Bill to Give FDA Broad New Powers

On Sept. 19, the House passed legislation that would give FDA broad new powers to monitor prescription drugs and medical devices. The bill, H.R. 3580, would increase prescription-drug user fees—the fees manufacturers pay FDA for review of their drugs-from $305 million to $392 million collected annually and devote a larger portion of the fees to postmarket safety. It would also strengthen FDA's ability to monitor and remedy false and misleading television ads for drugs and toughen labeling requirements to ensure that labels reflect study results in a timely and consistent fashion. In addition, the legislation would create a public, searchable database of clinical trials for drugs and medical devices to be administered by NIH. With the exception of preliminary studies, all trials would have to be registered. The bill is a compromise between House and Senate versions passed earlier this year and is expected to pass quickly in the Senate.