Regulatory rheostats key to meeting promise of expedited approvals
Better mechanisms are needed to dial in appropriate access based on postmarket evidence
Mounting frustration with the accelerated approval process, brought to the public’s attention by the controversial decision on Biogen’s Aduhelm, is sparking debates inside and outside FDA about ways to improve the pathway. The discussions include proposals to put more flexibility into systems for adjusting access to drugs based on evidence collected after approval.
Ideally, regulatory rheostats would allow FDA to modify access to medicines approved through its accelerated pathway, with a range of options from redefining the patient population who can receive them to withdrawing approval altogether...