STAT+: Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions
WASHINGTON — House lawmakers are moving a little closer toward cracking down on drug makers that game the FDA’s accelerated approval pathway, but their latest legislation is friendlier to industry than previous drafts.
The House Energy & Commerce Committee announced Wednesday that its sweeping user fee authorization bill will include a revised policy from Rep. Frank Pallone (D-N.J.) that would make it easier for the Food and Drug Administration to rescind its approval for drugs cleared through the pathway when drug makers don’t complete required follow-up studies.
