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INTRODUCTION
Mr. Chairman and Members of the Committee, I am
William K. Hubbard, Senior Associate Commissioner for Policy, Planning and
Legislation, Food and Drug Administration (FDA or the Agency). I appreciate the
opportunity to discuss our mutual concerns related to the importation of drugs
into the United States (U.S.). This topic encompasses a range of issues,
including the importation by individuals of prescription drugs at land borders
or through the mail; the introduction into the U.S. of controlled substances
from foreign sources under the guise of personal importation; the potential
introduction of counterfeit bulk drugs into the U.S. drug supply; and the
purchase of drugs from foreign sources over the Internet. We appreciate the
leadership this Committee has taken in keeping these issues at the forefront.
Let me begin by discussing one of our greatest challenges in this area.
PERSONAL IMPORTATION OF DRUGS THROUGH THE MAIL
The amount of prescription drugs for personal use
imported through the mail has increased in recent years. According to testimony
by the U.S. Customs Service (Customs) before the
Government Reform Committee in May of last year,
seizures of parcels containing scheduled or controlled substances at
international mail facilities increased by 450 percent in FY 1999, primarily due
to drug sales over the Internet. We estimate that approximately two million
parcels containing FDA-regulated products for personal use enter the U.S. each
year through international mail facilities that Customs could set aside for FDA
review for possible
violations of the Federal Food, Drug, and
Cosmetic (FD&C) Act. This estimate is based on an extrapolation of data
obtained during a pilot project conducted at the international mail facility in
Carson, California (see below).
Under the FD&C Act, unapproved, misbranded,
and adulterated drugs are prohibited from importation into the U.S., including
foreign versions of U.S.-approved medications, as is reimportation of approved
drugs made in the U.S. In general, all drugs imported by individuals fall into
one of these prohibited categories.
From a public health standpoint, importing
prescription drugs for personal use is a potentially dangerous practice. FDA and
the public do not have any assurance that unapproved products are effective or
safe, or have been produced under U.S. good manufacturing practices.
U.S.-made drugs that are reimported may not have
been stored under proper conditions,
or may not be the real product, because the U.S.
does not regulate foreign distributors or pharmacies. Therefore, unapproved
drugs and reimported approved medications may be contaminated, subpotent,
superpotent, or counterfeit. In addition, some foreign web sites offer to
prescribe medicines without a physical examination, bypassing the traditional
doctor-patient relationship. As a result, patients may receive inappropriate
medications because of misdiagnoses, or fail to receive appropriate medications
or other medical care, or take a product that could be harmful, or fatal, if
taken in combination with other medicines they might be taking.
Personal Importation Policy
Under FDA’s personal importation policy, as
described in guidance to the Agency’s field personnel, FDA inspectors may
exercise enforcement discretion to permit the importation of certain unapproved
prescription medication for personal use.
First adopted in 1954, the policy has been
modified several times over the succeeding years. It was last modified in 1988,
in response to concerns that certain potentially effective treatments for AIDS
patients were not available in the U.S., but were available in other countries.
The Agency expanded the guidance for humanitarian purposes to allow individuals
suffering from serious medical conditions to acquire medical treatments legally
available in foreign countries but not approved in the U.S.
The current policy permits the exercise of
enforcement discretion to allow entry of an unapproved prescription drug if:
the product is for personal use (a 90-day supply
or less, and not for resale);
the intended use is for a serious condition for
which effective treatment may not be available domestically (and, therefore, the
policy does not permit inspectors to allow foreign versions of U.S.-approved
drugs into the U.S.);
there is no known commercialization or promotion
to U.S. residents by those involved in the distribution of the product;
the product is considered not to represent an
unreasonable risk; and
the individual seeking to import the product
affirms in writing that it is for the patient's own use and provides the name
and address of the U.S. licensed doctor responsible for his or her treatment
with the product or provides evidence that the product is for the continuation
of a treatment begun in a foreign country.
FDA has not officially permitted the importation
of foreign versions of U.S.-approved medications, even if sold under the same
name, because these products are unapproved, and the Agency has no assurance
that these products are safe or effective, while safe and effective versions are
already available in the U.S.
FDA believes that the need for its personal
importation policy is far less now than it was when the current version of the
policy was developed in 1988. Now, due to faster review times and various
regulatory mechanisms through which patients can obtain unapproved treatments
for humanitarian purposes, the need to import therapies not available in the
U.S. has diminished. According to a Tufts University study presented in
September 2000, 80 percent of new molecular entities approved in the U.S. in
1996 through 1998 received that approval within a year of its first introduction
on the world market, almost double the rate during the years 1991 through 1995.
