With the number of Americans using prescription drugs continuing to rise, the Food and Drug Administration got broad new power to ensure the safety of these drugs under a bill President Bush has signed into law.
The new law renews for five years programs to collect fees from drug and medical device manufacturers, defraying FDA costs of reviewing products.
Members of Congress, acting in the wake of the withdrawal of the painkiller Vioxx three years ago, seized on the legislation as a vehicle to reform the FDAs handling of drug safety. The legislation also shifts more of the agencys attention from experimental drugs pending approval to those that already are on the market.
It gives the FDA the power both to require drug companies to further study the safety of medicines if needed and to mandate new label warnings, when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities. The legislation also requires 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.
The FDA also will be able to fine drug companies for not completing follow-up studies on their drugs after theyve won government approval. Those studies frequently remain undone, often leaving important safety questions unanswered. The bill calls for drug companies to pay $393 million, and medical-device makers $48 million, in various fees next year. -- by the Associated Press
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