Prescription Drugs
Preliminary Observations on Efforts to Enforce the Prohibitions on Personal Importation Gao ID: GAO-04-839T July 22, 2004American consumers are increasingly drawn to the convenience, privacy, and cost advantages that might be accrued by purchasing prescription drugs over the Internet. However, there is growing concern about the safety of the drugs and the lawfulness of shipping the drugs into the United States through international mail and private carriers. Under current law, the importation of prescription drugs for personal use is illegal, with few exceptions. 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. According to the agencies responsible for enforcing these laws, prescription drugs imported for personal use generally do not meet these requirements. The Department of Homeland Security's U.S. Customs and Border Protection (CBP) and the Department of Health and Human Service's Food and Drug Administration (FDA) are responsible for inspecting and interdicting unapproved prescription drugs that are being illegally imported via the U.S. mail or private carrier. This testimony reflects our preliminary observations from ongoing work to assess federal efforts to enforce the prohibitions on personal importation of prescription drugs.
CBP and FDA officials said that the volume of imported adulterated, misbranded, or unapproved prescription drugs is large and increasing, but complete data do not exist to document these observations. FDA officials said 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. GAO's recent report on a sample of drugs purchased from Internet pharmacies echoed these concerns. CBP and FDA officials at mail and private carrier facilities inspect and interdict some packages that contain prescription drugs. However, according to officials, because of resource constraints, many other packages containing prescriptions drugs are either not inspected and are released to addressees or are released after an inspection. CBP and FDA target certain packages for inspection based on the packages' countries of origin and whether the packages are suspected of containing certain prescription drugs. However, packages that are not targeted typically bypass inspection and are released to addressees without an assessment of their contents or admissibility. FDA officials have acknowledged that tens of thousands of packages, containing drug products that may violate current laws and pose health risks to consumers, have been released. They said that time-consuming processing requirements and resource constraints limit their ability to perform more inspections. Agency efforts to deal with imported prescription drugs are evolving. Two interagency task forces were established to study prescription drug importation and address related law enforcement issues, respectively. Also, to overcome differences in the way officials target and interdict shipments of unapproved prescription drugs at various mail and private carrier facilities, FDA has begun implementing new procedures to promote more uniformity across facilities. It is too soon to tell if these efforts are sufficient to address various health, safety, and law enforcement issues associated with the importation of prescription drugs.
GAO-04-839T, Prescription Drugs: Preliminary Observations on Efforts to Enforce the Prohibitions on Personal Importation
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Testimony:
Before the Permanent Subcommittee on Investigations, Committee on
Governmental Affairs, U.S. Senate:
United States Government Accountability Office:
GAO:
For Release on Delivery Expected at 9: 00 a.m. EDT:
Thursday, July 22, 2004:
PRESCRIPTION DRUGS:
Preliminary Observations on Efforts to Enforce the Prohibitions on
Personal Importation:
Statement of Richard M. Stana, Director, Homeland Security and Justice
Issues:
GAO-04-839T:
GAO Highlights:
Highlights of GAO-04-839T, a testimony before the Permanent
Subcommittee on Investigations, Committee on Governmental Affairs, U.S.
Senate
Why GAO Did This Study:
American consumers are increasingly drawn to the convenience, privacy,
and cost advantages that might be accrued by purchasing prescription
drugs over the Internet. However, there is growing concern about the
safety of the drugs and the lawfulness of shipping the drugs into the
United States through international mail and private carriers. Under
current law, the importation of prescription drugs for personal use is
illegal, with few exceptions. 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.
According to the agencies responsible for enforcing these laws,
prescription drugs imported for personal use generally do not meet
these requirements. The Department of Homeland Security‘s U.S. Customs
and Border Protection (CBP) and the Department of Health and Human
Service‘s Food and Drug Administration (FDA) are responsible for
inspecting and interdicting unapproved prescription drugs that are
being illegally imported via the U.S. mail or private carrier.
This testimony reflects our preliminary observations from ongoing work
to assess federal efforts to enforce the prohibitions on personal
importation of prescription drugs.
What GAO Found:
CBP and FDA officials said that the volume of imported adulterated,
misbranded, or unapproved prescription drugs is large and increasing,
but complete data do not exist to document these observations. FDA
officials said 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. GAO‘s recent report on a sample of
drugs purchased from Internet pharmacies echoed these concerns.