Implementation of the Personal Importation Policy
At mail facilities, Customs officials identify
parcels that may be violative of the FD&C Act. FDA inspectors then determine
if these products should or should not be permitted to enter the country. If
detained, FDA must issue a notice to the addressee describing the potential
Federal violation and provide the individual with an opportunity to respond. If
the addressee does not respond or provides an inadequate response, FDA will give
the parcel back to Customs to have it returned to the exporter. Due to the
requirements for notice and the opportunity to respond, the process for
detaining and further processing mail parcels consumes large amounts of FDA
resources. In addition, much storage space would be
needed to hold the large number of detained
parcels pending replies from the addressees.
FDA’s personal importation policy, as written,
is difficult to implement. This is due, at
least in part, to the difficulty faced by FDA
inspectors, or even health care practitioners, in identifying a medicine by its
appearance, and labeling may falsely identify a product. From
a practical standpoint, FDA inspectors cannot
examine drug products contained in a mailed parcel and accurately determine the
identity of such drugs or the degree of risk posed to the individual who will
receive these drugs.
FDA detains and refuses few mail imports for
personal use. As a consequence, the tens of thousands of parcels that FDA does
not review are eventually released by Customs and sent on to their addressees,
even though the products contained in these parcels may appear to violate the
FD&C Act and may pose a health risk to consumers. We do not believe this is
an acceptable public health outcome and are working to develop a solution.
HHS Plan to Address Mail Imports for Personal Use
Due to the inability of FDA to cope with the
volume of medications imported for personal use through the mail, and because of
the public health risks associated with these products (as discussed below), FDA
has been working to develop a more effective personal importation policy. In
addition, we recognize that Customs is dependent on guidance from FDA, and one
of our goals is to provide clear and simple standards for assessing parcels
containing drug products. We are discussing options for revisions to the Agency’s
personal importation policy with Secretary Thompson.
Carson Mail Facility Pilot
Earlier this year, FDA and Customs conducted a
survey of imported drug products entering the U.S. through the Carson City,
California mail facility (the Carson pilot). The Carson pilot was proposed by
Customs as a means to examine incoming mail shipments of pharmaceutical products
over a specified time frame in order to identify both the volume and the types
of drug products entering the U.S. We also hoped to better assess the efforts
required to cover drug importations at a mail facility, and to gain a better
understanding of the public health implications these importations may have for
U.S. consumers.
The Carson pilot ran for a five-week period, with
FDA inspectors present for 40 hours per week. At the onset, Customs took a
"baseline" sample in the first week by setting aside all international
packages that were suspect, or that they would have set aside for FDA review had
FDA been able to process them. The number of packages set aside was
approximately 3,300. Multiplying that number by five weeks provides an estimated
total of 16,500 international packages (650 packages per day) that Customs could
have set aside for FDA review during the Carson pilot, if the ability to process
them was not a factor. After the first week, however, Customs actually set aside
the number of packages they believed FDA would be able to examine. In general,
during each week of the Carson pilot, more packages were set aside than FDA was
able to handle.
FDA was actually able to examine 1,908 packages
during the five-week pilot, an average of approximately 381 packages per week.
Neither FDA nor Customs kept a count of the packages that were set aside but not
examined. Unexamined packages were sent on to the addressees.
Of the 1,908 packages examined by FDA, 721
parcels were detained and the addressees notified that the products appeared to
be unapproved for use in the U.S., misbranded and/or a drug requiring a doctor’s
prescription. The parcels were shipped from a total of 19 countries, and
overall, there was no obvious evidence of the products being imported for
further commercial distribution. On average, the Agency was detaining at a rate
of 144 packages per week, or about 38 percent of those examined.
Clearly, the Carson pilot demonstrated that the
rate of packages coming into the U.S. exceeds FDA’s capacity to manage, thus,
Customs is left with little choice but to forward the majority of packages to
addressees. As we stated, we do not believe this is an acceptable public health
outcome, and we are working to develop a solution.
