The FDA Amendments Act of 2007
provided FDA with new authorities related to the oversight of DTC
advertising. The Act, among other things, authorizes FDA to require the
submission of any draft television drug advertisement for review up to
45 days before it is scheduled to be disseminated. See Pub. L. No. 110-
85, § 901(d)(2), 121 Stat. 823, 939 (2007), codified at 21 U.S.C. §
353b.
[3] The Pharmaceutical Research and Manufacturers of America (PhRMA)
issued guidance effective January 2006 that states that "[drug]
companies should submit all new DTC television drug advertisements to
the FDA before releasing these advertisements for broadcast." PhRMA
Guiding Principles: Direct to Consumer Advertisements about
Prescription Medicines (Washington, D.C.: PhRMA, November 2005),
[hyperlink, http://www.phrma.org/files/DTCGuidingprinciples.pdf]
(accessed Apr. 29, 2008).
[4] GAO, Prescription Drugs: FDA Oversight of Direct-to-Consumer
Advertising Has Limitations, GAO-03-177 (Washington, D.C.: Oct. 28,
2002).
[5] GAO, Prescription Drugs: Improvements Needed in FDA's Oversight of
Direct-to-Consumer Advertising, GAO-07-54 (Washington, D.C.: Nov. 16,
2006).
[6] 21 C.F.R. § 202.1(e)(1),(2)(2007). Those advertising materials that
call attention to the name of the drug but do not include indication or
dosage recommendations for use of the drug are exempt from these brief
summary requirements.
[7] FDA published draft guidance for DTC broadcast advertisements in
1997, and final guidance in 1999, that described an approach drug
companies could use to meet the regulatory requirement for making
adequate provision of key information. The outlined approach provides
that drug companies disseminate complete information included in a
drug's approved package labeling through alternative sources, such as a
toll-free number and a drug company Web site. See FDA, Guidance for
Industry: Consumer-Directed Broadcast Advertisements (Rockville, Md.:
Aug. 1999).
[8] While FDA does not have explicit authority to require companies to
act upon these letters, if the companies continue to violate applicable
laws or regulations, the agency has other administrative and judicial
enforcement avenues that could encourage compliance or result in the
product being taken off the market. For example, FDA, through the
Department of Justice, may seek additional remedies in the courts
resulting in the seizure of drugs deemed to be misbranded because their
advertising is false or misleading. With the enactment of the FDA
Amendments Act of 2007, FDA was also authorized to assess civil
monetary penalties. Pub. L. No. 110-85, § 901(d)(4), 121 Stat. 823, 940-
942 (2007), codified at 21 U.S.C. § 333(g).
[9] See GAO-03-177, 32.
[10] FDA's count of submitted materials did not distinguish between
Internet materials targeted to consumers and those targeted to medical
professionals. However, FDA officials told us that most Internet
materials, such as drug companies' Web sites, include both a consumer
and a professional component.
[11] We could not determine whether there had been a similar increase
in the number of draft DTC materials FDA received because the agency
did not track this information.
[12] For one violative advertising material, we were unable to
determine from FDA's files when the violative advertising material
ended.
[13] In 2006 and 2007, FDA issued 6 letters for drugs that had not
previously been cited in regulatory letters. As of April 2008, the
agency had issued one regulatory letter for a drug that had been cited
in 2 previous regulatory letters.
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