CBP and FDA officials at mail and private carrier facilities inspect
and interdict some packages that contain prescription drugs. However,
according to officials, because of resource constraints, many other
packages containing prescriptions drugs are either not inspected and
are released to addressees or are released after an inspection. CBP and
FDA target certain packages for inspection based on the packages‘
countries of origin and whether the packages are suspected of
containing certain prescription drugs. However, packages that are not
targeted typically bypass inspection and are released to addressees
without an assessment of their contents or admissibility. FDA officials
have acknowledged that tens of thousands of packages, containing drug
products that may violate current laws and pose health risks to
consumers, have been released. They said that time-consuming processing
requirements and resource constraints limit their ability to perform
more inspections.
Agency efforts to deal with imported prescription drugs are evolving.
Two interagency task forces were established to study prescription drug
importation and address related law enforcement issues, respectively.
Also, to overcome differences in the way officials target and interdict
shipments of unapproved prescription drugs at various mail and private
carrier facilities, FDA has begun implementing new procedures to
promote more uniformity across facilities. It is too soon to tell if
these efforts are sufficient to address various health, safety, and law
enforcement issues associated with the importation of prescription
drugs.
Packages suspected of containing imported prescription drugs awaiting
FDA review:
[See PDF for image]
[End of figure]
www.gao.gov/cgi-bin/getrpt?GAO-04-839T.
To view the full product, including the scope and methodology, click on
the link above. For more information, contact Richard Stana at (202)
512-8777 or Stanar@gao.gov.
[End of section]
Mr. Chairman and Members of the Subcommittee:
I appreciate the opportunity to be here today to participate in this
hearing on prescription drug importation. American consumers are
increasingly drawn to the convenience, privacy, and cost advantages
that might be accrued by purchasing over the Internet such prescription
drugs as Valium, cholesterol-lowering drugs, and Viagra. However, there
is growing concern, reported in the media and elsewhere, that persons
who purchase prescription drugs from Internet pharmacies, particularly
those pharmacies located in foreign countries, run the risk of taking
drugs that may be compromised or not the authentic product they
intended to purchase. Thus, American consumers may be exposed to
potential health and safety risks. Furthermore, consumers may also be
violating the law, unknowingly or intentionally, by having these drugs
shipped into the United States through the international mail and
private carriers.
Under current law, the importation of prescription drugs for personal
use is illegal, with few exceptions. 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, as defined in the Controlled Substances Act,[Footnote 1]
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.
My testimony today reflects our preliminary observations from ongoing
work to assess federal efforts to enforce the prohibitions on personal
importation of prescription drugs, which was requested by the Chairman
and Ranking Minority Member of this Subcommittee and the Ranking Member
of the House Energy and Commerce Committee. Much of our work to date
has focused on the efforts of the Department of Homeland Security's
U.S. Customs and Border Protection (CBP) and the Department of Health
and Human Service's Food and Drug Administration (FDA) to inspect and
interdict prescription drugs that are being imported via the U.S. mail
or private carrier, such as FedEx or DHL, for personal use. In this
statement, I make the following points:
* CBP and FDA officials said that the amount of unapproved prescription
drugs illegally entering the country is large and increasing. The
overall healthfulness and safety of these imported drugs is not
assured, and limited testing showed that some of these drugs pose risks
to consumers.
* CBP and FDA interdict some packages that contain prescription drugs,
but many other packages containing these drugs are released to
addressees--either not inspected and released or released after
inspection. According to CBP and FDA officials, this is because of
resource and other constraints.
* CBP and FDA officials told us that their respective requirements for
inspecting and processing violative materials can be time-consuming and
in some cases hamper their enforcement efforts.
* Agency efforts to address issues concerning the importation of
prescription drugs are evolving, but it is still too early to tell
whether these efforts will adequately address every aspect of the law
enforcement and safety issues associated with the importation of these
drugs.
