**STATEMENT OF**

**WILLIAM K. HUBBARD**

**ASSOCIATE COMMISSIONER FOR POLICY AND PLANNING**

"CANADIAN PRESCRIPTION DRUG RE-IMPORTATION: IS THERE A SAFETY ISSUE?"

**BEFORE THE**

**COMMITTEE ON GOVERNMENT REFORM**

**SUBCOMMITTEE ON HUMAN RIGHTS AND WELLNESS**

**U.S. HOUSE OF REPRESENTATIVES**

###### June 12, 2003

####  FOR RELEASE ONLY UPON DELIVERY

**INTRODUCTION**

Mr. Chairman, and Members of the Subcommittee, I am William K. Hubbard,
Associate Commissioner for Policy and Planning at the U.S. Food and Drug
Administration (FDA or the Agency). I appreciate the opportunity to
testify at today's hearing on behalf of FDA. We are pleased to come
before the Subcommittee once again to discuss the safety of prescription
medicines obtained from foreign sources and to report on our actions
since your hearing on this issue on April 3, 2003. We will not repeat
information provided in our April 3, 2003, statement, but will focus on
additional activities that have occurred over the past eight weeks.

As we have previously testified, the overall quality of drug products
that consumers purchase from United States pharmacies is very high. The
public can be confident that the drugs they use are safe and effective.
In order to help maintain these high standards, FDA works diligently on
many fronts to ensure that consumers receive safe and effective drugs.
However, FDA cannot offer the same assurances to the public about the
safety of drugs they buy from foreign sources.

The issue of U.S. consumers purchasing drugs from foreign sources is a
significant concern for FDA. A growing number of Americans are obtaining
their prescription medications from foreign locations. They often seek
out Canadian suppliers, or sources that purport to be Canadian. As we
have said in the past, FDA cannot ensure the safety of drugs purchased
from foreign sources.

**SAFETY CONCERNS**

For public health reasons, FDA remains concerned about the importation
of prescription drugs into the U.S. In our experience, many drugs
obtained from foreign sources that either purport to be or appear to be
the same as U.S.-approved prescription drugs are, in fact, of unknown
quality. FDA cannot assure the American public that drugs imported from
foreign countries are the same as products approved by FDA.

FDA has long taken the position that consumers are exposed to a number
of risks when they purchase drugs from foreign sources or from sources
that are not operated by pharmacies licensed under state pharmacy law.
These outlets may dispense expired, subpotent, contaminated or
counterfeit product, the wrong or a contraindicated product, an
incorrect dose, or medication unaccompanied by adequate directions for
use. The labeling of the drug may not be in English and therefore
important information regarding dosage and side effects may not be
available to the consumer. The drugs may not have been packaged and
stored under appropriate conditions to avoid degradation. There is no
assurance that these products were manufactured under current good
manufacturing practice (cGMP) standards. When consumers take such unsafe
or inappropriate medications, they face risks of dangerous drug
interactions and other serious health consequences.

Over the last twelve to eighteen months, FDA identified a proliferation
of websites that sell drugs purportedly from Canada directly to U.S.
consumers. A number of these websites claim it is legal for Canadian
pharmacies to sell drugs to U.S. consumers. This is false. Some websites
are merely ordering services, taking orders from consumers that are then
filled by other pharmacies. In some cases, American consumers cannot be
certain that the drugs they receive are actually dispensed by the person
from whom they are ordered.

A number of Canadian drug websites and ordering services indicate that
the Canadian drugs are dispensed pursuant to existing prescriptions that
are rewritten by a Canadian doctor in order to comply with Canadian law.
However, dispensing medication based on a prescription written by a
physician who has not seen the patient or conducted a physical exam is
contrary to medical practice standards. In addition, the Canadian
Medical Association has stated that under the Canadian Code of Ethics,
physicians have a responsibility to do a patient history, conduct a
physical exam and discuss the risks and benefits of the medication with
the patient. In many cases, these activities simply do not occur.

