Prescription Drugs
Enhanced Efforts and Better Agency Coordination Needed to Address Illegal Importation
Gao ID: GAO-06-175T December 13, 2005
This testimony summarizes a GAO report on federal efforts to address the importation of prohibited prescription drugs through international mail and carrier facilities for personal use. U.S. Customs and Border Protection (CBP), in the Department of Homeland Security (DHS), and the Food and Drug Administration (FDA), in the Department of Health and Human Services (HHS), work with other federal agencies at international mail and express carrier facilities to inspect for and interdict these drugs. This testimony addresses (1) available data about the volume and safety of these drugs, (2) the procedures and practices used to inspect and interdict them, (3) factors affecting federal efforts to enforce the laws governing these drugs, and (4) federal agencies' efforts to coordinate enforcement of the prohibitions on personal importation of these drugs.
The information currently available on the safety of illegally imported prescription drugs is very limited, and neither CBP nor FDA systematically collects data on the volume of these imports. Nevertheless, on the basis of their own observations and limited information they collected at some mail and carrier facilities, both CBP and FDA officials said that the volume of prescription drugs imported into the United States is substantial and increasing. FDA officials said that they cannot assure the public of the safety of drugs purchased from foreign sources outside the U.S. regulatory system. FDA has issued new procedures to standardize practices for selecting packages for inspection and making admissibility determinations. While these procedures may encourage uniform practices across mail facilities, packages containing prescription drugs continue to be released to the addressees. CBP has also implemented new procedures to interdict and destroy certain imported controlled substances, such as Valium. CBP officials said the new process is designed to improve their ability to quickly handle packages containing these drugs, but they did not know if the policy had affected overall volume because packages may not always be detected. GAO identified three factors that have complicated federal enforcement of laws prohibiting the personal importation of prescription drugs. First, the volume of imports has strained limited federal resources at mail facilities. Second, Internet pharmacies can operate outside the U.S. regulatory system and evade federal law enforcement actions. Third, current law requires FDA to give addressees of packages containing unapproved imported drugs notice and the opportunity to provide evidence of admissibility regarding their imported items. FDA and HHS have testified before Congress that this process placed a burden on limited resources. In May 2001, FDA proposed to the HHS Secretary that this legal requirement be eliminated, but according to FDA and HHS officials, as of July 2005, the Secretary had not respondedwith a proposal. FDA officials stated that any legislative change might require consideration of such issues as whether to forgo an individual's opportunity to provide evidence of the admissibility of the drug ordered. Prior federal task forces and working groups had taken steps to deal with Internet sales of prescription drugs since 1999, but these efforts did not position federal agencies to successfully address the influx of these drugs imported from foreign sources. Recently, CBP has organized a task force to coordinate federal agencies' activities to enforce the laws prohibiting the personal importation of prescription drugs. The task force's efforts appear to be steps in the right direction, but they could be enhanced by establishing a strategic framework to define the scope of the problem at mail and carrier facilities, determine resource needs, establish performance measures, and evaluate progress. Absent this framework, it will be difficult to oversee task force efforts; hold agencies accountable; and ensure ongoing, focused attention to the enforcement of the relevant laws.
GAO-06-175T, Prescription Drugs: Enhanced Efforts and Better Agency Coordination Needed to Address Illegal Importation
This is the accessible text file for GAO report number GAO-06-175T
entitled 'Prescription Drugs: Enhanced Efforts and Better Agency
Coordination Needed to Address Illegal Importation' which was released
on December 13, 2005.
This text file was formatted by the U.S. Government Accountability
Office (GAO) to be accessible to users with visual impairments, as part
of a longer term project to improve GAO products' accessibility. Every
attempt has been made to maintain the structural and data integrity of
the original printed product. Accessibility features, such as text
descriptions of tables, consecutively numbered footnotes placed at the
end of the file, and the text of agency comment letters, are provided
but may not exactly duplicate the presentation or format of the printed
version. The portable document format (PDF) file is an exact electronic
replica of the printed version. We welcome your feedback. Please E-mail
your comments regarding the contents or accessibility features of this
document to Webmaster@gao.gov.
This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed
in its entirety without further permission from GAO. Because this work
may contain copyrighted images or other material, permission from the
copyright holder may be necessary if you wish to reproduce this
material separately.
Testimony:
Before the Subcommittee on Oversight and Investigations, Committee on
Energy and Commerce, U.S. House of Representatives:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 1:00 p.m. EST:
Tuesday, December 13, 2005:
Prescription Drugs:
Enhanced Efforts and Better Agency Coordination Needed to Address
Illegal Importation:
Statement of Richard M. Stana, Director:
Homeland Security and Justice Issues:
GAO-06-175T:
GAO Highlights:
Highlights of GAO-06 175T, a testimony before the Subcommittee on
Oversight and Investigations, Committee on Energy and Commerce, U.S.
House of Representatives:
Why GAO Did This Study:
This testimony summarizes a GAO report on federal efforts to address
the importation of prohibited prescription drugs through international
mail and carrier facilities for personal use. U.S. Customs and Border
Protection (CBP), in the Department of Homeland Security (DHS), and the
Food and Drug Administration (FDA), in the Department of Health and
Human Services (HHS), work with other federal agencies at international
mail and express carrier facilities to inspect for and interdict these
drugs. This testimony addresses (1) available data about the volume and
safety of these drugs, (2) the procedures and practices used to inspect
and interdict them, (3) factors affecting federal efforts to enforce
the laws governing these drugs, and (4) federal agencies‘ efforts to
coordinate enforcement of the prohibitions on personal importation of
these drugs.
What GAO Found:
The information currently available on the safety of illegally imported
prescription drugs is very limited, and neither CBP nor FDA
systematically collects data on the volume of these imports.
Nevertheless, on the basis of their own observations and limited
information they collected at some mail and carrier facilities, both
CBP and FDA officials said that the volume of prescription drugs
imported into the United States is substantial and increasing. FDA
officials said that they cannot assure the public of the safety of
drugs purchased from foreign sources outside the U.S. regulatory
system.
FDA has issued new procedures to standardize practices for selecting
packages for inspection and making admissibility determinations. While
these procedures may encourage uniform practices across mail
facilities, packages containing prescription drugs continue to be
released to the addressees. CBP has also implemented new procedures to
interdict and destroy certain imported controlled substances, such as
Valium. CBP officials said the new process is designed to improve their
ability to quickly handle packages containing these drugs, but they did
not know if the policy had affected overall volume because packages may
not always be detected.
GAO identified three factors that have complicated federal enforcement
of laws prohibiting the personal importation of prescription drugs.
First, the volume of imports has strained limited federal resources at
mail facilities. Second, Internet pharmacies can operate outside the
U.S. regulatory system and evade federal law enforcement actions.
Third, current law requires FDA to give addressees of packages
containing unapproved imported drugs notice and the opportunity to
provide evidence of admissibility regarding their imported items. FDA
and HHS have testified before Congress that this process placed a
burden on limited resources. In May 2001, FDA proposed to the HHS
Secretary that this legal requirement be eliminated, but according to
FDA and HHS officials, as of July 2005, the Secretary had not responded
with a proposal. FDA officials stated that any legislative change might
require consideration of such issues as whether to forgo an
individual‘s opportunity to provide evidence of the admissibility of
the drug ordered.
Prior federal task forces and working groups had taken steps to deal
with Internet sales of prescription drugs since 1999, but these efforts
did not position federal agencies to successfully address the influx of
these drugs imported from foreign sources. Recently, CBP has organized
a task force to coordinate federal agencies‘ activities to enforce the
laws prohibiting the personal importation of prescription drugs. The
task force‘s efforts appear to be steps in the right direction, but
they could be enhanced by establishing a strategic framework to define
the scope of the problem at mail and carrier facilities, determine
resource needs, establish performance measures, and evaluate progress.
