Proposal would expand FDA oversight, keep user fees

The House has passed a bill that would expand the Food and Drug Administration’s oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, which is set to expire at the end of September.

The legislation would allow the Food and Drug Administration to require pharmaceutical companies to conduct post-market safety studies of new medications, limit distribution of certain treatments and order product label changes. The FDA would be authorized to fine pharmaceutical companies as much as $250,000 for a single violation and as much as $1 million for multiple violations.

Also under the measure, pharmaceutical companies would pay hundreds of millions of dollars in user fees in 2008 to help cover the cost of the FDA’s expanded oversight. The user fees were set to expire Sept. 30, 2007. The Senate approved a similar bill (S. 1082) in May.