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Congress poised to give more power to the FDA
The U.S. House of Representatives has approved a bill designed to give the FDA more money and more authority to monitor and enforce drug safety rules. The bill, which is expected to pass the Senate this week, has pulled off the rare trick of winning over both consumer and industry groups. Not only did the president of the Consumers Union praise the measure, pharmas generally support it, too, according to the Pharmaceutical Research and Manufacturers of America. While its main immediate impact will be to reauthorize funding for the agency, it's far more than a standard reauthorization measure, observers say.
Among other things, the comprehensive bill includes a provision that will kick up fees to pharmas and drug makers which should generate an additional $400 million for the agency. The measure would also require drug makers to publicly post the results of any clinical trials involving approved medicine, and allow the agency to force drug makers to conduct new clinical trials for already-approved medications.
To get more details on the measure:
- read this article in The New York Times
Related Articles:
Researcher challenges FDA approval process. Report
Bill giving FDA more drug safety powers could pass. Report
FDA emphasizing speed over safety? Report
FDA boosts reviews for new drugs. Report
Report faults FDA's post-marketing vigilance. Report
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