Absent this framework, it will be difficult to oversee task force
efforts; hold agencies accountable; and ensure ongoing, focused
attention to the enforcement of the relevant laws.
What GAO Recommends:
GAO recommends that (1) CBP and other task force agencies develop a
strategic framework to enhance their enforcement efforts and (2) HHS
assess the effect of modifying the requirement that FDA notify
addressees about unapproved drug imports. DHS and most task force
agencies generally supported the idea of a strategic framework. HHS
agreed to assess modifying the notification requirement, and the U.S.
Postal Service said that any proposal should consider international
postal obligations.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I appreciate the opportunity to provide a summary of our recent report
on federal agencies' efforts to address the importation of prohibited
prescription drugs through international mail and carrier
facilities.[Footnote 1]
The advent of online Internet pharmacy services in early 1999, enabled
American consumers to order over the Internet a range of prescription
drugs from controlled substances,[Footnote 2] such as Valium, to
noncontrolled prescription drugs intended to improve an individual's
quality of life by addressing non-life-threatening conditions such as
baldness, impotence, and obesity. The broad reach and access of the
Internet allow the easy creation of online pharmacies that anonymously
traverse state and national borders to prescribe, sell, and dispense
prescription drugs without complying with traditional state or federal
regulatory safeguards.
Under current law, the importation of prescription drugs, both
controlled and noncontrolled, for personal use is illegal, with few
exceptions. In recent years, Congress and others have debated whether
Americans should be allowed to purchase drugs from pharmacies located
in foreign countries. However, currently, consumers could be violating
federal law, unknowingly or intentionally, by having drugs shipped, in
effect, imported, into the United States through the international mail
and private carriers. Two acts specifically regulate the importation of
prescription drugs into the United States. That is, all prescription
drugs offered for import must meet the requirements of the Federal
Food, Drug, and Cosmetic Act, and those that are controlled substances
also must meet the requirements of the Controlled Substances Import and
Export Act. Prescription drugs imported for personal use generally do
not meet these requirements.
Several federal agencies have responsibility for regulating the
importation of prescription drugs through the international mail and
private carriers. They include the Department of Homeland Security's
(DHS) U.S. Customs and Border Protection (CBP), which can inspect
international mail and packages for potentially illegal drugs entering
the United States through the U.S. Postal Service's (USPS)
international mail facilities or private carriers; the Department of
Health and Human Services' (HHS) Food and Drug Administration (FDA),
which is responsible for ensuring the safety, effectiveness, and
quality of domestic and imported drugs; the Department of Justice's
Drug Enforcement Administration (DEA), which regulates controlled
substances; and the Department of Homeland Security's U.S. Immigration
and Customs Enforcement (ICE), which has law enforcement
responsibilities that include investigations of prescription drugs
coming into the United States through the mail and express carriers.
Also, the Office of National Drug Control Policy (ONDCP) formulates the
nation's drug control strategy and addresses policy issues concerning
the illegal distribution of controlled substances, as its authority
does not extend over noncontrolled substances.
This statement presents a summary of our latest work on federal efforts
to enforce prohibitions on personal importation of prescription drugs
through the international mail and carrier facilities, which was
requested by the Chairman of the Senate Permanent Subcommittee on
Investigations, Committee on Homeland Security and Governmental Affairs
and the Ranking Minority Member of the House Energy and Commerce
Committee. My testimony today, requested by the Chairman of this
Subcommittee, provides a summary of our report and will focus on the
following issues:
* what available data show about the volume and safety of prescription
drugs imported into the United States for personal use through the
international mail and private carriers,
* what procedures and practices are used at selected facilities to
inspect and interdict prescription drugs unapproved for import,
* what factors affect federal agency efforts to enforce the prohibition
on prescription drug importation for personal use through international
mail and carrier facilities, and:
* what efforts federal agencies have undertaken to coordinate the
enforcement of the prohibitions on personal importation of prescription
drugs.
Summary:
Our report on illegal prescription drug importation notes that the
information currently available on the safety of illegally imported
prescription drugs is very limited, and neither CBP nor FDA
systematically collects data on the volume of these imports.
Nevertheless, on the basis of their own observations and limited
information they have collected at some mail and carrier facilities,
both CBP and FDA officials said the volume of prescription drugs
imported into the United States is substantial. For example, a December
2004 HHS report states that approximately 10 million packages
containing prescription drugs enter the United States annually from all
over the world. However, this estimate has limitations, being partially
based on extrapolations from limited FDA observations at international
mail branch facilities. Without reliable estimates of the volume of
importation of prescription drugs, federal agencies cannot determine
the full scope of the importation issue, which is of particular concern
because of access to potentially unsafe or risky drugs, including
highly addictive controlled substances. With regard to safety, the FDA
officials told us that they cannot assure the public of the safety and
quality of drugs purchased from foreign sources that are largely
outside the U.S. regulatory system. Consistent with these concerns, in
June 2004, we reported that a sample of drugs purchased from some
foreign-based Internet pharmacies posed safety risks for
consumers.[Footnote 3]
Regarding the practices used at the mail and carrier facilities we
visited to inspect packages and interdict prohibited prescription
drugs, our report states that both FDA's and CBP's procedures are
evolving. FDA issued procedures in August 2004 to standardize the
selection of packages by CBP and the forwarding of them to FDA for
inspection. These procedures include guidelines for inspecting the
packages and making admissibility determinations. However, under the
current procedures, similar to previous practices, many packages that
contain prescription drugs prohibited for import are released to
addressees. For example, packages that contain prescription drugs
prohibited for import that have not been processed by FDA inspectors at
the end of each workday are returned by FDA for delivery by USPS to the
recipient. CBP has also implemented a new policy to expedite its
handling of schedule III through V controlled substances imported as
prescription drugs. Until recently, CBP was required to seize and begin
forfeiture proceedings on packages of such controlled substances it
detected--a process CBP considered to be time-consuming given the
volume of controlled substances entering some facilities. In September
2004, CBP determined it could treat schedule III through V controlled
substances as abandoned property, thereby (1) reducing the amount of
information recorded about the drugs and (2) enabling CBP to destroy
the drugs 30 days after notifying the addressee that the drugs would be
treated as abandoned property if not claimed.
In our report, we also identify three factors beyond inspection and
interdiction issues that have complicated federal efforts to enforce
laws prohibiting the importation of prescription drugs for personal
use. First, the volume of importation has strained federal resources at
the mail and carrier facilities. According to officials we contacted,
agencies have multiple priorities, which can constrain the resources
they are able to allocate to the inspection and interdiction of
prescription drugs and controlled substances imported through mail and
carrier facilities. Second, the attributes of Internet pharmacies have
posed challenges to law enforcement efforts for multiple reasons. For
example, Internet sites can be installed, moved, or removed in a short
period of time, making it difficult for law enforcement agencies to
identify, track, monitor, or shut down those sites that operate
illegally. Additionally, legal and practical considerations can limit
the nature and extent to which commercial firms (e.g., Internet
providers and credit card organizations) can assist in federal law
enforcement actions. Third, the notification process in current law
requiring FDA to hold packages containing items that appear unapproved
for import and give the addressee the opportunity to provide evidence
of admissibility is, according to FDA officials, time-consuming æ
taking up to 30 days per import æ and can hinder their ability to
quickly process packages containing potentially unapproved prescription
drugs. FDA and the Secretary of Health and Human Services have
expressed concerns about this process during testimony before Congress.
