**Statement of the American Pharmacists Association (APhA)**

**to the Department of Health & Human Services'**

**Drug Importation Task Force**

**May 14, 2004**

**Presented by Susan C. Winckler, RPh, Esq**

**Vice President, Policy & Communications**

**Staff Counsel**

**American Pharmacists Association**

Dr. Carmona, members of the Task Force, thank you for inviting the
American Pharmacists Association (APhA) to appear before you this
afternoon. APhA welcomes the opportunity to present the views of the
nation's pharmacists on the issue of prescription drug importation. I am
Susan C. Winckler, a pharmacist and an attorney, and Vice President,
Policy & Communications and Staff Counsel for APhA. APhA's 50,000
members include pharmacist practitioners, pharmaceutical scientists,
student pharmacists, pharmacy technicians, and others interested in
advancing the profession.

The Task Force has been charged with a significant responsibility -- to
determine if prescription drug importation can be conducted safely and
its potential impact on public health, medical costs, and the
development of new medications. To make this determination, the Task
Force has been asked to consider a number of important questions ranging
from the scope and volume of imported drugs, the adequacy of safety
protections, and potential liability issues, to the need for
modifications in manufacturing and distribution technologies, the drug
distribution system, and state and Federal laws.

It is clearly an arduous task -- these are not easy questions to answer.
It is difficult to assess the current scope and volume of prescription
drug importation into the United States. Because importation is illegal
and the products enter the country outside of our normal distribution
system, there is no method to accurately track the quantity, or the
effects of, all the medications that illegally enter the U.S. That said,
it is clear that at least "interest" in importation is increasing, and
others may present statistics on the actual prevalence of importation
activity.

We understand why the interest in importation has escalated in recent
years -- many have rallied around importation as the "solution" to
providing consumers access to lower cost prescription drugs. As
pharmacists, we are concerned that some patients -- especially seniors
-- face challenges in accessing valuable, but sometimes unaffordable,
medications. Any pharmacist who has ever worked in a community pharmacy
can vividly recall the dismay of having to tell a patient -- especially
a senior on a fixed income -- the cost of their medication, knowing that
the cost may be more than the patient can afford. The Association and
our pharmacist members strongly support efforts to enhance patient
access to prescription medications. However, we have significant
concerns with proposals to "solve" the problem by expanding importation.
Our concerns generally fit in two areas: the integrity of the drug
product itself and the impact of importation on patient care.

**The Integrity of the Medication**

The current U.S. drug distribution system was not designed to facilitate
prescription drug importation. The system was designed to keep
unapproved and potentially unsafe medications from entering the U.S.
drug supply. Current U.S. laws and regulations were put in place after
several critical incidents resulted in patient harm. When patients were
harmed by contaminated or ineffective medications, Congress took action
to protect patients. Those actions included requiring evidence of safety
and effectiveness, controlling the production and distribution of
products, prohibiting the importation of unapproved medications, and
other efforts to limit the presence of counterfeit and contaminated
medications. Intentionally circumventing the U.S. regulatory system
creates an opportunity for mislabeled, mishandled, subpotent, or
counterfeit drugs to make their way into the hands of patients.

***Opening the Door to the Closed Distribution System***

The Task Force has been asked to consider how limiting importation to
specific countries will affect the ability to ensure drug safety. While
some countries, such as Canada, may have a system to regulate
medications comparable to our system, it is important to recognize that
a program to import prescription drugs from Canada -- no matter how
carefully designed -- will open the closed U.S. regulatory system to
countries beyond Canada. "Opening the door" to Canada opens the door --
period. Even if attempts are made to limit access to one country, or
even to specific pharmacies, opening the system will create incentives
for unscrupulous operators to penetrate the system. Consider, for
example, how U.S. regulatory authorities will know that one package of
prescription drugs crossing the U.S. border is "legitimate" (a
prescription filled through an "approved" importation program) versus
another package of prescription drugs entering the U.S. from an
unapproved country or pharmacy. The perils of personal importation via
the internet are many. If our closed system is opened, we must have
strong measures---and enforcement behind those measures---to help
decrease the likelihood of unscrupulous operators preying on consumers
through their medicine cabinet.

