STAT+: Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions

House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s accelerated approval pathway, but their latest legislation is friendlier to industry than previous drafts.

WASHINGTON — House lawmakers are moving a little closer toward cracking down on drugmakers that game the FDA’s accelerated approval pathway, but their latest legislation is friendlier to industry than previous drafts.

The House Energy and 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.

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