Analysis of the Carson Pilot Drug Parcels
In order to define better the nature of the risk
to public health from the types of products coming into the U.S. through
personal importation, FDA’s Center for Drug Evaluation and Research (CDER)
reviewed listings of the products detained during the Carson pilot. CDER’s
review demonstrates that there are serious public health risks associated with
many of the 721 drug shipments (composed of 197 different drugs) intercepted at
Carson. In general, there are two types of risks that consumers of these drugs
would face. The first type of risk is that associated with taking drugs of
unknown origin or quality. Second are the very significant risks associated with
taking many of these drugs without first obtaining a physician’s prescription
and without the continued oversight of the physician.
Risks Associated with Drugs of Unknown Origin or
Quality
In general, FDA has no information to establish
where these drugs were actually manufactured and whether necessary current Good
Manufacturing Practice requirements were followed. There is also no assurance
that the drugs were packaged and stored under appropriate conditions to avoid
degradation or contamination.
Approximately eight percent of the shipments
contained drugs that could not be identified because they contained no labeling;
some of these contain only foreign language labeling. Most of these drug
shipments were contained in plastic bags; one shipment contained drugs taped
between magazine pages.
Several drugs do not appear to correspond with
any U.S.-approved drugs and the risks are therefore difficult to assess. One
drug was evaluated for FDA approval but was denied approval. This drug is
associated with cardiac abnormalities and its efficacy could not be successfully
demonstrated. Another drug approved abroad but not in the U.S. is associated
with medically serious gastro-intestinal complications. Several shipments
contained three drugs that were once approved by FDA but have been withdrawn
from the market based on serious safety concerns, including:
fatal arrhythmia and dangerous drug interactions;
loss of white blood cells (agranulocytosis)
associated with fatal infections; and
hemorrhagic stroke.
Risks Associated with the Absence of Physician
Oversight
The vast majority of the shipments were
identified as containing prescription drugs, which by definition, have serious
toxicities and risks associated with them such that they are "not safe for
use except under the supervision of a practitioner licensed by law to administer
such drug." (Title 21, United States Code, section 353(b)). Although
some foreign Internet sites might offer an online questionnaire, we believe that
very few, if any, require a prescription from a practitioner licensed in the
U.S. before dispensing such drugs to U.S. residents. Moreover, after detention
notices were issued to the intended recipients of the 721 drug shipments, fewer
than four percent presented evidence of prescriptions to document their
relationship with a physician in association with the drugs purchased from
abroad. The lack of adequate English language labeling accompanying many of
these shipments exacerbates the risks associated with the absence of physician
oversight.
During the Carson pilot, as in normal practice,
Customs generally separated out controlled substances for processing by the Drug
Enforcement Administration (DEA) before the remaining shipments were provided
for FDA review. However, in FDA’s review, six controlled substances were
identified, including lorazepam, codeine sulfate, loperamide, chlordiazepoxide,
chloral hydrate, and diphenoxylate. These drugs have the potential to cause
addiction or be abused. Life-threatening overdoses are possible. A physician’s
prescription and oversight are essential for managing these risks.
There are numerous drugs identified on the Carson
list that are intended to treat conditions that consumers need physicians to
properly diagnose. As a result, consumers who bypass physician diagnosis and
prescribing may be exposing themselves to risks and toxicities that cannot be
justified by offsetting benefits to those patients.
For example, almost ten percent of the shipments
were for antibiotics, despite the fact that consumers are generally not able to
diagnose whether their symptoms are caused by bacterial infections. The overuse
of antibiotics continues to be a serious public health concern because it is
linked to the growth of antibiotic resistant-bacteria.
Several drugs listed are potent steroids, which
are generally prescribed for conditions that are not self-diagnosable. In
addition, potential adverse events associated with these drugs, including
diabetes, hypertension, and serious infection require prompt attention and
careful monitoring.
There are many drugs on the list for which it is
essential that the proper dose be delivered into the bloodstream at the proper
rate. Some of these drugs have a narrow range in which they can safely achieve
their therapeutic effect. At least seven such drugs were identified on the
Carson list. Without FDA oversight, there is the risk that these drugs may not
have been manufactured with the necessary quality controls to ensure a
consistently safe and effective product.
One seizure medication on the Carson list, for
which there were three shipments, could be very dangerous if not manufactured to
these rigorous standards. Any change in potency could render the drug
ineffective or highly toxic.
Another seizure drug on the list for which
physician monitoring is also essential has a narrow therapeutic range and FDA
labeling provides a black-box warning for hepatoxicity, teratogenicity, and
pancreatitis.
