Fast Drug Approvals Would Get Oversight Boost in Budget Proposal

The FDA is seeking to add more stringent postmarket study requirements for the pathway used to approve Biogen Inc.'s Alzheimer’s drug.

As part of President Joe Biden‘s fiscal 2023 budget request, the Food and Drug Administration said it wants the authority to mandate that drugmakers, as a condition of winning accelerated approval for a product, show their post-approval studies are adequately designed to verify the drug’s clinical benefit.

The agency said such a move could help improve the effectiveness of the regulatory process, which has come under increased scrutiny over whether the treatments it brings to market benefit ...