However, FDA officials told us that any legislative change might
necessitate consideration of some complicated issues, including whether
the government would want to forgo an individual's opportunity to
provide evidence of admissibility for the drug(s) that had been
ordered, or what imported prescription drugs and other imported
products within FDA's jurisdiction should be covered by the new law. In
addition, USPS indicated that any discussion of options to expedite the
processing and disposition of prescription drugs should consider
international postal obligations established by the Universal Postal
Union (UPU).[Footnote 4]
We also report that CBP has organized a task force to coordinate the
activities of federal agencies responsible for enforcing laws
prohibiting the personal importation of prescription drugs. Among other
things, the task force has performed joint operations to gather data on
the type and source of unapproved drugs entering international mail
facilities and developed public service campaigns to inform the public
about the risks of buying prescription drugs from Internet providers in
foreign countries. Although the task force appears to be a step in the
right direction, efforts to address many of the challenges facing these
agencies could be further enhanced if the task force established a
strategic framework to promote accountability and guide resource and
policy decisions. Our past work has shown that a strategic framework is
particularly useful in addressing problems, such as prescription drug
importation, that are national in scope and involve multiple agencies
with varying jurisdictions. Without such a strategic framework, it will
be difficult for agency officials and congressional decision makers to
oversee the overall federal effort, hold agencies accountable for their
individual efforts, adjust to changing conditions, and ensure
consistent and focused attention to the enforcement of prescription
drug importation laws.
Accordingly, our report recommends that the CBP Commissioner, in
concert with other agencies responsible for enforcing these laws,
develop and implement a strategic framework that, at a minimum,
includes establishing an approach to more reliably estimate the volume
of prohibited prescription drugs imported through international mail
and carrier facilities; determine resource needs and target resources
based on priorities; establish performance measures and milestones; and
evaluate progress, identify barriers to achieving goals, and suggest
modifications. DEA and ONDCP generally agreed with this recommendation.
DHS generally agreed with the contents of our report and said that CBP
is convening a task force meeting to discuss it. While generally
concurring with this recommendation, HHS questioned the need to include
an approach to estimate the volume of unapproved drugs entering the
country, believing its current estimates to be valid. We believe that
developing more systematic and reliable volume estimates might position
agencies to better define the scope of the problem so that decision
makers can make informed choices about resources. Considering FDA's
continuing concern about the statutory notification requirement, we
also recommend that the Secretary of HHS assess the ramifications of
removing or modifying the requirement, report the assessment results,
and, if appropriate, recommend changes to Congress. HHS generally
agreed with this recommendation; USPS noted that discussions of such
options must consider international postal obligations.
Background:
All international mail and packages entering the United States through
the U.S. Postal Service and private carriers are subject to potential
CBP inspection at the 14 USPS international mail facilities and 29
express consignment carrier facilities operated by private carriers
located around the country. CBP inspectors can target certain packages
for inspection or randomly select packages for inspection. CBP inspects
for, among other things, illegally imported controlled substances,
contraband, and items--like personal shipments of noncontrolled
prescription drugs--that may be inadmissible. CBP inspections can
include examining the outer envelope of the package, using X-ray
detectors, or opening the package to physically inspect the contents.
Each year the international mail and carrier facilities process
hundreds of millions of pieces of mail and packages. Among these items
are prescription drugs ordered by consumers over the Internet, the
importation of which is prohibited under current law, with few
exceptions.
Two acts--the Federal Food, Drug, and Cosmetic Act and the Controlled
Substances Import and Export Act--specifically regulate the importation
of prescription drugs into the United States. Under the Federal Food,
Drug, and Cosmetic Act, as amended, FDA is responsible for ensuring the
safety, effectiveness, and quality of domestic and imported drugs and
may refuse to admit into the United States any drug that appears to be
adulterated, misbranded, or unapproved for the U.S. market as defined
in the act.[Footnote 5] Under the act and implementing regulations,
this includes foreign versions of FDA-approved drugs if, for example,
neither the foreign manufacturing facility nor the manufacturing
methods and controls were reviewed by FDA for compliance with U.S.
statutory and regulatory standards. The act also prohibits
reimportation of a prescription drug manufactured in the United States
by anyone other than the original manufacturer of that drug. According
to FDA, prescription drugs imported by individual consumers typically
fall into one of these prohibited categories. However, FDA has
established a policy that allows local FDA officials to use their
discretion to not interdict personal prescription drug imports that do
not contain controlled substances under specified circumstances, such
as importing a small quantity for treatment of a serious condition,
generally not more than a 90-day supply of a drug not available
domestically.[Footnote 6] The importation of prohibited foreign
versions of prescription drugs like Viagra (an erectile dysfunction
drug) or Propecia (a hair loss drug), for example, would not qualify
under the personal importation policy because approved versions are
readily available in the United States.
In addition, the Controlled Substances Import and Export Act, among
other things, generally prohibits personal importation of those
prescription drugs that are controlled substances, such as Valium.
Under the act, shipment of controlled substances to a purchaser in the
United States from another country is only permitted if the purchaser
is registered with DEA as an importer and is in compliance with the
Controlled Substances Import and Export Act and DEA requirements. As
outlined in the act, it would be difficult, if not impossible, for an
individual consumer seeking to import a controlled substance for
personal use to meet the standards for registration and related
requirements.[Footnote 7]
CBP is to seize illegally imported controlled substances it detects on
behalf of DEA.[Footnote 8] CBP may take steps to destroy the seized and
forfeited substance or turn the seized substance over to other federal
law enforcement agencies for further investigation.[Footnote 9] CBP is
to turn over packages suspected of containing prescription drugs that
are not controlled substances to FDA.[Footnote 10] FDA investigators
may inspect such packages and hold those that appear to be adulterated,
misbranded, or unapproved, but must notify the addressee and allow that
individual the opportunity to present evidence as to why the drug
should be admitted into the United States.[Footnote 11] If the
addressee does not provide evidence that overcomes the appearance of
inadmissibility, then the item is refused admission and returned to the
sender.
Investigations that may arise from CBP and FDA inspections may fall
within the jurisdiction of other federal agencies. DEA, ICE, and FDA
investigators have related law enforcement responsibilities and may
engage in investigations stemming from the discovery of illegally
imported prescription drugs. Although USPS's Inspection Service does
not have the authority, without a federal search warrant, to open
packages suspected of containing illegal drugs, it may collaborate with
other federal agencies in certain investigations. Also, ONDCP is
responsible for formulating the nation's drug control strategy and has
general authority for addressing policy issues concerning the illegal
distribution of controlled substances. ONDCP's authority does not,
however, include prescription drugs that are not controlled substances.
The Volume of Prescription Drug Imports Is Unknown but Believed to Be
Substantial, and the Safety of These Drug Imports Is Not Assured:
My statement will now focus on what the available data show about the
volume and safety of prescription drugs imported into the United States
for personal use through the international mail and private carriers.
CBP and FDA Do Not Know the Scope of Prohibited Prescription Drug
Importation, but They Believe it to Be Substantial:
In our report, we state that CBP and FDA do not systematically collect
data on the volume of prescription drugs and controlled substances they
encounter at the mail and carrier facilities. CBP and FDA officials
have said that in recent years they have observed increasingly more
packages containing prescription drugs being imported through the mail
facilities, but neither agency has complete data to estimate the volume
of importation. FDA officials told us that CBP and FDA currently have
no mechanism for keeping an accurate count of the volume of illegally
imported drugs, because of the large volume of packages arriving daily
through the international mail and carriers. Furthermore, FDA officials
told us that FDA did not routinely track items that contained
prescription drugs potentially prohibited for import that they released
and returned for delivery to the recipient. However, they said that FDA
had begun gathering from the field information on the imported packages
it handles, but as of July 2005, this effort was still being refined.