Consumers who buy prescription drugs from foreign countries are at risk
of suffering adverse events, some of which can be life threatening.
These risks include potential side effects from inappropriately
prescribed medications, dangerous drug interactions or side effects due
to drug contamination. Patients are also at risk because there is no
certainty about what they are getting when they purchase some of these
drugs. Although some patients may receive genuine product, others may
unknowingly buy counterfeit copies that contain inert ingredients,
legitimate drugs that are outdated and have been diverted to
illegitimate resellers, or dangerous sub-potent or super-potent products
that were improperly manufactured. Moreover, consumers who are
desperately seeking a cure for a serious medical problem may be more
willing to accept a product of unknown origin.

In the case of foreign-based sources, if a consumer has an adverse drug
reaction or any other problem, they have little or no recourse either
because the physical location or operator of the pharmacy often is not
known or the seller is beyond the consumer's reach. In addition, as a
condition of doing business, many of these foreign operators require the
U.S. consumer to sign a document releasing the operator from all
potential liability. FDA has little or no ability to take effective
action against these foreign operators to assist U.S. consumers.

In addition to these safety concerns, it is also important to point out
that it is illegal, under the Federal Food, Drug, and Cosmetic (FD&C)
Act, to import unapproved, misbranded, and adulterated drugs into the
U.S. This includes foreign versions of U.S.-approved medications. It is
also illegal for anyone other than the drug's manufacturer to re-import
a prescription drug that was originally manufactured in the U.S.

**UPDATE ON FDA ACTIVITIES AND NEW ACTIONS**

At the April 3, 2003, hearing, we discussed our efforts to address the
potential safety concerns of illegally imported prescription medicines
by: 1) increasing consumer awareness of the potential risks associated
with imported drugs, 2) working with the states to crack down on
Internet pharmacies selling illegal products, and 3) analyzing the
quality of drugs coming into the U.S. from foreign sources.

I would like to provide you with an update on our activities and some
ongoing activities that were mentioned when we last testified before
this subcommittee nine weeks ago.

**1. Rx Depot**

At the April hearing we told you about a warning letter that was issued
on March 21, 2003, to a storefront operation known as Rx Depot. We
commenced this action in conjunction with the Arkansas State Board of
Pharmacy. Rx Depot generally obtains unapproved drugs from Canada for
U.S. consumers, exposing the public to the significant potential risks
associated with unregulated imported prescription medications. Rx Deport
and similar companies have often stated incorrectly to consumers that
FDA condones their activities and even that their prescription
medications are "FDA approved." This could lead consumers to conclude
mistakenly that the prescription drugs sold by the companies have the
same assurance of safety as drugs actually regulated by FDA.

FDA believes that operations such as Rx Depot expose the public to
significant potential risks associated with unregulated imported
prescription medicines. FDA's "warning letter" notified the firm that
the Agency considers the firm's operations to be a risk to the public
health, and in clear violation of the drug safety laws that protect
Americans from unsafe drugs. Although FDA addressed its "warning letter"
to the Rx Depot in Arkansas, FDA also sent a letter to the President of
Rx Depot, in Tulsa, Oklahoma. The "warning letter" applies to all
locations of Rx Depot and its affiliates. While Rx Depot responded to
FDA's "warning letter," that response was inadequate.

We issued our "warning letter" in conjunction with action by the
Arkansas State Board of Pharmacy. The Arkansas State Board of Pharmacy
issued its own letter to the firm on the same day as our "warning
letter" instructing the firm to cease violating state law immediately.

**2. Additional Information on Counterfeit Drugs**

On [April 22, 2003,]{.underline} the Pharmaceutical Research and
Manufacturers of America (PhRMA) announced the adoption of a voluntary
program to report counterfeit drugs to FDA. PhRMA represents the
country's leading research-based pharmaceutical and biotechnology
companies. The announcement affirmed that the information provided by
PhRMA members under this program will assist FDA in carrying out its
responsibilities to protect the safety and integrity of the nation's
drug supply by quickly and effectively removing counterfeit drugs from
the marketplace.

Under the voluntary program, PhRMA member companies agree to notify
FDA's Office of Criminal Investigations within five working days of
determining that there is a reasonable basis to believe that a product
has been counterfeited. The program also applies to counterfeits
discovered in foreign countries if there is clear evidence that the
counterfeits are intended for distribution in the U.S. The reporting
program went into effect on May 1, 2003.