With our current system, few consumers perceive a threat from
counterfeit medications---and that perception matches reality. But even
[with]{.underline} the comprehensive U.S. system, counterfeit drugs have
penetrated our system. According to the Food and Drug Administration
(FDA), the number of counterfeit drug investigations has increased
four-fold since the late 1990s.[^1] For example, last year 11,000 boxes
of counterfeit Epogen^®^ and Procrit^®^ were found on pharmacy shelves
and in patients' homes. Three months later, the FDA discovered five lots
of counterfeit Lipitor.^®^ These examples support the need for review
and refinement of our existing safety net, not the expansion of efforts
to circumvent or relax that system. Poorly constructed importation
relaxes that system, and damages our safety net. Just three months ago,
the FDA warned of counterfeit Ortho Evra^®^ contraceptive patches that
contain no active ingredient and were being sold online by a company
based in India. By opening the door to importation, we increase the risk
the introduction of counterfeit medications into our drug supply.

Pharmaceuticals are affected by multiple factors that may not be readily
apparent to consumers. The majority of American consumers are probably
not aware that differences can exist between versions of a medication
with the same active ingredients. Medications obtained outside of the
U.S. may contain different formulations -- with differences in the
amount of active ingredient

or differences in the type of inactive ingredients-- both of which can
affect the product's stability and how the product works. Because of
these differences, any safe importation system must limit importation to
*products* approved by the Food and Drug Administration, not merely
products that contain the same, or similar, active ingredients.
Medications are different---and minor differences matter.

Storage and shipping conditions can also affect drug stability and
potency. Consumers who obtain their medications outside the U.S. have no
way to know how their medications were handled. Was the medication
maintained at the correct temperature? Was the medication stored in the
correct type of container? Was the medication properly protected during
shipment? These questions must be addressed to assure that the
FDA-approved product reaches the consumer as intended.

**Impact on Patient Care**

Importation not only weakens the U.S. system of medication regulation,
it also directly impacts patient care. While much of the importation
debate is driven by disparities in drug pricing, those disparities are
evident only on the front end---when we only know the cost of the drug,
not the value. The most expensive medication is the one that doesn't
work: in the situation where the drug doesn't lower blood pressure
appropriately, the consumer paid good money, but got no benefit. In
addition to paying cash, they paid for it with their health as their
condition went unmanaged. The value of a medication should be assessed
after the consumer has used it, after consultation with their pharmacist
and doctor to make the best use of it. But this collaboration is
challenged in many importation scenarios.

Because of the stigma involved in importing medications, many patients
do not tell their physician or pharmacist about medications they are
securing outside of the U.S. This is understandable, but dangerous.
Unless the patient provides this information, pharmacists and physicians
have no way of knowing what a patient is taking. Pharmacists' ability to
identify drug-to-drug interactions is extremely hindered, if not
completely prevented, without knowing about a patient's entire
medication regimen or the content and strength of a particular drug.

If a patient obtains medications from multiple sources -- in this case
through importation and a local pharmacy -- neither the domestic nor
international pharmacist has the patient's complete medication profile.
The pharmacist is unable to determine whether the new prescription will
conflict with any other medications the patient takes, whether the new
prescription has ingredients that duplicate a current prescription, or
whether its mere presence suggests other medical problems for the
patient that should be followed-up with the patient's physician. This
virtual blindness compromises the ability of physicians to care for
their patients and the ability of pharmacists to partner with patients
to improve medication use and advance patient care.

Problems also occur when a patient suffers unexpected complications or
does not respond as expected to a medication. Consider a patient working
with their local physician to treat their high blood pressure. The
patient imports a faulty medication that has no, or little, active
ingredient. It is unlikely the patient will physically feel anything
different; unlikely he would actually notice any difference in the
product. Later the patient visits the physician and a blood-pressure
reading shows that the medication is not working. Because of our trust
in the medication supply, it is highly unlikely that the physician will
consider that there was a problem with the medication. Rather, the
physician will likely assume that the medication did not work and will
consequently either increase the dose or choose another medication. This
sets the stage for using a stronger, but potentially unnecessary,
medication and increasing overall health care costs.

Any proposals to legalize importation must address concerns with
coordination of care. Allowing the importation of unapproved products
will exacerbate this concern; and supporting personal importation will
continue to create challenges for individual health care professionals
and their patients. All of these scenarios cloud the promise of improved
health from medications.

**The Need to Address Issues of Concern**

When you consider all of the risks associated with the importation of
prescription drugs, just a few of which I describe, it appears foolhardy
to consider haphazardly opening our borders to imported pharmaceuticals.
Allowing importation carries the risk that mislabeled, mishandled,
subpotent, or counterfeit drugs will reach the hands of our friends, our
family, our neighbors. It also disrupts the connections and improvements
we are trying to make in the health care system.

