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Lawmakers Probe ‘Anomalies’ in Biogen Alzheimer’s Approval (1)

Sept. 3, 2021, 12:01 AM

Leaders of two congressional committees probing the approval of Biogen Inc.’s new Alzheimer’s drug pressed the Food and Drug Administration for more information on “apparent anomalies” in the agency’s review of the $56,000-a-year therapy.

The Democratic leaders of the House Energy and Commerce Committee and the Committee on Oversight and Reform said in a letter to the agency that “significant questions remain” about the June approval of Aduhelm, even after FDA officials met with committee staff in July and provided documents.

Minutes from a meeting of an internal FDA body that the committees obtained showed one agency staffer warned ...