Drugs

Pallone Introduces Bill to Revamp Accelerated Approvals

David McFarland

— 1 min read
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House Energy and Commerce Committee chairman Frank Pallone (D-NJ) has introduced the Accelerated Approval Integrity Act that would revamp FDA’s accelerated approval program. Accelerated approval reform has been under a microscope lately following FDA’s controversial approval for Biogen's Alzheimer’s therapy Aduhelm (aducanumab). It has also become more of a contentious issue at the agency and was raised during the recent confirmation process for now-commissioner Califf, who vowed to crack down on drug companies that gain accelerated approval and then fail to adequately pursue confirmatory evidence as required by the agency in postmarketing commitments (see earlier story). He said that within 30 days of taking office he will “take strong action to hold companies accountable for producing the required scientific evidence after obtaining accelerated approval.”

 

Under Pallone’s bill, FDA would be given additional authority to ensure products that receive accelerated approval are providing a clinical benefit to patients in a timely manner, including:

  • Codifying requirements for manufacturers to conduct post-approval studies on drugs that receive accelerated approval;
  • Requiring manufacturers to enter into an agreement with FDA on how the studies will be conducted before the agency can grant accelerated approval, which may include details like enrollment targets, milestones, and study design;
  • Allowing FDA to require studies to be underway at the time of approval;
  • Requiring more frequent updates on post-approval studies, including updates on enrollment targets, milestones, and study design;
  • Outlining expedited procedures for withdrawing approval, which would include due notice and opportunity for a written appeal to FDA, an opportunity for public comment, and may include FDA convening and consulting an advisory committee;
  • Specifying additional instances in which an accelerated approval can be withdrawn including if a manufacturer fails to achieve agreed upon enrollment targets, milestones, or timely study completion;
  • Automatically expiring accelerated approval status one year after post-approval studies are scheduled to be complete, and in no case later than five years after approval, unless the post marketing study has been completed and verified the clinical benefit
  • Requiring additional information on accelerated approval drugs’ labels; and
  • Making failure to submit reports or act with due diligence on post-approval studies prohibited acts, subject to penalties.

 The bill’s text is available here.

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