We also report that CBP and FDA, in coordination with other federal
agencies, have conducted special operations targeted to identify and
tally the packages containing prescription drugs imported through a
particular facility during a certain time period and to generate
information for possible investigation. The limited data collected have
shown wide variations in volume. For example, at one mail facility CBP
officials estimated that approximately 3,300 packages containing
prescription drugs entered the facility in 1 week and at another mail
facility CBP officials estimated that 4,300 such packages entered the
facility in 1 day. While these data provide some insight regarding the
number of packages containing prescription drugs at a selected mail
facility during a certain time period, the data are not representative
of other time periods or projectable to other facilities.
Our report also notes that during congressional hearings over the past
4 years, FDA officials, among others, have presented estimates of the
volume of prescription drugs imported into the United States through
mail and express carrier facilities ranging from 2 million to 20
million packages in a given year. Each estimate has its limitations;
for example, some estimates were extrapolations from data gathered at a
single mail facility. More recently, a December 2004 HHS report stated
that approximately 10 million packages containing prescription drugs
enter the United States--nearly 5 million packages from Canada and
another 5 million mail packages from other countries.[Footnote 12]
However, these estimates also have limitations, being partially based
on extrapolations from limited FDA observations at international mail
branch facilities.[Footnote 13] Without an accurate estimate of the
volume of importation of prescription drugs, federal agencies cannot
determine the full scope of the importation issue.
The Safety of Prescription Drug Imports Is Not Assured:
Regarding the safety of prescription drug imports, we report that FDA
officials have said that they cannot provide assurance to the public
regarding the safety and quality of drugs purchased from foreign
sources, which are largely outside of their regulatory system. FDA
officials also said that consumers who purchase prescription drugs from
foreign-based Internet pharmacies are at risk of not fully knowing the
safety or quality of what they are importing. While some consumers may
purchase genuine products, others may unknowingly purchase counterfeit
products, expired drugs, or drugs that were improperly manufactured.
In addition, we report on CBP's and FDA's limited analysis of the
imported prescription drugs identified during special operations. The
results of these efforts have raised questions about the safety of some
of the drugs. For example, during a special operation in 2003 to
identify and assess counterfeit and potentially unsafe imported drugs
at four mail facilities, CBP and FDA inspected 1,153 packages that
contained prescription drugs.[Footnote 14] According to a CBP report,
1,019, or 88 percent, of the imported drug products were in violation
of the Federal Food, Drug, and Cosmetic Act or the Controlled
Substances Import and Export Act.
Consistent with these concerns, we report on the findings of our June
2004 report in which we identified several problems associated with the
handling, FDA approval status, and authenticity of 21 prescription drug
samples we purchased from Internet pharmacies located in several
foreign countries--Argentina, Costa Rica, Fiji, Mexico, India,
Pakistan, the Philippines, Spain, Thailand, and Turkey.[Footnote 15]
Our work showed that most of the drugs, all of which we received via
consignment carrier shipment or the U.S. mail, were unapproved for the
U.S. market because, for example, the labeling or the foreign
manufacturing facility, methods, and controls were not reviewed by FDA.
We observed during the site visits undertaken for our current report
that in addition to some prescription drugs imported through the mail
and carrier facilities not being shipped in protective packages, some
drugs also lacked product identifications, directions for use, or
warning labels. Furthermore, for some drugs, the origin and contents
could not be immediately determined by CBP or FDA inspection.
Highly Addictive Controlled Substances Are Widely Available via the
Internet:
Our report also noted that federal agencies and professional medical
and pharmacy associations have found that consumers of any age can
obtain highly addictive controlled substances from Internet pharmacies,
sometimes without a prescription or consultation with a physician. Both
DEA and ONDCP have found that the easy availability of controlled
substances directly to consumers over the Internet has significant
implications for public health, given the opportunities for misuse and
abuse of these addictive drugs. In addition, the American Medical
Association recently testified that Internet pharmacies that offer
controlled substances without requiring a prescription or consultation
with a physician contribute to the growing availability and increased
use of addictive drugs for nonmedical purposes.
Some Targeted Packages Containing Prescription Drugs Are Interdicted,
but Many Others Are Not:
My statement will now focus on the procedures and practices used at
selected facilities to inspect and interdict prescription drugs
unapproved for import.
New Procedures Should Encourage Uniform Practices, but They Still Allow
Many Packages Containing Prescription Drugs to Be Released:
With regard to procedures and practices used at selected facilities to
inspect and interdict prescription drugs unapproved for import, our
report cites our July 2004 testimony in which we reported that CBP and
FDA officials at selected mail and carrier facilities used different
practices and procedures to inspect and interdict packages that contain
prescription drugs.[Footnote 16] While each of the facilities we
visited targeted packages for inspection, the basis upon which packages
were targeted could vary and was generally based on several factors,
such as the inspector's intuition and experience, whether the packages
originated from suspect countries or companies, or were shipments to
individuals. At that time, we also reported that while some targeted
packages were inspected and interdicted, many others either were not
inspected and were released to the addressees or were released after
being held for inspection. FDA officials said that because they were
unable to process the volume of targeted packages, they released tens
of thousands of packages containing drug products that may violate
current prohibitions and could have posed a health risk to consumers.
In August 2004, FDA issued standard operating procedures outlining how
FDA personnel are to prioritize packages for inspection, inspect the
packages, and make admissibility determinations of FDA-regulated
pharmaceuticals imported into the United States via international mail.
Under the procedures, CBP personnel are to forward to FDA personnel any
mail items, from FDA's national list of targeted countries and based on
local criteria,[Footnote 17] that appear to contain prescription drugs.
Deviations from the procedures must be requested by facility personnel
and approved by FDA management. According to FDA officials, these
procedures have been adopted nationwide. While the new procedures
should encourage processing uniformity across facilities, many packages
that contain prescription drugs are still released. Specifically,
according to the procedures, all packages forwarded by CBP but not
processed by FDA inspectors at the end of each workday are to be
returned for delivery by USPS to the recipient. However, according to
the procedures, packages considered to represent a significant and
immediate health hazard may be held over to the next day for
processing.
Our report cites CBP and FDA officials at two facilities who told us
that the new procedures resulted in an increase in the number of
packages CBP personnel refer to FDA. Officials at one facility
estimated that CBP referrals have increased from approximately 500 to
an average of 2,000 packages per day. The FDA officials noted that the
procedures did not resolve the heavy volume of prescription drug
importation or FDA's ability to deal with the volume, nor were they
designed to do so. While the packages that are not targeted are
released without inspection, so are many packages that are targeted and
referred to FDA personnel. At one facility, FDA officials estimated
that each week they return without inspection 9,000 to 10,000 of the
packages referred to them by CBP. They said these packages were given
to USPS officials for delivery to the addressee.
New CBP Controlled Substances Policy May Improve Interdiction Efforts,
but Impact on Importation Is Unclear:
Regarding the procedures and practices used to inspect and interdict
certain controlled substances, our report cites our July 2004 testimony
in which we reported that CBP officials were to seize the illegally
imported controlled substances they detected.[Footnote 18] However, at
that time, some illegally imported controlled substances were not
seized by CBP. For example, CBP officials at one mail facility told us
that they experienced an increased volume of controlled substances and,
in several months, had accumulated a backlog of over 40,700 packages
containing schedule IV substances.
According to our report, CBP field personnel said they did not have the
resources to seize all the controlled substances they detected.
Officials said that the seizure process can be time-consuming, taking
approximately 1 hour for each package containing controlled substances.
According to CBP officials, when an item is seized, the inspector
records the contents of each package--including the type of drugs and
the number of pills or vials in each package. If the substance is a
schedule I or II controlled substance, it is to be summarily forfeited
without notice, after seizure. However, if it is a schedule III through
V controlled substance, CBP officials are to notify the addressee that
the package was seized[Footnote 19] and give the addressee an
opportunity to contest the forfeiture by providing evidence of the
package's admissibility and trying to claim the package at a forfeiture
hearing.[Footnote 20]
Our report goes on to say that to address the seizure backlog and give
CBP staff more flexibility in handling controlled substances, in
September 2004, CBP implemented a national policy for processing
controlled substances, schedule III through V, imported through the
mail and carrier facilities. According to the policy, packages
containing controlled substances should no longer be transferred to FDA
for disposition, released to the addressee, or returned to the sender.