More than 30 drugs on the list have serious
contraindications and/or drug interactions for which physician oversight is
essential. For instance, almost 20 percent of the shipments were for various
estrogen products for which there are multiple serious contraindications that a
physician needs to consider before making prescribing decisions and in
monitoring the patient.
It is impossible to make a scientifically
definitive statement on the public health impact of the drug shipments
encountered during the Carson pilot without extensive chemical testing and
analysis of the incoming pharmaceuticals, which would be prohibitively
expensive. Based on the observations noted above, however, FDA believes that
these drugs pose substantial risks to the public health, and we further believe
that significant changes to the policies governing personal importations through
the mail are warranted.
Border Surveys
Over the last year, FDA has initiated three other
surveys to gather data on drug products imported by individuals into the U.S.
Although these border surveys involve land traffic rather than mail importation,
the results of these surveys show some similarities to the findings from the
Carson mail pilot, as well as some significant differences.
Southwest Border Survey (August 2000)
A survey of prescription drugs being brought by
pedestrians into the U.S. at eight ports of entry along the 2,000 mile border
with Mexico was conducted by FDA’ s Southwest Import District (SWID) with the
assistance of other agencies including Customs, the DEA, the U.S. Department of
Agriculture, and others. The survey looked at activity during four hours on a
Saturday (August 12, 2000) at eight border ports in California, Arizona, and
Texas. The purpose of the survey was to interview individuals walking across the
border into the U.S. from Mexico who had purchased prescription drugs in Mexico
to determine 1) what specific types of products are being imported, and 2) who
is importing these products.
The data collected from over 600 interviews
indicated that the most common importer of prescription drugs during the survey
was an older male Caucasian with a prescription from the U.S., bringing back
primarily antibiotics or pain relievers for his own use. Prescriptions were held
by 63 percent of the persons interviewed (59 percent U.S. prescriptions and 41
percent Mexican). The most common drugs and their indications that were
purchased in Mexico during the survey were as follows: Amoxicillin (antibiotic),
Glucophage (diabetes),
Premarin (estrogen), Dolo Neurobion (vitamin
supplement), Vioxx (inflamation), Retin-A (acne), Tafil (anxiety), Celebrex
(arthritis), Penicillin (antibiotic), Viagra (impotence), Carisoprodal
(analgesic).
Canadian Border Survey
On January 6, 2001, in cooperation with Customs,
FDA conducted a survey to obtain a snapshot of prescription drug products being
brought into the U.S. from Canada via passenger vehicles. During the eight-hour
survey at three ports of entry in New York, Michigan and Washington, a total of
10,374 passenger vehicles and 58 buses crossed into the U.S. Of these, 33
passenger vehicles (35 individuals) were referred by Customs to be interviewed.
These individuals brought in a total of 47 containers of drug products from
Canada.
The types of products included pain medicines --
primarily "222" (a combination of acetaminophen, caffeine, and
codeine) or similar products. The indicated reason for import was that the
products were available over the counter in Canada and cost less than in the
U.S. The next largest group of products was herbal products, with the reason for
importation being that the products were not available in the U.S. Other
products included Tobradex (antibiotic/steroid opthalmic for individuals having
laser eye surgery); Claritin and Allegra (allergies) purchased over-the-counter
(OTC) in Canada; Sibelium capsules (calcium channel blocker); and a variety of
OTC products sold in Canada and not available in the U.S.
Southwest Border Survey (April 2001)
On April 11, 2001, FDA, Customs, and other
agencies conducted a survey of prescription drugs being brought into the U.S. at
seven ports of entry along the U.S./Mexican border.
This survey coincided with both Easter vacations
from many colleges and the end of the "snowbird" season, when tourists
from Northern states visiting along the Southern border return home.
During the four hour "blitz" a total of
586 persons brought in a total of 1,120 drugs. Approximately 56 percent had a
prescription for the medicines (61 percent were U.S. prescriptions, 39 percent
were Mexican). The most common drugs purchased in Mexico were: Amoxicillin
(antibiotic), Premarin (estrogen), Claritine (allergy), Terramicinia
(antibiotic), Ampicillin (antibiotic), Ibuprofen (analgesic), Penicillin
(antibiotic), Vioxx (inflammation), Tafil (anxiety), Dolo Neuorobian (vitamin
supplement), Glucophage (diabetes), Celebrex (arthritis), Naproxen (analgesic),
Retin-A (acne), Ventolin (pulmonary disease), and Valium (controlled
substance/nervous system depressant).