In an [April 22, 2003,]{.underline} press release, FDA praised PhRMA's
commitment to actively help FDA identify and remove counterfeit drugs
from the U.S. market. "This action adds to our tools for protecting the
public against counterfeit drugs," said FDA Commissioner, Mark B.
McClellan, M.D., Ph.D. "The FDA works with local, state, and Federal law
enforcement authorities to protect Americans from the health risks of
bogus drugs. PhRMA's members already assist in these efforts by actively
investigating credible reports about the distribution of counterfeit
drugs. This formal collaborative agreement will strengthen the FDA's
ability to assure the safety and effectiveness of drugs used by
Americans."

FDA supports the activities of the manufacturers of legitimate drugs to
identify counterfeit products and inform the public about counterfeits.
The Agency is committed to rooting out counterfeiting activity and
alerting the public to the existence of counterfeit product.

**3. NABP Annual Meeting**

On [May 7, 2003,]{.underline} FDA officials spoke at the National
Association of Boards of Pharmacy (NABP) Annual Meeting in Philadelphia,
Pennsylvania. FDA reiterated the message it delivered in the call it
hosted in February 2003 with 38 state boards of pharmacy, other state
regulatory agencies and consumer groups. FDA is working with states to
address concerns regarding the importation of foreign prescription
drugs. The Agency is actively engaged with a number of states in jointly
pursuing illegal Internet prescription drug sites. FDA continues to
expand its cooperative activities with states in order to effectively
address the many challenges of prescription drugs sales via the
Internet.

# 

#  4. Statement by U.S. and Canada Pharmacy Groups 

On [May 7, 2003,]{.underline} the NABP and the Canadian National
Association of Pharmacy Regulatory Authorities endorsed a statement
opposing illegal importation of prescription drugs. In the statement,
the two groups state that they are mutually committed to working
together to support the individual members of their organizations as
they fulfill their regulatory mandates. The Canadian and American
regulatory bodies are calling on law enforcement agencies to promote
compliance with Federal, state, and provincial pharmacy laws and
standards of Canada and the U.S. in their respective jurisdictions. This
is the first time that the regulatory authorities of the two nations
have jointly responded to the growing practice of importation of drugs
into the U.S. from Canada.

On [May 13, 2003,]{.underline} 44 U.S. pharmacy groups joined forces
with the Canadian Pharmacists Association (CPhA) to endorse a statement
opposing illegal importation of prescription drugs. These groups include
many of the state boards of pharmacy and academic institutions schools
of pharmacy.

# 5. Other actions with states

FDA sent a letter to the Executive Director and General Counsel of the
West Virginia Board of Pharmacy expressing support for the May 13, 2003,
"warning letter" issued to Discount Prescription Center of Fairmont,
West Virginia, telling that firm to cease violating the law. Discount
Prescription Center solicits patients and arranged for a Canadian
pharmacy to dispense and ship prescription drugs to the patients. FDA
considers the firm's operations to be illegal and a risk to public
health. FDA expressed support for the Board's effort to stop this firm
from violating the law. In addition, FDA offered assistance in any
future efforts by the Board to stop similar firms.

FDA stated in the letter that we believe that operations such as
Discount Prescription Center expose the public to the significant
potential risks associated with unregulated imported prescription
medications.

We have been working closely with our partners in the states such as
West Virginia on this issue, and we intend to continue working closely
with the states in support of our mutual efforts to protect the public
health by curtailing illegal and potentially dangerous operations.

**6. Lipitor investigation**

On [May 23, 2003,]{.underline} FDA issued an alert on counterfeit
Lipitor. The alert warned health care providers and others that three
lots of counterfeit Lipitor represent a potentially significant risk to
consumers. One in five people have high cholesterol that may lead to
cardiovascular disease, such as heart disease and stroke. According to
the American Heart Association (AHA), every 33 second, someone in the
U.S. dies due to cardiovascular disease. (Source: AHA 2002 Heart and
Stroke Statistical Update) Lipitor is the number one prescribed
cholesterol-lowering medication, and is currently used by more than 18
million people. Lipitor is proven to lower total cholesterol and
decrease the risk of developing cardiovascular disease. FDA
investigators have aggressively pursued a variety of leads all along the
supply and distribution chain in an effort to identify the source of
this counterfeit activity.

