Snowe Praises Ama Passage Of New Policy In Support Of Drug Importation

Press Release

U.S. Senator Olympia J. Snowe (R-Maine), lead Republican sponsor of the "Pharmaceutical Market Access and Drug Safety Act" (S. 2328), the only bipartisan drug importation legislation in the Senate, praised today's vote by the American Medical Association at their semi-annual policymaking meeting to support the importation of prescription drugs by wholesalers and pharmacies, if certain conditions are met to ensure patient safety.

"Today, with the nation's largest physician group's support, we have moved beyond the question of 'if' to a question of 'when' drug importation will become a reality. Our bipartisan bill, with the support of essential nationwide groups, including the AARP, meets the standard of safety set by the AMA to provide the American people with a real opportunity to access to lower cost prescription drugs."

The AMA released the following qualifications as conditions of their support of drug importation:

* All drug products are Food and Drug Administration (FDA)-approved and meet all other FDA regulatory requirements;
* The drug distribution chain is "closed," and all drug products are subject to reliable, track and trace technology; and

* Congress grants necessary additional authority and resources to the FDA to ensure the authenticity and integrity of imported prescription drugs.
"I agree with the AMA that the safety of our citizens is absolutely paramount. Our primary mission in drafting the Pharmaceutical Market Access and Drug Safety Act was to have safe, effective drug importation legislation that will reduce the burden of skyrocketing drug costs on the American people," said Snowe. "I believe our bill meets the AMA's criteria and pledge to work with them during the upcoming Congress as we continue to move forward to make drug importation a reality."

Snowe specifically highlighted the safety provisions of her bipartisan drug importation bill: "We begin by importing only FDA-approved drugs. But we must do much more. We import only from those countries with comparable levels of regulation and oversight. Next we scrutinize the pharmacies and wholesalers who wish to participate. We will not simply register, but will proactively inspect every one, every three weeks, instead of waiting for 'patterns of violations' to occur - we seek to prevent them."

"Safety must be assured through the use of systems and technology which we know will help. Our bill provides that drugs will have pedigrees, they will be tracked, and anti-counterfeiting and anti-tampering technologies will be used," said Snowe.

This legislation takes dramatic steps to ensure the overall safety and integrity of the imported drugs by requiring a chain of custody or a "pedigree" be maintained and inspected. Wholesalers handling imported drugs will have to meet high standards - including detailed record keeping, labeling, and tracking requirements. The FDA will inspect pharmacies and wholesalers frequently and without warning, at least every three weeks. This is a vast improvement over our regulation of domestic wholesalers today.

This bill also combats counterfeiting by employing technologies like the one now used on the new $20 bill. Moreover, this legislation not only allows the FDA to use this existing technology, but allows for new anti-counterfeiting and track-and-trace technology in the future - such as using embedded microchips in drug packaging.

Snowe's legislation also ensures that the FDA will have the necessary resources to register, inspect and monitor wholesalers and pharmacies by charging a one percent fee on imported drugs.

"We must also ensure that trade can take place. Pharmacists and wholesalers cannot participate in importation if a manufacturer may penalize them through discriminatory practices as we see in Canada as pharmacies are cut off from products because they sold drugs to Americans. So this legislation prohibits this behavior. And if manufacturers can "game" the system by making a trivial change in the foreign product, there will be no products to import," said Snowe. "This legislation also addresses such actions."

"The Pharmaceutical Market Access and Drug Safety Act" has been endorsed by over 50 groups nationwide, including the AARP and Families USA among others. Last Spring, the legislation was called safe and effective by Dr. David Kessler, the former Commissioner of the FDA from November 1990 until March 1997. He was appointed by President Bush and reappointed by President Clinton.

"The Pharmaceutical Market Access and Drug Safety Act" has a total of 32 bipartisan cosponsors.

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