Controlled Substances
Although we do not know, nor is it possible to
clearly determine, the amount of controlled substances brought into the U.S.
purportedly for personal use, it is likely that such medicines are frequently
imported for resale and pose a public health risk. The Agency has been working
with both Customs and DEA to streamline and clarify Federal import policies
specifically related to the importation of controlled substances.
Counterfeit Bulk Drugs
As we stated in testimony before this Committee
last year, FDA believes that the authenticity and quality of drugs dispensed in
the U.S. remains high. We do take very seriously, however, any allegation
regarding the possible counterfeiting or adulteration of imported bulk drugs,
also referred to as active pharmaceutical ingredients (APIs). The Agency agrees
that more should be done to help ensure that imported bulk drugs (APIs) and
finished drug products meet the requirements of the FD&C Act. We are
actively pursuing a number of initiatives to better detect and prevent the
importation of counterfeit or adulterated APIs.
Let me provide the Committee with a brief update
on the five initiatives that we announced at the hearings last year.
In February 2000, additional funds were allocated
to the Forensic Chemistry
Center (FCC) by the Office of Regulatory Affairs
(ORA) for sampling, analytical work and assessments of APIs gathered through
targeted inspections of importers.
During FY 2000, the FCC conducted 20 targeted
inspections, including nine at importers of foreign APIs, ten at domestic
finished dosage manufacturers and one at a domestic animal drug manufacturer.
The FCC collected more than 1,000 samples of 130 APIs and related documents and
records during the inspections. Samples of two drug substances have
been analyzed.
The information and results of analysis obtained
during the investigations indicate a need for follow-up at two foreign API
manufacturers. Provisions are being made to have ORA laboratories in New York
and San Juan assist in the analytical evaluation, and some training has already
been provided.
Make the FCC API database available
electronically to all field inspectors by
January 2001.
Direct electronic access to the FCC’s API
database was made available to all District offices beginning in January 2001.
Enhancements to the system’ s capabilities and training for the user community
are ongoing and we expect to complete these efforts by the end of the current
FY. Information continues to be added to the API database, which currently
contains 566 label images and other packaging information for foreign APIs. This
database is one important tool that FDA can use to more quickly identify whether
or not a product is authentic or counterfeit.
Expand the Philadelphia pilot nationwide by the
end of 2000.
A pilot program was begun in the Philadelphia
District office in 1997, to provide import inspectors with access to information
on the approval status of drug applications, as contained in the Establishment
Evaluation System (EES) database maintained by CDER. Access to this data allows
inspectors to obtain relevant approval information in about three to four
minutes on any API entry, which increases the probability of confirming that the
API being offered for import is from a proper foreign source manufacturer and is
intended for use by an appropriate end-user.
The program has now been expanded to all of our
districts. In December 2000, ORA provided training to field import personnel
nationwide on the use of the EES database. Since then, District Offices have
been actively using EES to insure that imported APIs are, when required, shipped
from a firm identified as an approved source in the finished dosage manufacturer’s
new drug application (NDA). FDA’s inspectors report that access to EES
information has been very useful in helping to assure that the declared source
and destinations of imported APIs are appropriate.
The Operational and Administrative System for
Import Support (OASIS) records indicate that 12 API entries have been refused
admission since January 1, 2001, based upon the appearance that the API was
misbranded because it was not from an approved source for use in the manufacture
of a finished dosage drug requiring an NDA. OASIS records indicate that under
the guidance relating to the use of EES for evaluation of API entries, FDA has
detained 499 distinct entry lines of imported APIs among 437 API entries since
January 1, 2001. However, all but the 12 refused shipments were resolved when
Districts received evidence that the API was intended for a use other than an
application finished dosage manufacturing process or was manufactured by an
approved source. Consequently, the vast majority of these entries were released
into commerce after FDA review.
Put all importers and customs house brokers on
notice that they are required to provide the name of the foreign manufacturer
upon entry into the U.S., and that the entry of their products into the U.S.
will be contingent upon it.
Last year, the Agency placed the import and
customs broker industries on notice regarding the existing requirement to
provide FDA with accurate data regarding the identity and location of the
manufacturer of imported drugs. Although these requirements were previously
communicated to importers and brokers on a number of occasions, we were not
satisfied with the level of compliance with this requirement. On July 20, 2000,
the Agency posted an updated version of this requirement on the Internet with
links to and from FDA's import operations pages. On July 28, 2000, a Customs
Automated Broker Interface (ABI) system administrative message regarding this
requirement was issued to all brokers.