My testimony is based on our ongoing review of federal laws and agency
policies, procedures, and practices related to personal importation of
prescription drugs; visits to three international mail facilities
operated by the U.S. Postal Service and two private carrier facilities;
and interviews with officials from CBP, FDA, the Department of
Justice's Drug Enforcement Administration (DEA), the U.S. Postal
Service, and the Department of Homeland Security's U.S. Immigration and
Customs Enforcement. We did the work reflected in this statement from
March to July 2004 in accordance with generally accepted government
auditing standards. We plan to finish our work and issue a report later
this year. Additional information on our scope and methodology can be
found in appendix I.
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 13 International Mail Branches (IMBs) located at
U.S. Postal Service 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 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 IMBs 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 2] Under the act and implementing regulations,
this includes foreign versions of FDA-approved drugs because, 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 permit personal importation of prescription drugs that do
not contain controlled substances under specified circumstances, such
as importing for treatment of a serious condition a small quantity,
generally not more than a 90-day supply, of a drug not available
domestically.[Footnote 3] The importation of unapproved 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 also controlled substances, such as Valium
or codeine. (See app. II for general description of controlled
substances.) Under the act, the importation of controlled substances is
prohibited unless the importer is registered with DEA, and such
registration is generally not available for importation for personal
use. 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.[Footnote 4]
CBP inspects packages for prescription drugs on behalf of DEA and FDA.
Upon inspection, CBP is to seize illegally imported controlled
substances on behalf of DEA.[Footnote 5] 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 6] CBP is to turn over packages suspected of
containing prescription drugs that are not controlled substances to
FDA.[Footnote 7] 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 8] If the addressee does not provide evidence that
overcomes the appearance of inadmissibility, then the item is refused
admission.
Figure 1 illustrates the two acts that specifically govern the
importation of prescription drugs into the United States. It also
presents the roles of FDA, DEA, and CBP in implementing those acts.
Figure 1: Acts Governing the Personal Importation of Prescription Drugs
into the United States and FDA, DEA, and CBP Roles Implementing Those
Acts:
[See PDF for image]
[End of figure]
Volume of Prescription Drug Imports Is Said to be Large and Increasing,
and the Health and Safety of these Drug Imports is Not Assured:
CBP and FDA officials said that the volume of unapproved prescription
drugs illegally imported through the IMBs or carrier facilities is
large and steadily increasing. However, complete data do not exist to
document this observation. During special operations, CBP and FDA have
attempted to determine the volume of imported prescription drugs
entering through selected IMBs. Generally, these were one-time,
targeted efforts to identify and tally all of the packages containing
prescription drugs at certain time periods. The limited data collected
have shown wide variations in volume. For example, CBP officials at one
IMB estimated that approximately 3,300 packages containing prescription
drugs entered the facility in one week. In 2004, CBP officials at
another IMB determined that 4,300 packages containing prescription
drugs entered the facility in one day. While these data may provide
estimates regarding the volume entering selected IMBs for certain time
periods, the data may not be representative of other time periods or
projectable to other locations.
FDA officials have stated 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.
Additionally, FDA officials indicated 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.
FDA officials also have stated that while some consumers may purchase
genuine products, others may unknowingly purchase counterfeit products,
expired drugs, or drugs that were improperly manufactured.
CBP and FDA have conducted special operations to do limited assessments
of the nature of some imported prescription drugs, and these operations
have raised questions about the safety of some of the drugs analyzed.
For example, during an operation undertaken in 2003 at four IMBs, CBP
and FDA inspected 1,153 packages that contained prescription
drugs.[Footnote 9] According to a CBP report, 1,019, or 88 percent, of
the drug products were violative because they were prohibited for
import, including Lipitor (a cholesterol-lowering drug), Viagra, and
Propecia. A CBP laboratory analyzed 180 drug samples. This analysis
showed that the majority of the drugs were never approved by FDA.
Furthermore, the operation showed that many of the unapproved drugs
could pose safety risks. The samples included drugs that were withdrawn
from the U.S. market for safety reasons; animal drugs not approved for
human use; and drugs that carry risks because they require careful
dosing, initial screening, or periodic patient monitoring. In addition,
other drugs tested were found to contain controlled substances
prohibited for import, and some of the drugs contained no active
ingredients. Figure 2 illustrates the results of the CBP laboratory
analysis.
