The Policy Catalyst
Accelerated approval has been the FDA's greatest gift to biotech: get a drug to market on a surrogate endpoint — a lab marker, not survival data — and confirm real-world benefit later. Congress codified tighter withdrawal timelines in the 2022 omnibus spending package, and the pressure has not let up. Lawmakers on both sides of the aisle have pushed FDA to enforce mandatory post-market confirmatory trial deadlines and to pull drugs faster when those trials stall. The result is a structural repricing of the accelerated-approval pipeline. Companies with already-confirmed outcomes are insulated. Companies running on unconfirmed surrogate endpoints are carrying hidden regulatory risk that the market has not fully priced.