Under the bill, the FDA can require post-approval studies of new drugs or order additional warnings. Drugmakers that fail to follow FDA directives could face fines as high as $50 million. Running a false or misleading advertisement to consumers could draw fines of $250,000.
"This legislation strikes the proper balance between new drug safety regulations and measures, and ensuring consumers have the access to innovative prescription pharmaceuticals without undue delay," said Rep. John Dingell, a Michigan Democrat and chairman of the House Energy and Commerce Committee, according to Reuters.
The new authority for the FDA was among provisions meant to improve the government's drug safety oversight, increase transparency of company clinical trials and raise the fees that manufacturers pay to help speed reviews of medicines and medical devices.
Lawmakers crafted the legislation in response to complaints about the FDA's handling of serious side effects seen after drugs hit the market. The agency was criticized as slow to act on signs of problems with Vioxx, which was withdrawn in 2004, and other meds.
Pharmaceutical companies and the FDA had proposed $393 million in fees for each of the next five years to speed agency reviews and help fund safety monitoring after approval. Under the House bill, companies would pay an extra $225 million over five years specifically for post-approval checks.
The Senate bill differs from the House plan in part by capping fines at $2 million and setting lower drugmaker fees. Lawmakers are expected to work out differences between the House and Senate versions before the current fees expire in September. Pharma has generally supported the bill; drugmakers favor extending the fees they pay the FDA because they help cut product review times.