Imported drug bill overcomes Senate hurdle

Measure could derail FDA reform effort

May 04, 2007|By Ricardo Alonso-Zaldivar | Ricardo Alonso-Zaldivar,Los Angeles Times

WASHINGTON -- The Senate, giving a boost to a measure long favored by congressional Democrats, opened the door yesterday to letting American consumers save money on prescription medicines by ordering them directly from Canada and other developed countries where prices are lower.

The move could have an unintended side effect - derailing a long-awaited, bipartisan effort to improve the Food and Drug Administration's faltering system for protecting patients against potentially dangerous medications. The reform plan includes increased funding for drug safety and creation of a nationwide computer surveillance system designed to spot problems with medications approved for the market.

Proponents of allowing consumers to buy drugs from Canada and other sources are trying to attach the proposal to the FDA bill. The bill is considered must-pass legislation because it includes the new safety measures and a new user-fee agreement with the industry that is critical for the FDA's overall budget.

Senators who favor allowing drug imports - led by North Dakota Democrat Byron Dorgan - won a 63-28 procedural vote yesterday to allow full debate on their amendment.

As a result, instead of an expected vote to approve revamping the drug-safety system, the Senate put off action until next week and set off new political skirmishing.

Pharmaceutical companies - whose user fees now pay about half the cost of reviewing new drugs - are determined to stop the import bill.

The industry has powerful leverage. Before the import measure was put forward, it had agreed to support higher user fees to cover most of the cost for improving the drug-safety system. That agreement may be in jeopardy.

President Bush's advisers have threatened to recommend a veto of the FDA safety and funding bill if the import language remains. Senate Republicans have scrambled to line up support for an amendment that would effectively undo Dorgan's proposal.

The developments have put consumer groups in a quandary as they back both a stronger safety system and freer access to medications from abroad.

Opponents of Dorgan's bill say lifting import restrictions could result in an avalanche of counterfeit pills, an argument also made by the pharmaceutical companies.

Ricardo Alonso-Zaldivar writes for the Los Angeles Times.

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