ICER Whitepaper Proposes Improvements to the FDA’s Accelerated Approval Pathway

The Institute for Clinical and Economic Review (ICER) has released a whitepaper proposing policy reforms that would improve the Food and Drug Administration’s Accelerated Approval Program (AAP). These changes include revising how surrogate endpoints are selected, creating a “safety-only” designation, and tying a drug’s price to its value.

ICER President Steven Pearson remarks, “So today, after nearly three decades of experience, it is a good time to take stock of where the AAP is, and what might be done to strengthen it. No policy reform options come without potential downsides, and the goal of our white paper is to outline the potential benefits and risks of major policy options.” Read more here.

(Source: ICER, 5/26/21)