CBP field personnel are to hold the packages containing controlled
substances in schedules III through V as unclaimed or abandoned
property as an alternative to a seizure.[Footnote 21] According to a
CBP headquarters official, processing a controlled substance as
abandoned property is a less arduous process because it requires less
information be entered into a database than if the same property were
to be seized. Once CBP deems the controlled substance to be unclaimed
property, the addressee is notified that he or she has the option to
voluntarily abandon the package or have the package seized. If the
addressee voluntarily abandons the package or does not respond to the
notification letter within 30 days, the package will be eligible for
immediate destruction. If the addressee chooses to have the package
seized, there would be an opportunity to contest the forfeiture and
claim the package, as described above. CBP also instituted an on-site
data collection system at international mail and express carrier
facilities to record schedule III through V controlled substances
interdicted using this new process.[Footnote 22] CBP reported that from
September 2004 to the end of June 2005, a total of approximately 61,700
packages of these substances were interdicted, about 61,500 at
international mail facilities and 200 at express carrier facilities.
We report that generally, CBP officials we interviewed told us that the
recent policy improved their ability to record information about and
destroy schedule III through V controlled substances they detected. A
CBP official at one facility said that the abandonment process is
faster than the seizure process, as it requires much less paperwork. A
CBP headquarters official told us that the abandonment process takes an
inspector at a mail facility about 1 minute to process a package. He
added that the new policy was intended to eliminate the backlog of
schedule III through V controlled substances at the facilities.
However, we also report that CBP officials in the field and in
headquarters said that they do not know whether the new policy has had
any impact on the volume of controlled substances illegally entering
the country that reach the intended recipient. Generally, CBP officials
do not know the extent of packages that contain controlled substances
that are undetected and released. For example, CBP officials at one
facility told us that they used historical data to determine the
countries that are likely sources for controlled substances and target
the mail from those countries. They do not know the volume of
controlled substances contained in the mail from the nontargeted
countries. A CBP official at another facility said that he believed the
volume of controlled substances imported through the facility had begun
to decrease, but he had no data to support his claim.
Packages Containing Prescription Drugs Can Bypass FDA Review at the
Carrier Facilities:
According to our report, packages containing prescription drugs can
also bypass FDA inspection at carrier facilities because of inaccurate
information about the contents of the package. Unlike packages at mail
facilities, packages arriving at carrier facilities we visited are
preceded by manifests, which provide information from the shipper,
including a description of the packages' contents. While the shipments
are en route, CBP and FDA officials are to review this information
electronically and select packages they would like to inspect when the
shipment arrives. FDA officials at two carrier facilities we visited
told us they review the information for packages described as
prescription drugs or with a related term, such as pharmaceuticals or
medicine. CBP and FDA officials told us that there are no assurances
that the shipper's description of the contents is accurate. The FDA
officials at the carrier facilities we visited told us that if a
package contains a prescription drug but is inaccurately described, it
would not likely be inspected by FDA personnel.
Factors beyond Inspection and Interdiction Complicate Efforts to
Enforce the Prohibitions on Personal Importation of Prescription Drugs:
My statement will now focus on the three factors that our report
identified as affecting federal agency efforts to enforce the
prohibition on prescription drug importation for personal use through
international mail and carrier facilities.
The Volume of Imports Can Strain Federal Resources:
In our report, we state that the current volume of prescription drug
imports, coupled with competing agency priorities, has strained federal
inspection and interdiction resources allocated to the mail facilities.
CBP and FDA officials told us that the recent increase in American
consumers ordering drugs over the Internet has significantly
contributed to increased importation of these drugs through the
international mail. CBP officials said that they are able to inspect
only a fraction of the large number of mail and packages shipped
internationally. FDA officials have said that the large volume of
imports has overwhelmed the resources they have allocated to the mail
facilities and they have little assurance that the available field
personnel are able to inspect all the packages containing prescription
drugs illegally imported for personal use through the mail. In
addition, agencies have multiple priorities, which can affect the
resources they are able to allocate to the mail and carrier facilities.
For example, FDA's multiple areas of responsibility include, among
other things, regulating new drug product approvals, the labeling and
manufacturing standards for existing drug products, and the safety of a
majority of food commodities and cosmetics, which, according to FDA
officials, all go to FDA's mission of protecting the public health
while facilitating the flow of legitimate trade. CBP's primary mission
is preventing terrorists and terrorist weapons from entering the United
States while also facilitating the flow of legitimate trade and travel.
DEA's multiple priorities include interdicting illicit drugs such as
heroin or cocaine, investigating doctors and prescription forgers, and
pursuing hijackings of drug shipments.
We also report on HHS and CBP assessments of resources needed to
address the volume of illegally imported drugs coming into the country.
In a 2004 report on the importation of prescription drugs, the
Secretary of HHS stated that substantial resources are needed to
prevent the increasing volume of packages containing small quantities
of drugs from entering the country.[Footnote 23] The Secretary found
that despite agency efforts, including those with CBP, FDA currently
does not have sufficient resources to ensure adequate inspection of the
current volume of personal shipments of prescription drugs entering the
United States. CBP is also in the early stages of assessing the
resources it needs at the mail facilities to address the volume of
controlled substance imports. However, CBP officials admit that an
assessment of resource needs is difficult because they do not know the
scope of the problem and the impact of the new procedures. A CBP
official told us that CBP has a statistician working on developing
estimates on the volume of drugs entering mail facilities; however, he
was uncertain whether this effort would be successful or useful for
allocating resources. Likewise, in March 2005, FDA officials told us
that they had begun to gather from the field information on the
imported packages it handles, such as the number of packages held,
reviewed, and forwarded for further investigation. However, as of July
2005, they could not provide any data because, according to the
officials, this effort was new and still being refined.
Internet Pharmacies Challenge Law Enforcement Efforts:
According to our report, Internet pharmacies, particularly foreign-
based sites, which operate outside the U.S. regulatory system, pose a
challenge for regulators and law enforcement agencies. In an earlier
2004 report, we described how traditionally, in the United States, the
practice of pharmacy is regulated by state boards of pharmacy, which
license pharmacists and pharmacies and establish and enforce standards.
To legally dispense a prescription drug, a licensed pharmacist working
in a licensed pharmacy must be presented a valid prescription from a
licensed health care professional. The Internet allows online
pharmacies and physicians to anonymously reach across state and
national borders to prescribe, sell, and dispense prescription drugs
without complying with state requirements or federal regulations
regarding imports.
In addition, we report that the nature of the Internet has challenged
U.S. law enforcement agencies investigating Internet pharmacies,
particularly foreign-based sites. Internet sites can easily be
installed, moved, or removed in a short period of time. This fluidity
makes it difficult for law enforcement agencies to identify, track,
monitor, or shut down those sites that operate illegally. Moreover,
investigations can be more difficult when they involve foreign-based
Internet sites, whose operators are outside of U.S. boundaries and may
be in countries that have different drug approval and marketing
approaches than the United States has. For example, according to DEA
officials, drug laws and regulations regarding controlled substances
vary widely by country. DEA officials told us their enforcement efforts
with regard to imported controlled substances are hampered by the
different drug laws in foreign countries. Internet pharmacy sites can
be based in countries where the marketing and distribution of certain
controlled substances are legal. Steroids, for example, sold over the
Internet may be legal in the foreign country in which the online
pharmacy is located. Federal agencies can also face challenges when
working with foreign governments to share information or develop
mechanisms for cooperative law enforcement. For example, FDA officials
have testified that they possess limited investigatory jurisdiction
over sellers in foreign countries and have had difficulty enforcing the
law prohibiting prescription drug importation when foreign sellers are
involved. A DEA official told us that it was difficult to convince some
foreign governments that the illegal sale of prescription drugs over
the Internet is a global problem and not restricted to the United
States.