Figure 2: Results of CBP's Laboratory Analysis of 180 Imported Drugs:
[See PDF for image]
[End of figure]
In a recent report and testimony before this Subcommittee, we found
that prescription drugs ordered from some foreign-based Internet
pharmacies posed safety risks for consumers.[Footnote 10] Specifically,
we identified several problems associated with the handling, FDA
approval status, and authenticity of 21 prescription drugs samples
purchased from Internet pharmacies located in several foreign
countries--Argentina, Costa Rica, Fiji, Mexico, India, Pakistan,
Philippines, Spain, Thailand, and Turkey. Our work showed that most of
these drug samples, 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[Footnote 11] or the foreign manufacturing
facility, methods, and controls were not reviewed by FDA. Of the 21
samples:
* None included dispensing pharmacy labels that provided instructions
for use, and only about one-third included warning information.
* Thirteen displayed problems associated with the handling of the drug;
three samples that should have been shipped in a temperature-controlled
environment arrived in envelopes without insulation; and five samples
contained tablets enclosed in punctured blister packs, potentially
exposing them to damaging light or moisture.
* Two were found to be counterfeit versions of the products we ordered,
and two had a significantly different chemical composition than that of
the product we had ordered.
We found fewer problems among 47 samples purchased from U.S. and
Canadian Internet pharmacies. Although most of the drugs obtained from
Canada were of the same chemical composition as that of their U.S.
counterparts, most were unapproved for the U.S. market. We stated that
it was notable that we identified numerous problems among the samples
received despite the relatively small number of drugs we purchased,
consistent with problems recently identified by state and federal
regulatory agencies.
Some Packages Containing Prescription Drugs Are Interdicted, but Others
Are Released:
Our work thus far shows that while CBP and FDA interdicted some
packages that contain prescription drugs, other similar packages were
released--either not inspected and released or released after
inspection. CBP officials told us that certain packages were targeted
for inspection. However, packages that were not targeted typically
bypass inspection and are released to the addressee without an
assessment of their contents or admissibility. Many packages that were
held by CBP officials for FDA at the IMBs were also subsequently
released to the addressee. FDA has acknowledged that tens of thousands
of packages have been released, although they may contain drug products
that violate current laws and pose health risks to consumers. FDA
officials at the IMBs said that the packages were released to the
addressee because FDA investigators were unable to process the volume
of packages turned over to them. FDA headquarters officials told us
that this occurred because of limited available resources relative to
the volume of unapproved prescription drugs entering the country.
Packages Not Targeted for Inspection and Released:
According to CBP and FDA officials at the IMBs we visited, CBP and FDA
use various approaches to target certain incoming international mail
packages for inspection. These include targeting packages from certain
countries and/or packages suspected of containing certain prescription
drugs. For example, at one IMB we visited, FDA provided CBP with a list
of targeted countries--the composition of which changed periodically. A
recent list targeted seven countries and specific areas in one other
country. FDA officials asked that CBP hold the packages they suspected
of containing prescription drugs that were from the targeted countries.
Typically, CBP officials told us that when packages containing
prescription drugs were detected, but were not from one of the targeted
countries, they were released to the addressee without an assessment of
their admissibility. Accordingly, CBP officials stated that packages
containing prescription drugs unapproved for import were released daily
without FDA review.
According to CBP and FDA officials at the carrier facilities we
visited, packages containing prescription drugs sent through these
facilities may also be released without inspection. Unlike packages at
IMBs, packages arriving at carrier facilities we visited were preceded
by advance manifest information, which included the shipper's
declaration describing the contents and its value. CBP and FDA
officials review the manifest information to target packages for
inspection before their arrival. Agency officials at two carrier
facilities we visited told us that FDA officials were not typically on-
site and electronically reviewed the manifests and targeted incoming
packages declared as prescription drugs. FDA officials noted that
packages containing prescription drugs could potentially avoid their
review if the manifest information was not accurate. CBP and FDA
officials told us there were no assurances that the shipper's
declarations were accurate. For example, CBP and FDA officials at the
carrier facility found eight packages containing a human growth
hormone--unapproved for import--that were inaccurately manifested as
glassware.
Packages Released after Inspection:
FDA officials said that some packages that were inspected and
determined to contain prescription drugs at the IMBs were released
because they could not process them. For example, at one IMB, CBP
officials held 16 bins containing roughly 3,000 packages for FDA
investigators on a weekly basis. However, the FDA officials estimated
that in one week, they could open and fully inspect about 140 packages.
