House Passes FDA Package Reauthorizing Drug, Device User Fees

The House on Wednesday passed a sweeping package to reauthorize the fees that help fund the FDA as the Senate works to pass its own version of the bipartisan legislation.

House members voted 392-28 under suspension of the rules to pass the legislation (H.R. 7667). The measure would set a $1.15 billion base fee amount for human prescription drugmakers for fiscal 2023, and revamp the FDA’s accelerated approval pathway that gained renewed scrutiny after Biogen Inc.‘s Alzheimer’s drug approval. It also includes provisions to improve diversity in clinical trials.

The vote marks a pivotal step in reauthorizing ...