But this discussion is not just academic -- we know that unapproved and
potentially unsafe drugs enter our country [today]{.underline}. Despite
laws generally prohibiting importation by anyone other than the
manufacturer, illegally imported prescription drug products arrive in
mailboxes every day. For example, recent examinations of mail shipments
at four mail facilities by the FDA and the U.S. Customs and Border
Protection Bureau found that of 1,982 packages examined, 1,728 contained
unapproved imported pharmaceuticals.[^2] The products included so-called
"foreign versions" of FDA-approved drugs that may vary from U.S.
standards in potency and purity, improperly labeled drugs, controlled
substances, recalled drugs, drugs requiring special storage conditions,
and drugs requiring close physician monitoring. The FDA also found that
many of the drugs were manufactured outside of the U.S. in countries
such as Canada, Mexico, Costa Rica, India, Pakistan, New Zealand,
Taiwan, Thailand, and others.

Do importing consumers know about these challenges? Likely not. Do their
doctors and pharmacists? The probably know of the challenges at some
level, but they are not likely considering them in the context of their
patient population. This situation is unacceptable. If we continue to
allow importation without safeguards to assure the safety and quality of
the medications, we risk further weakening the U.S. system of medication
regulation, a system that has stood as the strongest in the world. More
importantly, consumers are risking their health.

The question the Task Force should examine is not 'do we allow
importation?' The question should be 'what do we do to assure the safety
and the integrity of the U.S. drug supply?' I see two options. One, we
begin strictly enforcing current law that prohibits importation. Provide
the FDA, the Drug Enforcement Administration, Customs Bureau, and other
regulatory agencies the funds and resources necessary to enforce the
law; and continue efforts to find other means of increasing access to
affordable medications. But this option isn't likely. As more than one
commentator has announced, there are no 'bodies in the streets'---no
documentation of a consumer being killed by importing drugs. While
enforcement of our laws may once have been an option, it doesn't seem
likely today. At a minimum, however, policymakers should avoid any
further endorsement of this unregulated and unknown practice. Rather
than endorsing this practice, we must continue to educate consumers on
the risks. The status quo must change.

If the current law does not work, we are faced with the second option:
developing a new system to assure the safety of our medication supply. A
new system, regardless of whether or not it allows importation, must
resolve several issues of concern to ensure that patients continue to
receive safe and effective medications---and that they know how to use
those medications. A new system must address the role of the FDA and the
State Boards of Pharmacy in maintaining a safe drug supply, respect the
patient-pharmacist-physician relationship, require valid prescriptions,
assure consumer recourse for harm, prevent efforts to circumvent US
health care professionals, include measures to limit counterfeit and
contaminated drugs, and address the differences between FDA-approved
medications and foreign products. Even this long litany of issues is not
an exhaustive list of what must be tackled when evaluating a system to
protect the U.S. drug supply and American consumers.

Prescription drugs, unlike so many other products, are not just another
commodity -- we ingest them to affect our bodies. They are one of the
most valuable weapons we have in our health care arsenal today and we
must treat them as such. As pharmacists, we rely on the quality of the
U.S. prescription drug supply to provide our patients with safe and
effective treatments. As the FDA does when it evaluates a new
prescription drug, we must look at both the risks and the benefits and
determine if the benefits outweigh the risks. Importation may provide
the benefit of lower cost prescription drugs, but as currently practiced
it appears that the benefits do not outweigh the potential risks. We
caution the Task Force against recommending importation as an
alternative method of drug distribution without appropriate
safeguards---both in statute or regulation [and]{.underline} in
enforcement. At a minimum, any legalization of importation should be
limited to drug products approved by the Food and Drug Administration
and assure coordination of care with the consumer's doctor and
pharmacist.

In conclusion, thank you for the opportunity to provide comments on this
important issue. APhA appreciates the Task Force's commitment to fairly
and comprehensively examine the wide range of issues surrounding the
prescription drug importation debate. We offer our assistance to the
Task Force as you continue your valuable work. Thank you.

[^1]: William Hubbard. Statement before the Senate Committee on Finance
    Subcommittee on Health Care and

    Subcommittee on International Trade. April 27, 2004.

[^2]: Food and Drug Administration. Press Release: Recent FDA/U.S.
    Customs Import Blitz Exams Continue to Reveal

    Potentially Dangerous Illegally Imported Drugs. January 27, 2004.