STATEMENT OF DAVID CERTNER BEFORE THE IMPORTATION TASK FORCE

CONSUMER STAKEHOLDER MEETING

**[MARCH 19, 2004]{.underline}**

Mr. Chairman and members of the task force, my name is David Certner,
and I am the Director of Federal Affairs for AARP. AARP believes the
enactment of last year's Medicare prescription drug law was a good first
step in the effort to provide access to affordable prescription drugs to
older Americans. However, more must be done to hold down the rising
costs of prescription drugs. Importation is one important element in
that effort.

The health and safety of individuals must remain paramount. But the
viability and need for safe importation must be addressed within the
context of two critical health concerns:

-   First, the health security of those who cannot afford and thus do
    not take the proper medication, and

-   Second, the large and growing number of Americans who are already
    traveling to Canada or purchasing drugs over the internet today,
    without any safety regime in place.

**[Importation Safety Issues]{.underline}**

AARP supports importation from licensed Canadian pharmacies and
wholesalers provided that certain safety features are in place.  We are
confident that drugs purchased from Canada can be as safe as drugs
purchased in the U.S. However, we also know that supply can be limited
to Canada, and thus many have proposed importation beyond Canada. Should
legislation be enacted, or regulations promulgated, that would allow for
the importation of drugs from other countries, AARP would like to see
the following safeguards enacted:

**[FDA Certification]{.underline}**

-   FDA will need the authority and resources to inspect pharmaceutical
    plants in foreign countries to ensure the plants conform to US
    safety standards. In some cases, specific plant lines of production
    can be certified in lieu of certifying the entire plant.

-   FDA should certify the safety of pharmaceuticals from these plants. 
    For example, FDA should provide electronic links from its web site
    to approved internet pharmacies in Canada. 

    -   Having the FDA web site as the point of contact for a list of
        approved pharmacies will provide consumers with an official,
        secure internet site for safe drugs.

    -   Consumers without Internet access should be able to call a toll
        free number sponsored by the FDA or HHS in order to get
        information.

    -   International pharmacies eligible to participate in importation
        activities must be fully accredited and licensed by a reputable
        licensing board.

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-   There must be mechanisms in place to guarantee the quality of
    pharmaceutical dispensing and distribution. For example:

    -   Pharmaceuticals should be dispensed and distributed according to
        the usual and customary practice of the industry.

    -   Consumer privacy should be protected.

    -   Shipping and handling, processing fees, and other costs should
        be reasonable and fully disclosed to the consumer.

**[Pedigree Requirements]{.underline}**

-   FDA will need the authority and resources to enforce pedigree
    requirements back to the point of manufacture.  Initially these
    pedigree requirements should be either in paper or electronic form,
    although eventually paper should be phased out in favor of the
    electronic form.

-   FDA will need the authority and resources to inspect the flow of
    prescription drugs from the point of manufacture to the ultimate
    destination, both in instances of reported noncompliance, as well as
    on an annual basis, as needed. 

-   Imported pharmaceuticals should be shipped in a manner that provides
    a tracking number (e.g., Federal Express, DHL, UPS, etc.) to reduce
    the opportunity for counterfeit pharmaceuticals to enter the stream
    of commerce from outside the point of manufacture.

**[Anti-tampering/anti-counterfeiting requirements]{.underline}**

-   The FDA should consider prohibiting repackaging/relabeling of
    pharmaceuticals imported from other countries. 

    -   The FDA can enforce this requirement through its pedigree
        standards.

    -   Labels for pharmaceuticals destined for the US should be written
        in English at the point of manufacture.

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-   As the technology in this area progresses imported pharmaceuticals
    should be equipped with state of the art anti-tampering and
    anti-counterfeiting devices, such as bar codes, specialized ink,
    etc. 

 

**[Other Issues]{.underline}**

In addition, there are other issues the Task Force should consider:

-   While we need to ensure the safety of imported pharmaceuticals,
    there remains a strong need to examine the safety of pharmaceuticals
    within the United States drug supply in order to prevent
    counterfeit, diluted, or ineffective drugs.

-   Pharmacies should be subject to rigorous privacy standards to ensure
    the confidentiality of individuals' personal health information. 
    U.S. privacy laws, such as HIPAA, may be unenforceable with respect
    to imported pharmaceuticals.

-   The FDA, or other U.S. entity, should assess the impact of regulated
    importation on the price and quality of pharmaceuticals worldwide.

**[Conclusion]{.underline}**

In conclusion, we urge this task force to expedite its work, so that by
mid-year we have the benefit of your efforts as legislation moves
forward this year. It is important to keep in mind that our members are
daily pressed by the high costs of prescription drugs. Many already have
chosen to go to Canada, or to purchase their drugs through the internet.
It is not simply a question of whether importation should be legal or
not. The fact is that importation is happening today, and it is critical
that we ensure that it is done under a regime that best ensures safety.
Thus we urge the task force to address issues raised in this statement,
as well as other measures to ensure safety, including such issues as:

-   What resources (human and financial) will FDA need to ensure safety?

-   Whether any imported drugs have different formulations than the US
    market?

-   How to ensure safety in plants that produce the same drug but use
    different standards based on where the drug is sold?

The American public, and our members, are demanding action on
prescription drug costs. This task force, by addressing how best to
ensure the safe importation of pharmaceuticals, has an opportunity to
address this critical health care issue. We look forward to working with
you to help Americans have greater access to affordable prescription
drugs.