![](media/image1.png){width="7.620833333333334in"
height="1.7284722222222222in"}

For Immediate Release CONTACT: Barry E. Piatt

Wednesday or Sanjay Talwani

April 21, 2004 PHONE: 202-224-2551

**[FACT SHEET]{.underline}**

**PHARMACUTICAL MARKET ACCESS**

**AND DRUG SAFETY ACT**

**I. Importable Drugs:**

-   Drugs must be approved by the Food and Drug Administration and
    manufactured in an FDA-inspected plant.

-   Drugs must be patient-administered and not a controlled substance,
    an infused or injected drug, a biologic, or a drug inhaled during
    surgery.

> **II. Commercial importation by pharmacists and drug wholesalers:**

-   Allows importation by licensed pharmacists and wholesalers from
    Canada within 90 days of enactment and from the current European
    Union members, Australia, New Zealand, Japan, and Switzerland
    beginning one year from enactment.

-   *Requires registration of wholesalers and pharmacies with FDA*, and
    levies capped fees to support the costs of the program. Registration
    may only be of those entities that are fully licensed in accordance
    with applicable state and federal law to act as pharmacies or
    wholesalers of prescription drugs.

-   Importers and all resellers of imported products must provide a
    *full chain-of-custody (pedigree)*, tracking possession of drugs
    from the point of manufacture to the sale to the consumer.

\-- more \--

Page -2-

-   *Drugs must be re-labeled* in English to comply with FDA
    requirements. The FDA will provide approved labeling information to
    importers.

-   FDA may ban the importation of a product that has been determined to
    be counterfeit, contaminated, or is otherwise adulterated so as not
    to meet the requirements of this legislation. FDA may require
    testing of shipments of product or use of approved
    anti-counterfeiting technologies to verify the chain-of-custody of a
    drug.

-   This bill specifically protects pharmacies, wholesalers, and
    individuals from patent damages arising from the importation of
    drugs.

**III. Personal importation by individuals:**

-   Immediately upon enactment, an individual may import up to a 90 day
    supply of a prescription drug from Canada for their personal use or
    for the personal use of a family member. Once the FDA has
    implemented regulations, individuals may be shipped purchased drugs
    directly only from a Canadian pharmacy registered under this Act,
    which must be fully inspected and approved by the FDA. Canadian
    pharmacies must validate a U.S. prescription, review health and
    medication history, and track shipments.

-   The bill also allows individual Americans who travel outside the
    United States to bring back with them for their personal use a
    90-day supply of medicine from Australia, current countries in the
    European Union, Japan, New Zealand, or Switzerland or a 14-day
    supply of medicine from another foreign country.

-   The bill continues the FDA=s current Acompassionate use@ policy of
    allowing importation for patients with special needs.

**IV. AGaming@ the system:**

-   The bill protects those selling or using drugs imported under the
    program by preventing an individual from taking actions that would
    have the effect of thwarting drug importation. Any individual who
    takes such an action against a pharmacist, wholesaler, or consumer
    to hinder their importation of prescription drugs will be in
    violation of the Clayton Act, and treble economic damages may be
    awarded.

> \-- more \--
>
> Page -3-

-   The proposal includes features to prevent a drug manufacturer from
    blocking importation of drugs, such as by changing the color, dosage
    form, or place of manufacture of the drug so that it is no longer
    FDA-approved. Drug manufacturers that make these kinds of changes
    would be required to notify the FDA, and the FDA would be given the
    authority to take the steps needed to approve the drug.

**V. Limiting unsafe drug imports:**

-   Customs could seize and destroy small quantities of drugs imported
    by individuals from foreign exporters that are unapproved. The FDA
    would provide the individual whose drugs were seized with a simple
    notice explaining how the individual can import drugs from
    registered Canadian exporters safely and legally.

\-- END \--

-   The bill also allows individual Americans who travel outside the
    United States to bring back with them for their personal use a
    90-day supply of medicine from Australia, current countries in the
    European Union, Japan, New Zealand, or Switzerland or a 14-day
    supply of medicine from another foreign country.

-   The bill continues the FDA=s current Acompassionate use@ policy of
    allowing importation for patients with special needs.

**IV AGaming@ the system:**

-   The bill protects those selling or using drugs imported under the
    program by preventing an individual from taking actions that would
    have the effect of thwarting drug importation. Any individual who
    takes such an action against a pharmacist, wholesaler, or consumer
    to hinder their importation of prescription drugs will be in
    violation of the Clayton Act, and treble economic damages may be
    awarded.

-   The proposal includes features to prevent a drug manufacturer from
    blocking importation of drugs, such as by changing the color, dosage
    form, or place of manufacture of the drug so that it is no longer
    FDA-approved. Drug manufacturers that make these kinds of changes
    would be required to notify the FDA, and the FDA would be given the
    authority to take the steps needed to approve the drug.

**V. Limiting unsafe drug imports:**

-   Customs could seize and destroy small quantities of drugs imported
    by individuals from foreign exporters that are unapproved. The FDA
    would provide the individual whose drugs were seized with a simple
    notice explaining how the individual can import drugs from
    registered Canadian exporters safely and legally.