14 February 2022 - Lawmakers could revamp the fast-track FDA process used to approve Biogen’s Alzheimer’s drug under must-pass legislation to reauthorise the agency’s user fees.

The House is weighing a proposal to renew the Prescription Drug User Fee Act, which allows the FDA 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.

Read Bloomberg article