House drops FDA safeguards from drug reimportation bill

Strong opposition has not fazed lawmakers hunting for ways to lower the price of drugs and Medicare reform.

By Joel B. Finkelstein, amednews staff. Aug. 18, 2003.

Washington -- House passage of new drug reimportation legislation sets the stage for a clash with the Senate over safety concerns.

Both bodies earlier this summer included reimportation language in their visions of Medicare reform. Those provisions require the Food and Drug Administration to certify the safety of reimportation, something the agency has refused to do in the past.

But the new House bill would allow reimportation without requiring the FDA to certify the process. That language now supplants the earlier reimportation provision and has become the position of House lawmakers negotiating with the Senate on a final Medicare package.

The House move came despite intense lobbying efforts from the pharmaceutical industry and opposition from some medical groups, including the American Medical Association.

"We don't want to sacrifice safety for affordability," said Donald J. Palmisano, MD, AMA president.

The Bush administration also has come out strongly against reimportation. FDA officials have done everything short of lobbying Congress members to discourage the passage of any reimportation legislation.

The House and Senate bills differ on points other than the need for FDA approval. The Senate measure would allow reimportation only from Canada. The House bill covers only FDA-approved drugs produced at FDA-approved factories. The drugs can come from the European Union, Australia, Canada, Iceland, Israel, Japan, Liechtenstein, New Zealand, Norway, Switzerland and South Africa.

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