House Passes Bill To Overhaul Drug Safety After Vioxx Debacle

Wednesday, September 19th 2007, 9:59 pm

By: News On 6

WASHINGTON (AP) _ The Food and Drug Administration would gain new authority to ensure the safety of prescription drugs, including the power to mandate label changes that warn of newly emerging risks, under a bill passed Wednesday by the House.

The bill, heralded as the most significant drug safety legislation in more than 40 years, passed on a 405-7 vote. The Senate was expected to pass the bill as early as Thursday. President Bush is anticipated to sign it into law.

The House vote came after months of negotiations to resolve differences between the two versions of the bill, previously passed with broad bipartisan support by the House and Senate.

Broadly, the bill renews for five years two programs to collect fees from drug and medical device manufacturers to defray the FDA's expense in reviewing products seeking agency approval. The FDA has warned if the fees programs are not renewed by Friday, it will be forced to begin sending layoff notices to nearly 2,000 of its employees. That now appears unlikely.

In the wake of the Vioxx withdrawal and subsequent problems with other drugs, lawmakers seized on the legislation to overhaul how the FDA handles the safety of the drugs it regulates. The bill also seeks to increase the agency's scrutiny of drugs after they are on the market. As was the case with Vioxx, serious safety concerns took years to emerge.

The bill would require companies to publicly release results of all clinical trials that show how well their drugs performed, although the level of disclosure remains to be determined. It also would give the FDA the power both to require drug companies to further study the safety of medicines if needed and to mandate new label warnings. Republican fears that language contained in that latter provision would expose drug companies to liability if sued in state court had helped hold up negotiations.

The FDA also would gain the ability to fine drug companies for not completing follow-up studies on their drugs after they've won government approval. While companies today often agree to do such studies, they are slow to get under way and slower to be completed, if ever.

The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in fees next year.

Stripped from the bill was a bid by Democrats to limit to three months, from the current six months, in additional patent protection blockbuster drugs can gain if their manufacturers study their use in children. The stripping of even three months of protection from generic competition could spell several hundred million dollars in lost revenue for the makers of drugs with sales that exceed $1 billion a year.