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Committees Seek Information

Two congressional committees are seeking information about the US Food and Drug Administration's approval of Biogen's Alzheimer's disease treatment Aduhelm, the New York Times reports.

The FDA controversially approved Aduhelm, also known as aducanumab, in June. An advisory committee to the agency had voted months before to reject its approval, saying there was not enough data to determine whether it worked. As Time magazine reported in 2019, Biogen had ended its aducanumab trials after early analyses indicated it did not work but then resurrected the drug when a later re-analysis suggested it may slow cognitive decline in some instances. The approval came under the agency's accelerated approval pathway and led numerous panel members to resign.

The Times previously reported that that FDA and Biogen worked extremely closely on Aduhelm's approval and Stat News suggested there may have been "off-the-books" meetings between them. Acting FDA Commissioner Janet Woodcock has called on the Department for Health and Human Services' Office of the Inspector General for an investigation.

Now, according to the Times, the chairs of the House Committee on Oversight and Reform and the House Energy and Commerce Committee are seeking information about its approval. "We are concerned by apparent anomalies in FDA's processes surrounding its review of Aduhelm," the chairs, Reps. Carolyn Maloney (D-NY) and Frank Pallone (D-NJ), write in a letter to Woodcock, adding that they "are also concerned by reports of unusual coordination between FDA and Biogen throughout the drug's approval process."

FDA says it will work with Congress to respond to the request, Stat News adds.

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