In our report, we also note that FDA and DEA officials told us that
they work with commercial firms, including express carriers, credit
card organizations, Internet providers, and online businesses to obtain
information to investigate foreign pharmacies, but these investigations
are complicated by legal and practical considerations. FDA and DEA
officials said that the companies have been willing to work with
government agencies to stop transactions involving prescription drugs
prohibited from import, and some have alerted federal officials when
suspicious activity is detected. However, officials also identified
current legal and practical considerations that complicated obtaining
information from organizations, such as credit card organizations. For
example, according to FDA, DEA, and ICE officials, credit card
organizations[Footnote 24] and banks and other financial
institutions[Footnote 25] that issue credit cards will not provide to
the agencies information about the parties involved in the transaction
without a subpoena. Representatives from the credit card companies we
contacted explained that these issues generally are resolved if the
agency issues a properly authorized subpoena for the desired
information.[Footnote 26]
The Notification Process Challenges Enforcement Efforts:
We also report that FDA headquarters officials said that packages that
contain prescription drugs for personal use that appear to be
prohibited from import pose a challenge to their enforcement efforts
because these packages cannot be automatically refused. Before any
imported item is refused, the current law requires FDA to notify the
owner or consignee that the item has been held because it appears to be
prohibited and give the product's owner or consignee an opportunity to
submit evidence of admissibility. If the recipient does not respond or
does not present enough evidence to overcome the appearance of
inadmissibility, then the item can be returned to the sender, or in
some cases destroyed.
FDA officials told us that this requirement applies to all drug imports
that are held under section 801(a) of the Federal Food, Drug, and
Cosmetic Act. Nonetheless, they said that they believe this
notification process is time consuming because each package must be
itemized and entered into a database; a letter must be written to each
addressee; and the product must be stored. The process can take up to
30 days per import--and can hinder their ability to quickly handle
packages containing prescription drugs prohibited from import.
According to FDA investigators, in most instances, the addressee does
not present evidence to support the drugs' admissibility, and the drugs
are ultimately provided to CBP or the U.S. Postal Service for return to
sender. FDA headquarters officials told us that the Standard Operating
Procedures, introduced in August 2004 and discussed earlier in this
report, were an attempt to help FDA address the burden associated with
the notification process because the procedures were designed to focus
resources on packages containing drugs considered to be among the
highest risk.
Our report further indicates that FDA and the Secretary of HHS have
raised concerns about FDA's notification process, noting that it is
time-consuming and resource intensive, in testimony before Congress,
but did not propose any legislative changes to address the concerns
identified. In May 2001, FDA's Acting Principal Deputy Commissioner
wrote a memorandum to the Secretary of HHS expressing concern about the
growing number of drugs imported for personal use and the dangers they
posed to public health. The memorandum explained that because of the
notice and opportunity to respond requirements, detaining and refusing
entry of mail parcels was resource intensive. The Acting Principal
Deputy Commissioner proposed, among other things, the removal of the
requirement that FDA issue a notice before it could refuse and return
personal use quantities of FDA-regulated products that appear violative
of the Food, Drug, and Cosmetic Act. He noted that removal of the
notification requirement would likely require legislation, but without
this change, FDA could not effectively prohibit mail importation for
personal use. As of July 2005, according to FDA officials and an HHS
official, the Secretary had not responded with a specific legislative
proposal to change FDA's notification requirement. FDA officials said
that there are some complicating issues associated with eliminating the
notification requirement; for example, the importance of providing due
process, which basically gives individuals the opportunity to present
the case as to why they should be entitled to receive the property
(e.g., prescription drugs that they ordered from a foreign source),
and/or the extent the law should be changed to cover all imported
prescription drugs and other products. In addition, USPS indicated that
any discussion of options to expedite the processing and disposition of
prescription drugs must consider international postal obligations,
specifically the requirements of the Universal Postal Union (UPU). FDA
officials said that currently, the notification requirement also
applies to large commercial quantities of prescription drugs and other
nonpharmaceutical products for which the requirement is not a problem.
They said it has become a burden only because FDA and CBP are
overwhelmed with a large volume of small packages.
Furthermore, we report that FDA officials said that they have
considered other options for dealing with this issue, such as summarily
returning each package to the sender without going through the process.
However, they said that the law would likely need to be changed to
allow this, and, as with the current process, packages that are
returned to the sender could, in turn, be sent back by the original
sender to go through the process again. They said that another option
might be destruction, but they were uncertain whether they had the
authority to destroy drugs FDA intercepts; they indicated that the
authority might more likely lie with CBP. Regardless, FDA officials
said that whatever approach was adopted, FDA might continue to
encounter a resource issue because field personnel would still need to
open and examine packages to ascertain whether they contained
unapproved prescription drugs.
Federal Efforts to Coordinate Law Enforcement Activities Could Benefit
from a Strategic Framework:
My statement will now focus on efforts federal agencies have undertaken
to coordinate the enforcement of the prohibitions on personal
importation of prescription drugs.
Federal Agencies Have Recently Begun to Coordinate Efforts to Focus on
Prescription Drugs Imported for Personal Use:
According to our report, since 1999, federal law enforcement and
regulatory agencies have organized various task forces and working
groups to address issues associated with purchasing prescription drugs
over the Internet; however, recent efforts have begun to focus
particular attention on imported prescription drugs. For example,
according to an FDA official, many of FDA's efforts, started in 1999,
focused on Internet pharmaceutical sales by illicit domestic pharmacies
and the risks associated with purchasing those drugs, rather than drugs
that are being imported from foreign countries. As our report
discusses, more recent efforts have focused on prescription drugs
entering international mail and express carrier facilities.
In January 2004, the CBP Commissioner initiated an interagency task
force on pharmaceuticals, composed of representatives from CBP, FDA,
DEA, ICE, and ONDCP as well as legal counsel from the Department of
Justice. According to the Commissioner, the proposal to create the task
force was prompted by "intense public debate and congressional
scrutiny, which has resulted in increasing pressure being applied to
regulatory and law enforcement agencies to develop consistent, fair
policies" to address illegal pharmaceuticals entering the United
States. The Commissioner proposed that the task force achieve five
specific goals, and according to a CBP official, five working groups
were established to achieve these goals. Figure 1 shows the task force
goals, the five working groups, and the goals of each working group.
Figure 1: Interagency Pharmaceutical Task Force and Working Group
Goals:
[See PDF for image]
[End of figure]
CBP officials and other members of the task force provided examples of
activities being carried out or planned by task force working groups.
For example, the working group on mail and express consignment operator
facilities procedures has carried out special operations at five
international mail and three express carrier facilities to examine
parcels suspected of containing prohibited prescription drugs over
specific periods of time, such as 2 or 3 days. While similar operations
have occurred since 2000, a CBP official told us that those conducted
under the task force are multiagency efforts; they are expected to
continue during the remainder of 2005 at all of the remaining mail
facilities and some of the carrier facilities. Our report describes
activities of the other working groups.
In addition, we report that the task force members are working with
ONDCP to address the importation of controlled substances through
international mail and carrier facilities. In October 2004, ONDCP
issued a plan for addressing demand and trafficking issues associated
with certain man-made controlled substances--such as pain relievers,
tranquilizers, and sedatives.[Footnote 27] Among other things, ONDCP
recommended that DEA, CBP, ICE, State Department, National Drug
Intelligence Center, and FDA work with USPS and private express mail
delivery services to target illegal mail order sales of chemical
precursors, synthetic drugs, and pharmaceuticals, both domestically and
internationally. ONDCP officials said that a multiagency working group
is meeting to discuss what can be done to confiscate these controlled
substances before they enter the country.
