Drugs

House Chairs Want Aduhelm Info from FDA

David McFarland

— 1 min read
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House Energy and Commerce Committee chair Frank Pallone (D-NJ) and Oversight and Reform Committee chair Carolyn Maloney (D-NY) have written to FDA acting commissioner Janet Woodcock seeking answers to 15 detailed questions on the agency’s review process and accelerated approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab). “We are concerned by apparent anomalies in FDA’s processes surrounding its review of Aduhelm,” the letter says. “FDA granted accelerated approval for the drug despite concerns raised by experts, including the agency’s own staff and members of FDA’s Peripheral and Central Nervous Systems Drugs Advisory Committee, about the drug’s clinical benefit and the use of the accelerated approval pathway for Aduhelm. We are also concerned by reports of unusual coordination between FDA and Biogen throughout the drug’s approval process.”

Information sought from FDA includes:

  • an explanation of how FDA reconciles its determination that Aduhelm met the criteria for accelerated approval with the views of the advisory committee, internal experts from FDA’s Office of Biostatistics, and some of the nation’s largest medical centers and insurers, all of whom have determined that there are insufficient data on the safety and efficacy of Aduhelm;
  • FDA’s process or related policies in place for making an approval determination when there is FDA staff disagreement with the relevant advisory committee and/or when there is internal disagreement among the relevant FDA expert reviewers, including information on whether Aduhelm’s approval deviated from this process and these policies;
  • details of when FDA first discussed the potential use of the accelerated approval pathway for Aduhelm internally and with Biogen and who was a part of such discussions;
  • documents related to any internal agency reviews or assessments concerning interactions between FDA personnel and Biogen related to the approval of Aduhelm;
  • FDA’s internal discussions and process for approving Aduhelm for a broader treatment indication than what was studied in the clinical trials and for updating Aduhelm’s label post-approval; and
  • a list of all formal and informal conversations and meetings between FDA and any representative of Biogen and all documents, including communications, related to those conversations since 1/2018, as well as an explanation for why any such meetings were not memorialized in keeping with FDA best practices.

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