In making the decision regarding what to inspect, two FDA investigators
considered whether the packages contained prescription drugs considered
to be an enforcement priority, including injectable drugs and certain
controlled substances, such as steroids. The FDA officials told us that
they typically released packages that did not contain a priority drug,
even though the packages were believed to contain other prescription
drugs that were not approved for import. Figure 3 shows bins containing
packages of suspected prescription drugs being held for FDA review and
possible inspection.
Figure 3: Bins Containing Packages of Suspected Prescription Drugs
Being Held for FDA Review and Possible Inspection.
[See PDF for image]
[End of figure]
At another IMB, CBP officials said that they usually released packages
containing prescription drugs that appeared to be a 90-day supply or
less--in line with one of the criteria in FDA's personal importation
policy.[Footnote 12] For example, after viewing an x-ray image of a
package, CBP performed a visual inspection of the outer container of a
medication, labeled as a treatment for ulcers,[Footnote 13] determined
that it appeared to contain 90 pills, and released it. At this same
facility, FDA officials told us that every week CBP turned over to FDA
hundreds of packages. CBP told us that these packages contained
quantities of prescription drugs that appeared to be more than a 90-day
supply. However, the FDA officials stated that they were able to
process a total of approximately 20 packages per day. As a result, the
FDA officials told us they returned many of the packages to CBP, citing
an inability to process every package. The CBP officials said that most
of the returned packages were released to the addressees. For example,
CBP officials told us that several packages suspected of containing
generic Viagra, unapproved for import, were returned by FDA and were
released.
Officials Said Process Requirements Are Time-Consuming and Can Hamper
Enforcement Effort:
FDA officials told us that for packages found to contain prescription
drugs, processing requirements are time-consuming and can hamper their
ability to process all of the packages that are detained by CBP. FDA
processing requirements include identifying the drugs, measuring the
volume, entering this information into a FDA database, taking pictures
of the drugs, preparing the drugs for temporary storage, and sending
notification to the addressees to provide evidence regarding the
admissibility of the drug. Processing time varies depending on the
quantity and variety of drugs in the package.
In addition, processing time increases if research is required to
determine the drug type. For example, FDA officials at one IMB stated
that some prescription drugs are not immediately identifiable,
particularly when shipped without labels or with labels in a foreign
language. Figure 4 illustrates an example of drugs that was sent
without labeling.
Figure 4: Drugs Sent without Labeling.
[See PDF for image]
[End of figure]
FDA officials at the IMBs we visited stated that considering these many
factors, processing a single package can take anywhere from a few
minutes to several hours. FDA officials who are responsible for
reviewing manifest information for drugs shipped through the private
carriers stated that it can take several days to process a package,
particularly if they need to obtain additional information regarding
the shipment.
FDA headquarters officials said that packages that contain prescription
drugs that appear to be unapproved for import cannot be automatically
refused and returned because of the statutory requirement that FDA hold
the package and give the addressee the opportunity to provide evidence
of admissibility. Officials said that this requirement applies to all
drug imports with few exceptions. According to FDA investigators, in
most instances, the addressees did not present evidence to support the
drugs' admissibility, and the drugs were ultimately provided to CBP or
the U.S. Postal Service for return to sender.
CBP officials at two IMBs told us that they could not turn over all
packages they suspected of containing prescription drugs because FDA
officials were not able to process all of the packages. FDA officials
at one IMB stated that the processing time affected the number of
packages they could inspect and was the reason many of the packages
that were held up by CBP were ultimately released to the addressee
without inspection. A FDA headquarters official stated that
considerable storage space is needed to hold the detained packages,
while the notice, opportunity to respond, and the agency's decision are
pending. For example, one FDA IMB official told us that space
limitations have affected the number of packages they are able to
store, including those packages held on-site awaiting a response from
the addressee. Figure 5 shows drugs stored at one IMB as they pass
through FDA's process, including those awaiting addressees' responses.