In conjunction with the manufacturer of this product, FDA published a
list of lot numbers to identify the counterfeit product. We urged health
care providers and patients alike to check the packaging very carefully
before using this product. Patients who have any of the product (labeled
as "Repackaged by MED-PRO, Inc.") with the specified lot numbers were
told not to consume it, and to return the product to their pharmacies.
On June 3, 2003, FDA announced that its continuing investigation of
counterfeit Lipitor identified additional counterfeit quantities of the
cholesterol-lowering product. The investigation is ongoing.

FDA's advice to health care providers and consumers remained the same as
when the Agency issued its original [*alert on counterfeit
Lipitor*](http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01224.html).
They should check the packaging very carefully before using Lipitor.
Patients who have any of the product with any of the lot numbers we
identified should not take it, and they should return the product to
their pharmacies. We want to reemphasize this warning today.

As part of the FDA's ongoing efforts to investigate and respond to
unscrupulous counterfeiting activities, FDA's Office of Criminal
Investigations is investigating this case of counterfeit Lipitor in
carrying out its public health mission. FDA regularly conducts
investigations and testing to identify and remove from market products
that are counterfeit, have been tampered with, or are otherwise
unsuitable.

FDA is working closely with the individual states and with health
professionals, particularly pharmacists and pharmacy associations, to
alert them to this counterfeit product. Many patients taking Lipitor do
not receive it in the 90-tablet bottles, but in smaller quantities from
their pharmacists. Patients who are not sure whether they have the
tainted product were instructed to check with their pharmacist.

FDA will continue to work closely with the manufacturer of Lipitor,
Pfizer, Inc., on this counterfeiting problem. FDA supports the
activities of legitimate manufacturers to inform the public about
counterfeit products and how to identify them. In addition the
manufacturer of Liptor, Pfizer, issued their own press release
supporting the vigorous enforcement of the law to protect patient
safety. The company continues to work closely with the FDA and other
regulatory authorities to help prevent the importation of counterfeit
medicines.

# 

# 7. CPhA public statement

On [May 31, 2003,]{.underline} the CPhA Board of Directors approved a
public statement on international prescription services. The statement
emphasizes that there is potential for the existing public protection
safety net to be bypassed by illegitimate operators or unaccredited
pharmacies, or by licensed pharmacies that do not comply with practice
standards and regulation. Such practices can undermine the drug
regulatory systems established to protect consumers and could expose the
public to improper prescribing, monitoring or dispensing of
pharmaceuticals, or to harmful or ineffective drugs.

In part, this statement criticizes international prescription services
provided to residents of foreign countries. Some of the key elements of
their public statement emphasize that:

1.  A relationship between the patient and pharmacist is essential for
    medication management and to ensure that patients understand how to
    use their medications safely and effectively.

2.  Face-to-face communication between patients and pharmacists builds a
    relationship that is critical to the optimal management of drug
    therapy and is a key element of the expanded role of pharmacists on
    the primary health care team.

3.  All pharmacies operating in Canada, including those that provide
    distance dispensing or offer prescription drug services over the
    Internet, must comply with Federal/provincial/territorial legal and
    regulatory requirements as well as meet established standards of
    practice for patient care and dispensing.

4.  CPhA opposes international prescription services where the patient
    does not have a relationship with the pharmacist and the prescriber.
    CPhA also opposes international prescription services if such
    services violate laws in the jurisdiction that the patient resides
    in.

**CONCLUSION**

FDA is working to address its continued safety concern about increased
importation of prescription drugs. However, despite continued efforts to
identify ways to assure the safety of imported drugs, FDA for many years
has consistently stated that it cannot assure the safety of prescription
drugs that are obtained outside its comprehensive regulatory system.

We appreciate the subcommittee's interest in assuring that the American
public has access to safe and affordable medicines and we look forward
to working with you in furtherance of this goal. Thank you for the
opportunity to update you on events and activities since our last
hearing. I will be happy to answer any questions you may have.