Bloomberg Law
May 27, 2022, 7:07 PM

Fast Drug Approvals Would Get Revamp in Senate’s FDA Fee Bill

Celine Castronuovo
Celine Castronuovo

The FDA would have more power to push for post-market studies of drugs cleared through its accelerated approval pathway in a Senate package unveiled Friday to reauthorize the fees that help fund the agency.

The accelerated approval changes in the proposal by Sens. Patty Murray (D-Wash.) and Richard Burr (R-N.C.), chair and ranking member of the Senate’s health committee, were among the provisions added to their discussion draft released last week.

The package would also expand authorities for the Food and Drug Administration over lab-developed tests and dietary supplements. Congress must pass the legislation before the current user fee agreements ...