Figure 5: Drugs in Storage as They Pass through FDA's Process at One
IMB:
[See PDF for image]
[End of figure]
Processing requirements for controlled substances can also be
burdensome if an IMB receives a high volume of controlled substances in
the mail. According to CBP officials, the seizure process requires that
CBP inspectors record the contents of each package--including the type
of drugs and the number of pills or vials in each package--before it is
turned over to seized property staff for possible investigation by
Immigration and Customs Enforcement, forfeiture, and eventual
destruction. CBP officials at one IMB told us that in recent months
they have observed substantial increases in the volume of prescription
drugs containing controlled substances being sent through the
international mail because, in their view, of the increased incidence
of consumers ordering drugs over the Internet. Although CBP officials
had been seizing substantially more of these drugs in recent months,
they had also accumulated a sizable backlog of controlled substances
awaiting seizure because, according to officials, they did not have the
resources to begin the seizure process. By June 2004, CBP at this IMB
had accumulated 123 bins of mail, containing over 40,700 packages of
Schedule IV controlled substances--including the tranquilizer Valium,
antidepressants, and painkillers. Figure 6 shows some of the bins of
controlled substances that were being held awaiting formal seizure, as
of May 14, 2004.
Figure 6: Controlled Substances Accumulated and Awaiting Seizure at One
IMB:
[See PDF for image]
[End of figure]
According to CBP officials at this facility, as the controlled
substances continued to accumulate, they became concerned that they
would not be able resolve the backlog. In June, a CPB official said
that CBP IMB officials asked CBP headquarters for permission to send
the products back to the senders as an alternative to seizure, and to
keep these drugs from entering U.S. commerce. According to this
official, CBP's headquarters office granted them permission to send
most of the drugs back to the sender because the backlog would have
taken months to resolve.[Footnote 14] One CBP official said that the
ability to return the controlled substances enabled CBP to clear the
backlog in two to three weeks rather than the one to two years they
projected it would have taken had CBP been required to begin seizure
proceedings for each item. Officials at the facility said that they are
now seizing controlled substances as they arrive at the facility.
Agency Efforts to Address the Importation of Prescription Drugs Are
Evolving:
Our preliminary work revealed a number of efforts, including
interagency initiatives that are being undertaken in response to
concerns raised about the importation of prescription drugs. For
example, 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 and submit a report
to Congress (P.L. 108-173). The conference report (House Report 108-
391) enumerated questions to be addressed in this study including,
among other things:
* assessing the scope, volume, and safety of unapproved drugs,
including controlled substances, entering the United States via mail
shipment; and:
* estimating agency resources, including additional field personnel,
needed to adequately inspect the current amount of pharmaceuticals
entering the country.
In February 2004, the Secretary of Health and Human Services appointed
a task force, chaired by the Surgeon General, on drug importation. It
included members representing the department, CBP, DEA, Department of
Justice trial attorneys, and the Office of Management and Budget.
Between March and May, the task force held public hearings to gather
information to address the questions posed by Congress. According to an
FDA official, as of July 2004, the task force staff was reviewing the
testimony from the public hearings and the comments sent to the Federal
Register docket to answer the questions posed in the conference report.
The official said that the task force report is expected to be
completed by this fall so that the Secretary of Health and Human
Services can meet his December 2004 deadline for reporting to Congress.
In addition, a CBP official told us that CBP is leading an interagency
pharmaceutical task force, established in January 2004 to address
various law enforcement issues related to the importation of
prescription drugs and miscellaneous pharmaceuticals. The task force,
which includes managers and senior managers from CBP, FDA, DEA, the
Office of National Drug Control Policy, U.S. Immigration and Customs
Enforcement, as well as legal counsel from the Department of Justice
and other agencies, meets every two months. According to the CBP
official, the task force has established five interagency working
groups designed to tackle specific issues identified by the task force.
The working groups, which meet more frequently, are focused on
improving information sharing and law enforcement targeting criteria,
increasing public awareness of potential dangers of imported
pharmaceuticals, reviewing and enhancing mail and express mail
consignment procedures, working cooperatively with industry, and legal
issues. The groups report the results of their enforcement efforts to
the task force, which makes suggestions for future efforts.
Our preliminary discussions with CBP about the activities of the
working groups revealed initiatives currently under way by two of the
groups. In one instance, the working group on mail and express mail
consignment procedures has been involved in recent interagency
enforcement operations at selected international mail facilities.
