[Ip-health] Institute for Policy Innovation on Dorgan's reimportation bill

[Mike Palmedo]

6/14/2004 12:27:00 PM

To: National Desk, Legal Reporter

Contact: Sonia Hoffman of the Institute for Policy Innovation,
202-213-0379 or shoffman@ipi.org; Web: http://www.ipi.org

WASHINGTON, June 14 /U.S. Newswire/ -- Sen. Byron Dorgan (D- N.D.) has
introduced "The Pharmaceutical Market Access and Drug Safety Act of
2004" (S. 2328).

"The legislation should be referred to as the 'Get Your Drugs from Who
Knows Where Act,' because no one -- not the FDA, not the pharmacists,
not the doctors, not Sen. Dorgan and certainly not the patients -- will
know where the imported drugs really come from," says Dr. Merrill
Matthews, resident scholar at the Institute for Policy Innovation (IPI).

Before the Senate takes up this legislation, the media should ask the
senator some tough questions -- and expect some honest answers.

1. Does Sen. Dorgan know that counterfeiting of prescription drugs is a
booming industry outside the U.S., and that people routinely die in
other countries because of counterfeits?

2. Is the senator aware that the Pharmacy Society of Wisconsin recently
discovered that three Canadian pharmacies listed on the state's website
sent state residents generics not approved by the FDA instead of the
brand name drugs designated in their prescriptions?

3. Does the senator know that virtually all foreign Internet pharmacies
require customers to agree to a disclaimer intended to absolve the
company of liability should the drugs prove to be counterfeit, diluted
or mishandled? Does the senator realize, by contrast, that U.S.
pharmacies do not ask patients to agree to such documents and give up
their right to sue?

4. Has the senator listened to the FDA, which asserts that once
prescription drugs leave this country there is NO WAY for it monitor
those drugs to ensure that, if they are shipped back to the U.S., they
haven't been mishandled? Does the senator understand that U.S. agencies
like the FDA cannot force sovereign countries to adopt our standards for
drug production, maintenance and transport?

5. Since there is no way to accurately determine if drugs have been
properly manufactured and stored -- including refrigeration for drugs
such as insulin -- then is Sen. Dorgan willing to exempt the
pharmaceutical industry from liability should a reimported drug harm a
patient?

If Congress passes legislation legalizing importation from Canada and
other countries, it will open up a serious threat to Americans' health.
Anyone who thinks any differently simply hasn't listened to the FDA,
most pharmacists or the American Medical Association -- that is, the
experts who know something about medicine.

Which brings us to the final question: If patients are harmed as a
result of Sen. Dorgan's misguided legislation, will he stand up before
the American people and accept responsibility for pushing through his
bill against the strong objections of the vast majority of health care
providers?