Finally, we report that USPS is exploring what additional steps it can
take to further help the task force. USPS officials said that they
proposed, during a July 2004 hearing, the possibility of cross-
designating U.S. Postal Inspectors with Customs' authority so that
Postal Inspectors can conduct warrant-less searches, at the border, of
incoming parcels or letters suspected of containing illegal drugs.
According to USPS officials, such authority would facilitate
interagency investigations. They said that their proposal has yet to be
finalized with CBP. In addition, internationally, USPS has drafted
proposed changes to the U.S. listing in the Universal Postal Union List
of Prohibited Articles.[Footnote 28] This action is still pending.
A Strategic Framework Would Further Enhance Task Force Efforts:
In our report, we state that although the task force has taken positive
steps toward addressing issues associated with enforcing the laws on
personal imports, it has not fully developed a strategic framework that
would allow the task force to address many of the challenges we
identify in this report. Our review showed that the task force has
already begun to establish some elements of a strategic framework, but
not others. For example, the Commissioner's January 2004 memo laid out
the purpose of the task force and why it was created. However, it has
not defined the scope of the problem it is trying to address because,
as discussed earlier, CBP and FDA have yet to develop a way to estimate
the volume of imported prescription drugs entering specific
international mail and carrier facilities. In addition, while the task
force and individual working groups have goals that state what they are
trying to achieve, the task force has not established milestones and
performance measures to gauge results. Furthermore, the task force has
not addressed the issue of what its efforts will cost so that it can
target resources and investments, balancing risk reduction with costs
and considering task force members' other law enforcement priorities.
Instead, according to a CBP official, working group projects are done
on an ad hoc basis wherein resources are designated for specific
operations.
Carrying out enforcement efforts that involve multiple agencies with
varying jurisdictions is not an easy task, especially since agencies
have limited resources and often conflicting priorities. According to
our report, the challenges we identify could be more effectively
addressed by using a strategic framework that more clearly defines the
scope of the problem by estimating the volume of drugs entering
international mail and carrier facilities, establishes milestones and
performance measures, determines resources and investments needed to
address the flow of imported drugs entering the facilities and where
those resources and investments should be targeted, and evaluates
progress. Advancing such a strategic framework could establish a
mechanism for accountability and oversight. Our report acknowledges
that such a strategic framework needs to be flexible to allow for
changing conditions and could help agencies adjust to potential changes
in the law governing the importation of prescription drugs for personal
use.
GAO Conclusions, Recommendations, and Agency Responses:
While acknowledging the complexities of enforcing the laws governing
prescription drug imports for personal use, including the involvement
of multiple agencies with various jurisdictions and differing
priorities, our report concludes that current inspection and
interdiction efforts at the international mail branches and express
carrier facilities have not prevented the reported substantial and
growing volume of prescription drugs from being illegally imported from
foreign Internet pharmacies into the United States. CBP and other
agencies have taken a step in the right direction by establishing a
task force designed to address many of the challenges discussed in this
report. However, a strategic framework that facilitates comprehensive
enforcement of prescription drug importation laws and measures results
would provide the task force with an opportunity to better focus agency
efforts to stem the flow of prohibited prescription drugs entering the
United States. In addition to the issues addressed by the task force,
FDA has also expressed continuing concern to Congress that it
encounters serious resource constraints enforcing the law at mail
facilities because packages containing personal drug imports must be
handled in accordance with FDA's time-consuming and resource-intensive
notification process. FDA has stated that it cannot effectively enforce
the law unless the requirement to notify recipients is changed.
Accordingly, to help ensure that the government maximizes its ability
to enforce laws governing the personal importation of prescription
drugs, our report recommends that the CBP Commissioner, in concert with
ICE, FDA, DEA, ONDCP, and USPS, develop and implement a strategic
framework for the task force that would promote accountability and
guide resource and policy decisions. At a minimum, this strategic
framework should include:
* establishment of an approach for estimating the scope of the problem,
such as the volume of drugs entering the country through mail and
carrier facilities;
* establishment of objectives, milestones, and performance measures and
a methodology to gauge results;
* determination of the resources and investments needed to address the
flow of prescription drugs illegally imported for personal use and
where resources and investments should be targeted; and:
* an evaluation component to assess progress, identify barriers to
achieving goals, and suggest modifications.
In view of FDA's continuing concern about the statutory notification
requirement and its impact on enforcement, our report also recommends
that the Secretary of HHS assess the ramifications of removing or
modifying the requirement, report on the results of this assessment,
and, if appropriate, recommend changes to Congress.
In commenting on our report, DEA and ONDCP generally agreed with our
recommendation that the CBP task force develop a strategic framework.
DEA agreed that such a framework needs to be flexible to allow for
changing conditions and said DEA will, in concert with other task force
agencies, support the CBP Commissioner's strategic framework for the
interagency task force. DHS generally agreed with the contents of our
report and said that CBP is convening a task force meeting to discuss
our recommendation. While generally concurring with our recommendation
for a strategic framework, HHS questioned the need to include an
approach for estimating the volume of unapproved drugs entering the
country, because it believed its current estimates are valid. HHS also
said our statement that the task force agencies could develop
statistically valid volume estimates and realistic risk-based estimates
of the number of staff needed to interdict parcels at mail facilities
did not recognize FDA's current level of effort at these facilities
relative to its competing priorities. We believe that developing more
systematic and reliable volume estimates might position agencies to
better define the scope of the problem so that decision makers can make
informed choices about resources, especially in light of competing
priorities. Regarding our recommendation to assess the ramifications of
removing or modifying FDA's statutorily required notification process,
HHS generally agreed and stated that it intended to pursue an updated
assessment. USPS did not state whether it concurred with our
recommendations, but it noted that discussions of options to expedite
the processing and disposition of prescription drugs must consider
international postal obligations.
Mr. Chairman, this concludes my prepared testimony. I would be happy to
respond to any questions you or other members of the committee may have
at this time.
GAO Contacts and Staff Acknowledgments:
For further information about this testimony, please contact me at
(202) 512-8816. John F. Mortin, Leo M. Barbour, Frances A. Cook,
Katherine M. Davis, Michele C. Fejfar, and Barbara A. Stolz made key
contributions to this statement.
[End of section]
Related GAO Products:
Prescription Drugs: Strategic Framework Would Promote Accountability
and Enhance Efforts to Enforce the Prohibitions on Personal
Importation. GAO-05-372. Washington, D.C.: September 8, 2005.
Prescription Drugs: Preliminary Observations on Efforts to Enforce the
Prohibitions on Personal Importation. GAO-04-839T. Washington, D.C.:
July 22, 2004.
Internet Pharmacies: Some Pose Safety Risks for Consumers. GAO-04-820.
Washington, D.C.: June 17, 2004.
Internet Pharmacies: Some Pose Safety Risks for Consumers and Are
Unreliable in Their Business Practices. GAO-04-888T. Washington, D.C.:
June 17, 2004.
Combating Terrorism: Evaluation of Selected Characteristics in National
Strategies Related to Terrorism. GAO-04-408T. Washington, D.C.:
February 2004.
FOOTNOTES
[1] See GAO, Prescription Drugs: Strategic Framework Would Promote
Accountability and Enhance Efforts to Enforce the Prohibitions on
Personal Importation, GAO-05-372 (Washington, D.C.: September 8, 2005).