Compliance with this requirement is routinely
assessed as the Agency carries out filer evaluations and is one of the factors
considered in providing continued electronic filing privileges on OASIS. Customs
has informed FDA that these types of reporting failures may be the basis for
Customs civil actions. Since January 2001, FDA has initiated four separate cases
with Customs requesting broker penalties against brokers who have failed to
provide adequate or accurate data to FDA when they filed entries. In three of
these cases, Customs has approved the requests, while a fourth case is pending.
Since June 1, 2000, 12 filers have been removed from paperless status and are
required to submit paper entry documents due to their failure to electronically
transmit accurate data for a variety of FDA products.
Require domestic manufacturers to provide
information to FDA when they
discover that the bulk materials they receive are
substandard, ineffective, or appear not to be from the approved source.
FDA is concluding the process of drafting a
proposed regulation to require such reports, which would apply to both domestic
and foreign manufacturers. We appreciated the Committee's suggestion to initiate
this requirement.
Let me now provide you with a brief update on
some other initiatives.
API Quality Sampling and Analytical Surveys
ORA and CDER are planning to perform a sampling
survey in FY 2002 targeting imported APIs for quality and, where indicated,
authenticity evaluation. This survey, which is now being designed by CDER and
ORA, will broadly evaluate the quality of foreign manufactured APIs, and
specifically target APIs that are potentially substandard or counterfeit.
Information Technology (IT) Assessment and
Enhancement
We know that one of the issues of great concern
to the Committee is the Agency's lack of a well-integrated IT system for the
regulation of drug imports. FDA currently relies on several independently
developed databases of critical information that need to be integrated.
Last July, FDA engaged the services of a private
contractor to assess the Agency's IT needs for import operations and to
recommend changes to provide field staff with ready access to the information
necessary for making informed admissibility decisions. ORA has already
implemented several IT enhancements. First, electronic access to Agency data
sources are being provided to all FDA resident posts, either by wide area
network (WAN) or by satellite technology. Second, ORA is initiating the
establishment of an enterprise portal system, which will provide a common user
interface to all of FDA’s information databases. The statement of work
containing the technical requirements for this project has been drafted and the
Agency hopes to award a contract for system design by July 2001. Through these
initiatives, FDA plans to provide more information to its field inspectors and
investigators on a much more consistent basis through a single information
access point.
Joint FDA-Customs Pilot Targeting Broker
Misdeclarations
FDA is currently piloting a joint operation with
Customs in one U.S. port to specifically target FDA filers that have
demonstrated a pattern of inaccurately declaring information material to FDA’s
admissibility decisions (whether in drug entries or other regulated
commodities). Available remedies against repeat offenders include a possible FDA
request that Customs demand physical redelivery of the shipments entered using
inaccurate information, and an initiation of broker penalties, which may be
substantial. FDA has seen recent success in initiating civil broker penalties
when filers fail to provide correct data for FDA’s evaluation upon entry. Much
of this success is a direct result of cross training of FDA’s import
operations field and headquarters personnel in Customs law and regulations and
civil remedies that are currently available to FDA when an importer or broker
fails to adhere to declaration or FDA examination requirements.
INTERNET DRUG SALES
Based on surveys conducted in early 2000 by
Office of Criminal Investigations (OCI) and subsequently by the General
Accounting Office (GAO), it appears that there are roughly 300 to 400 Internet
sites selling prescription drugs, with approximately half located domestically
and half located outside the U.S. FDA has long taken the position that consumers
are exposed to a number of risks when they purchase drugs from Internet sites or
other mail order outlets that dispense foreign drugs. These outlets may dispense
expired, subpotent, contaminated or counterfeit product, the wrong product, a
contraindicated product, an incorrect dose, or medication unaccompanied by
adequate directions for use. FDA cannot provide consumers with any assurance
that these products were manufactured under current good manufacturing practice
standards. Taking an unsafe or inappropriate medication puts consumers at risk
for dangerous drug interactions and other serious health consequences.
Internet sites that provide prescription drugs by
having consumers fill out a questionnaire rather than seeing a doctor pose
serious health risks. A questionnaire generally does not provide sufficient
information for a healthcare professional to determine if that drug is
appropriate or safe to use, if another treatment is more appropriate, or if the
consumer has an underlying medical condition where using that drug may be
harmful.
