Bloomberg Law
May 11, 2022, 9:47 AM

BGOV OnPoint: House Panel Takes Up FDA User Fee Reauthorization

Christina Banoub

The five-year authorization of Food and Drug Administration user fees, which fund a significant part of its drug and device approval programs, is set to expire Sept. 30.

The FDA negotiates with industry to set the fees, which Congress authorizes through legislation, along with goals for review times.

Download the BGOV OnPoint: FDA User Fee Reauthorization

House Energy and Commerce leaders released a bipartisan package (H.R. 7667) that would reauthorize FDA user fees, with a subcommittee markup scheduled for May 11.

The bill would also make changes aimed at reducing drug prices, increasing the availability of generics, and ...