[2] The Controlled Substances Act establishes a classification
structure for certain drugs and chemicals that are designated as
controlled substances. This structure places such substances in one of
five schedules, based on their medicinal value, risk to public health,
and potential for abuse and addiction, among other factors. Schedule I
is reserved for the most dangerous drugs that have no currently
accepted medical use, such as heroin and ecstasy. Controlled substances
that may be prescribed by a physician or used in medical facilities
fall in schedules II through V (e.g., Valium). For certain law
enforcement purposes, however, schedule II drugs are treated more like
schedule I drugs.
[3] See GAO, Internet Pharmacies: Some Pose Safety Risks for Consumers,
GAO-04-820 (Washington, D.C.: June 17, 2004) and GAO, Internet
Pharmacies: Some Pose Safety Risks for Consumers and Are Unreliable in
Their Business Practices, GAO-04-888T (Washington, D.C.: June 17,
2004).
[4] UPU is a specialized agency of the United Nations governing
international postal services. According to the USPS, the Universal
Postal Convention establishes a general rule that undeliverable items
are to be returned to sender. UPU regulations provide that where an
item can neither be delivered to the addressee nor returned to the
sender, the Postal Service must notify the postal administration of
origin of how the item was dealt with, including indicating the
prohibition under which the item falls. USPS noted that this is
particularly important with respect to registered or insured mail for
which the Postal Service can be held financially responsible if it is
not delivered or returned.
[5] An unapproved drug includes one that has not been demonstrated to
be safe and effective and for which the manufacturing facility,
methods, and controls have not been shown to meet FDA standards.
Failure to meet other statutory and regulatory standards relating to
labeling, handling, and packaging may result in a drug being considered
adulterated or misbranded. See 21 U.S.C. §§ 351, 352, 355.
[6] According to the policy, other conditions should be met as well,
such as (1) provision of the name and address of the doctor licensed in
the United States responsible for the importer's treatment with the
product or evidence that the product is for continuation of treatment
begun in a foreign country and (2) the absence of any known
commercialization or promotion to persons residing in the United States
by those involved in the distribution of the product at issue.
Alternatively, in the case of a drug that is not for a serious
condition, the policy also permits FDA officials to use their
discretion to allow importation of that drug if the intended use is
identified and the product is not known to represent a significant
health risk. A complete description of FDA's personal importation
policy can be found in chapter 9 of FDA's Regulatory Procedures Manual,
which is available on the agency's Web site.
[7] The act and implementing regulations permit an individual traveler
under certain circumstances to carry a personal use quantity of a
controlled substance (except a substance in schedule I) across the U.S.
border, but they do not make a similar exception for importation by
mail or private carrier.
[8] See 19 U.S.C. § 1595a(c)(1)(B); 19 C.F.R. §§ 162.23, 145.59,
145.58, 12.36. Controlled substances in schedules I and II are subject
to summary forfeiture without notice, but those in schedule III through
V are not.
[9] See 19 C.F.R. §§ 162.31, 162.32, 162.45, 162.45a, 162.46, 162.47,
162.63.
[10] See 21 U.S.C. § 381(a); 19 C.F.R. §§ 12.1(a), 145.57; see also
Chapter 9 of FDA's Regulatory Procedures Manual, Subchapter Coverage of
Personal Importations, "Mail Shipments"
http://www.fda.gov/ora/compliance_ref/rpm_new2/ch9pers.html.
[11] See 21 U.S.C. § 381(a); 21 CFR §1.94.
[12] HHS Task Force on Drug Importation, Report on Prescription Drug
Importation, Department of Health and Human Services, December 2004.
[13] FDA officials told us that FDA developed its estimate for Canadian
drugs entering the country using (1) IMS Health estimates (IMS Health
is a management consulting firm that provides information to
pharmaceutical and health care industries) that 12 million
prescriptions sold from Canadian pharmacies were imported into the
United States in 2003 and (2) FDA's experience during special
operations at various locations from which it concluded that there
appeared to be about 2.5 prescriptions in each package. According to
FDA officials, the estimate for other countries was an extrapolation
using the estimated 5 million packages from Canada in conjunction with
FDA's observations, likewise made during special operations, that 50
percent of the mail packages enter from countries other than Canada.
[14] According to CBP officials, packages shipped through four mail
facilities were examined over a 3-day period. Approximately 100 parcels
(each of which may have contained multiple drug products) per day per
facility were selected based upon their country of origin and CBP's
historical experience.
[15] GAO-04-820 and GAO-04-888T.
[16] See GAO, Prescription Drugs: Preliminary Observations on Efforts
to Enforce the Prohibitions on Personal Importation, GAO-04-839T
(Washington, D.C.: July 22, 2004).
[17] Local criteria can include other targeted countries and additional
intelligence.
[18] GAO-04-839T.
[19] The seized package could also be submitted to ICE for possible
investigation of the addressee and the sender.
[20] Since schedule I and schedule II controlled substances are subject
to summary forfeiture without notice, there is no opportunity to
contest the forfeiture of these drugs.
[21] Under the policy, unless accompanied by a valid DEA Import Permit
or DEA Declaration, schedules I and II controlled substances are to be
seized pursuant to 19 U.S.C § 1595a(c)(1)(B) and processed in
accordance with established seized asset procedures.
[22] CBP officials emphasized that these data only include schedule III
through V controlled substances interdicted through its new process and
do not include those schedule III through V controlled substances
seized. According to a CBP headquarters official, the number of
interdictions made using the controlled substance policy implemented on
September 1, 2004, refers to single packages, because these detentions
are almost all personal use quantities. In contrast, CBP seizure data
for schedules III, IV, and V controlled substances are most likely
commercial shipments and, therefore, could include multiple packages.
[23] HHS Task Force on Drug Importation, Report on Prescription Drug
Importation, Department of Health and Human Services, December 2004.
The Medicare Prescription Drug, Improvement, and Modernization Act of
2003 directed the Secretary of Health and Human Services, in
consultation with appropriate government agencies, to conduct a study
of the importation of drugs into the United States, including,
according to the conference report for the legislation, a review of the
adequacy of federal agency resources to inspect and interdict drugs
unapproved for import, and submit a report to Congress. Pub. L. No. 108-
173, § 1122, 117 Stat. 2066, 2469 (2003), H.R. Conf. Rep. No. 105- 39,
at 833-34 (2003).
[24] Two types of credit card organizations handle the four major U.S.
credit cards. Credit card associations, such as Visa and MasterCard,
license their member banks to issue bank cards, authorize merchants to
accept those cards, or do both. In contrast, full-service credit card
companies, such as American Express and Discover, issue their own
brands of cards directly to customers and authorize merchants to accept
those cards. See also GAO, Money Laundering: Extent of Money Laundering
through Credit Cards Is Unknown, GAO-02-670 (Washington, D.C.: July 22,
2002), and Internet Gambling: An Overview of the Issues, GAO-03-89
(Washington, D.C.: December 2, 2002).
[25] When banks and financial institutions, rather than the credit card
company, have the direct relationship with the merchants and credit
cardholders, the former are the primary source of transactional
information needed for law enforcement purposes.
[26] According to a DEA official, the majority of Internet drug sites
used the payment systems of the two associations we contacted.
[27] ONDCP, National Synthetic Drugs Action Plan: The Federal
Government Response to the Production, Trafficking, and Abuse of
Synthetic Drugs and Diverted Pharmaceutical Products (Washington D.C;
October 2004). According to ONDCP, the Action Plan is to provide a
blueprint for action under the President's National Drug Control
Strategy and "focuses primarily on illicitly manufactured synthetic
drugs which are not of primarily organic origin" and "selected
pharmaceutical products which are sometimes diverted from legitimate
commerce."
[28] The Universal Postal Union List of Prohibited Articles is a
listing of articles prohibited for importation into the United States,
as well as other member countries of the UPU. The listing is shared
with foreign postal administrations to enable them to educate their
customers on country prohibitions for international mail.