During these operations, the interagency group targeted and found mail
containing nonscheduled prescription drugs as well as controlled
substances. According to the CBP official, these operations resulted in
investigations of commercial shipments of the prescription drugs by
agents from the task force and working group and helped the law
enforcement agencies identify Internet addresses for purposes of future
investigations. The CBP official told us that, in another instance, the
working group focused on increasing public awareness of the potential
dangers of imported pharmaceuticals had developed public service
announcements that are to be posted on the Internet. Appendix III shows
one of these announcements that was recently posted on the CBP web
site.
Individual agencies are also taking steps to enhance their ability to
deal with inspection and interdiction issues associated with imported
prescription drugs. As discussed earlier, during our visits to the
three IMBs, we noted that CBP and FDA officials at those facilities had
adopted different approaches for targeting and interdicting
prescription drugs. FDA headquarters officials also recognized this and
in response indicated that a more uniform approach was needed.
According to these officials, FDA has drafted a set of standard
operating procedures that will apply to the handling of imported
prescription drugs consistently across the 13 International Mail
Branches. FDA officials said that these procedures have been developed
to apply to the handling of prescription drugs nationwide, but will
also give officials at individual facilities some flexibility to adopt
procedures that address uniquely local conditions. FDA headquarters
officials told us they have begun implementing the procedures at
selected IMBs and plan to implement them at more locations. FDA
officials also said that they were developing a similar set of standard
operating procedures that would apply to the inspection and
interdiction of imported prescription drugs at the consignment carrier
facilities. CBP officials told us that CBP expects that these
guidelines will also discuss CBP responsibilities for handling imported
prescription drugs.
In closing, Mr. Chairman, it has been discussed in the media and
elsewhere that American consumers are purchasing prescription drugs for
importation in increasing numbers. Our preliminary observations
indicate that CBP and FDA face considerable challenges inspecting and
interdicting these drugs to help ensure compliance with current law.
Currently data are unavailable to estimate the volume of prescription
drugs entering the country, and the overall health and safety risks of
these drugs are unknown. CBP and FDA are inspecting and interdicting
some of the unapproved prescription drugs that are entering the
country, but others bypass inspection and are sent to consumers who
purchased them, often because, according to CBP and FDA officials,
time-consuming processing requirements and staffing constraints limit
their ability to perform more inspections. Although agencies like CBP,
FDA, and DEA have begun initiatives to deal with various aspects of the
drug importation issue, it is too early to tell whether these efforts
will adequately address every dimension of the law enforcement and
safety issues associated with the importation of prescription drugs.
This concludes my prepared statement. In the next several weeks we plan
to follow up with CBP and FDA officials on their plans to enhance their
enforcement activities. I would be pleased to answer any questions you
and the Subcommittee members may have.
GAO Contacts and Staff Acknowledgments:
For further information about this testimony, please contact Richard
Stana, Director, Homeland Security and Justice Issues, on (202) 512-
8777 or at stanar@gao.gov. Major contributors to this testimony
included John Mortin, Yelena Harden, Barbara Stolz, Frances Cook, and
James Russell.
[End of section]
Appendix I: Scope And Methodology:
To understand importation restrictions and enforcement requirements, we
reviewed current federal laws on the importation of prescription drugs
and controlled substances. We reviewed current CBP and FDA policies,
procedures, and guidance related to prescription drugs and controlled
substance importation. We reviewed applicable importation and
interdiction data from CBP and FDA. We conducted interviews with
officials at CBP, FDA, U.S. Postal Service, U.S. Immigration and
Customs Enforcement, and DEA.
To understand inspection procedures, we visited three IMBs in Chicago,
Los Angeles, and New York and two carrier facilities in Cincinnati (for
the DHL Corporation) and in Memphis, (for the FedEx Corporation). We
judgmentally selected these facilities based on the overall number of
packages processed at the facilities and their geographic dispersion.
At these locations, we observed inspection and interdiction practices;
met with CBP and FDA management, inspectors, and investigators to
discuss issues related to inspection, manifest reviews, and
pharmaceutical importation volume; and reviewed relevant documents on
inspection and interdiction procedures. At the IMBs we also met with
officials from the U.S. Postal Service regarding mail handling and
processing procedures.
We did the work reflected in this statement from March to July 2004 in
accordance with generally accepted government auditing standards.
