Biogen Alzheimer Drug Row Augers Flux in Fast FDA Approvals (1)

Lawmakers could revamp the fast-track FDA process used to approve Biogen’s Alzheimer’s drug under must-pass legislation to reauthorize the agency’s user fees.

The House is weighing a proposal to renew the Prescription Drug User Fee Act, which allows the Food and Drug Administration to collect fees from brand-name pharmaceutical companies to help fund agency operations. Lawmakers spent much of the first hearing on the matter focused on the Aduhelm approval that had attracted renewed scrutiny to the accelerated pathway program.

“I would not be surprised at all to see some reforms to the accelerated approval process as part of the ...