House Approves FDA Overhaul Legislation that Would Improve Prescription Drug Safety
The House on July 18th voted 403-16 to approve a bill that would expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, which expires on Sept. 30. The FDA proposed that pharmaceutical companies pay $393 million in user fees in 2008. The legislation calls for an additional $225 million in user fees from pharmaceutical companies over five years. In addition, the bill would reauthorize the Medical Device User Fee and Modernization Act, which also expires on Sept. 30. The FDA would receive about $287 million in user fees from medical device companies over five years. It would allow FDA to require pharmaceutical companies to conduct post market safety studies of new medications, limit distribution of certain treatments and order product label changes. FDA could fine pharmaceutical companies as much as $250,000 for a single violation of the requirements and as much as $1 million for several violations.
