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House passes bill to empower FDA, renew industry user fees

by Glenn Hess
July 16, 2007 | A version of this story appeared in Volume 85, Issue 29

Last week, by a vote of 403 to 16, the House approved bipartisan legislation giving FDA new powers to regulate drugs after they reach pharmacy shelves. It would also renew, through 2012, a program that requires the drug industry to pay the agency nearly $400 million in annual user fees to help defray the cost of reviewing prospective new medicines.

In the wake of the Vioxx withdrawal in 2004 and subsequent problems with several other drugs already on the market, lawmakers seized on the legislation to overhaul how FDA deals with the safety of the products it regulates.

The Senate approved similar legislation in May, and differences between the two versions will have to be reconciled before lawmakers send a final measure to the White House for the President's signature.

Both bills would give FDA more authority to track safety problems that can arise after drugs become available to the general patient population. The agency could also force pharmaceutical manufacturers to make label changes and conduct follow-up studies on certain medicines.

The House bill goes beyond the Senate version in several respects. For instance, it would require FDA to periodically review the safety of drugs after they are initially approved, and the agency could make drug companies submit their television advertisements for review prior to airing them. FDA could also fine drug makers up to $500,000 for false or misleading ads.


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