[End of section]
Appendix II: General Description of the Controlled Substance Schedules
I-V:
The drugs and drug products that come under the Controlled Substances
Act are divided into five schedules. A general description and examples
of the substances in each schedule are outlined below in table 1.
Table 1: General Description of Controlled Substance Schedules I-V:
Schedule: I;
Description of substances in the schedule: Substances that have no
accepted medical use in the United States and have a high potential
for abuse;
Examples: Heroin, lysergic acid diethylamide (LSD), marijuana, and
gama hydroxybutyric acid (GHB).
Schedule: II;
Description of substances in the schedule: Substances that have a high
potential for abuse with severe psychic or physical dependence
liability--certain narcotic, stimulant, and depressant drugs;
Examples: Opium, morphine, codeine, methadone, and meperidine
(Demerol).
Schedule: III;
Description of substances in the schedule: Substances that have a
potential for abuse that is less than those in Schedules I and II and
include compounds containing limited quantities of certain narcotic
drugs and non-narcotic drugs;
Examples: Anabolic steroids; derivatives of babituric acid (except
those listed in another schedule); benzphetamine; and any compound,
mixture, preparation or suppository dosage form containing
amobarbital, secobarbital, or pentobarbital.
Schedule: IV;
Description of substances in the schedule: Substances that have a
potential for abuse that is less than those listed in Schedule III;
Examples: Barbital, alprazolam (Xanax), Cathine-- constituent of the
"Khat" plant, and Diazepam (Valium).
Schedule: V;
Description of substances in the schedule: Substances that have a
potential for abuse that is less than those listed in Schedule IV and
consist primarily of preparations containing limited quantities of
certain narcotic and stimulant drugs;
Examples: Pyrovalerone (Centroton, Thymergix).
Source: GAO analysis of Drug Enforcement Administration information.
Note: Schedule I substances are not the subject of this report.
[End of table]
[End of section]
Appendix III: CBP Public Service Announcement Posted on the Internet:
[See PDF for image]
[End of image]
[End of section]
FOOTNOTES
[1] The Controlled Substances Act establishes a classification
structure for certain drugs and chemicals that are designated as
controlled substances. This structure places controlled 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.
Prescription drugs that are also controlled substances, such as Valium
or codeine, fall in schedules II through V.
[2] 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. §§ 811, 812 §§ 351, 352, 355.
[3] 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.
[4] 21 U.S.C. 956(a), 957(b)(1)(C); 21 C.F.R. 1301.26. The controlled
substance must be in the original container in which it was dispensed
to the individual. The individual must declare that it is possessed for
personal use or for an accompanying animal and provide the trade or
chemical name and schedule of the substance. If the traveler is a U.S.
resident, he or she may bring no more than 50 dosage units of the
substance without a prescription.
[5] 19 USC § 1595a(c)(1)(B); 19 C.F.R. §§ 162.23, 145.59, 145.58,
12.36. Schedule I and II controlled substances are subject to summary
forfeiture.
[6] 19 CFR §§ 162.31, 162.32, 162.45, 162.45a, 162.46, 162.47, 162.63.
[7] 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. Downloaded May 18, 2004.
[8] 21 U.S.C. § 381(a); 21 CFR §1.94.
[9] According to CBP officials, packages shipped through four IMBs 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 historical experience.
[10] See U.S. General Accounting Office, Internet Pharmacies: Some Pose
Safety Risks for Consumers, GAO-04-820 (Washington, D.C.: June 17,
2004) and U.S. General Accounting Office, Internet Pharmacies: Some
Pose Safety Risks for Consumers and Are Unreliable in Their Business
Practices, GAO-04-888T (Washington, D.C.: June 17, 2004).
[11] The term "labeling" is broader than the term "label" and includes
all labels and other written, printed, or graphic matter upon an
article or its container or wrapper, or that accompanies the article.
See 21 U.S.C. § 321(m).
[12] For a description of some of the other criteria in FDA's personal
importation policy, see note 3 and the accompanying text.
[13] This medication was labeled as a Canadian drug, although it had a
New Zealand return address.
[14] According to a CBP official, most of the drugs returned were
Schedule IV controlled substances. They said that a small number of the
packages contained nonschedule prescription drugs that were referred to
FDA. Also, CBP seized a small number of items that did not have a
return address.
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