FDA has undertaken widespread public relations
efforts to warn consumers about the dangers of buying drugs online, and we have
provided extensive information on these dangers on FDA’s own Internet site.
FDA’s Buying Medical Products Online web page is one of the most frequently
requested pages on FDA’s website. It consistently ranks among the top twenty
requested pages, averaging almost 13,000 hits per month.
Currently, FDA has 90 sites under active review
for possible regulatory or civil action.
Warning letters have been sent to 48 domestic
online sellers. Additionally, FDA has sent 121 "cyber letters" to
operators of Internet sites offering to sell online prescription drugs or
unapproved drugs. These sites may be engaged in illegal activity such as
offering to sell prescription drugs to U.S. citizens without valid (or in some
cases without any) prescriptions. Cyber letters are sent over the Internet to
the suspect websites to warn the operators that they may be engaged in illegal
activities, and inform them of the laws that govern prescription drug sales in
the U.S. While cyber letters may not be the most effective enforcement tool,
they certainly have a deterrent effect and FDA has seen positive results from
using them. FDA has received positive responses from twenty percent of the cyber
letter recipients and
we are continuing to monitor these sites.
FDA also sends copies of its cyber letters to the
home governments of targeted websites, when the locations can be identified.
Follow-up depends on the ability and willingness of the foreign regulatory
bodies to investigate and take actions against website operators who are
illegally shipping drugs to other countries.
In cooperation with the Department of Justice
(DOJ), five preliminary injunctions have been imposed on the sale of a illegal
products, including one product marketed as a weight-loss aid containing a
potent thyroid hormone which could cause heart attacks or strokes, and an
unapproved cancer therapy. FDA and DOJ also are pursuing an injunction against
the sale of another unapproved cancer therapy over the Internet. Additionally,
15 product seizures, 11 product recalls, and the voluntary destruction of 18
violative products have been achieved, generally pertaining to unapproved new
drug products including gamma hydroxybutyric acid, gamma butyrolactone , Triax,
1,4 butanediol, and laetrile. Thirty-six foreign shippers have been placed on
Detention Without Physical Examination and added to Import Alert 66-57 for
targeting sales of unapproved new drug products to the U.S.
During FY 2001, FDA’s OCI initiated
approximately 40 Internet-related investigations and will continue to conduct
investigations involving suspected criminal activity related to Internet drug
sales as well as other Internet-facilitated criminal violations of the FD&C
Act. Of the 133 currently open Internet-related investigations, 64 are Internet
pharmacy cases, where the focus is on the possible dispensing of prescription
drugs without a prescription.
In recent years, OCI has initiated 285 Internet
investigations and each of these investigations have involved a variable number
of actual websites – typically ranging from one to 25 or more. OCI has
effected 88 Internet-related arrests, 70 of these in drug-related
investigations. Of the 70 drug-related arrests, 11 have involved Internet
pharmacy cases. These arrests have resulted, thus far, in 48 Internet-related
convictions, 42 of these in drug-related investigations. Of the 42 drug-related
convictions, five have involved cases involving the sale of prescription drugs
without a valid prescription.
In addition, OCI has an ongoing initiative at the
Dulles International Airport Mail Facility that had its genesis in their first
Internet case, which began in 1994. The case, which involved a site selling
steroids over the Internet, resulted in a successful prosecution and shutdown of
the website. The partnership resulting from this case has continued, and in the
past 18 months, OCI has been involved with local law enforcement in the
Washington metropolitan area in 98 drug seizures. The seizures represent dozens
of types of drugs coming in from 13 different countries. Of the 98 seizures, 87
of the drug seizures were ordered over the Internet and mailed to U.S. citizens;
six were mailed to the U.S. by family or friends living abroad; four were
ordered via a 1-800 telephone number from Canada and mailed to the U.S.; and one
was transported via an airline passenger in two suitcases from Romania. The
efforts of OCI, Customs, and local law enforcement have yielded the execution of
eight search and seizure warrants and led to the arrest and prosecution of nine
people.
CONCLUSION
Mr. Chairman, FDA remains concerned about any
possibility that counterfeit or otherwise unsafe drugs may find their way into
the American drug supply. We will remain vigilant as we refine and improve the
programs and procedures that we use to ensure the availability of safe
medications for consumers.
We appreciate the continued interest of the
Committee in these important issues, and look forward to continuing to work with
you. Thank you again for the opportunity to participate in today’s hearing. I
will be happy to answer any questions.
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