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William K. Hubbard
Senior Associate Commissioner for Policy, Planning and Legislation
Food and Drug Administration
Subcommittee on Consumer Affairs, Foreign Commerce and Tourism
Committee on Commerce, Science and Transportation
United States Senate
September 5, 2001
Release Only Upon Delivery
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. 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. 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 websites 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
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,
fatal arrhythmia and dangerous drug interactions;
loss of white blood cells (agranulocytosis) associated with fatal infections; and
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
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.
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
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 (OTC) 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 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).
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.
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. Cyber letters have a deterrent effect and FDA has seen positive results from
using them. FDA has received positive responses from 20 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
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.
Mr. Chairman, FDA remains concerned about any possibility that 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
We appreciate the Committee interest in assuring that the American public has access to safe and
affordable medicines. We 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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Last revised: September 14, 2001