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.
The FDA’s accelerated approval program allows the agency to approve drugs without clear evidence they help patients live longer. The pathway has always been controversial, but those criticisms exploded after the FDA approved Biogen’s controversial Alzheimer’s drug, Aduhelm, using accelerated approval.
About the Author Reprints
Create a display name to comment
This name will appear with your comment
