Congress Asks For Approval Documents Of Biogen's Alzheimer's Drug: Report

Lawmakers have requested data and documents from the FDA related to the agency's controversial approval of Biogen Inc's BIIB Alzheimer's drug Aduhelm.
Related: Biogen's New Alzheimer's Drug Turned Away By Veterans Affairs
The Democratic leaders of the House Energy and Commerce Committee and the Committee on Oversight and Reform sent a letter to the agency.
The letter mentioned "significant questions remain" about the June approval of Aduhelm, even after FDA officials met with committee staff in July and provided documents.
"We are concerned by apparent anomalies in FDA's processes surrounding its review of Aduhelm," the committees wrote. "We are also concerned about reports of unusual coordination between FDA and Biogen throughout the drug's approval process."
Citing FDA Chief, STAT News mentioned that Aduhelm's review could have been handled differently.
The Department of Health and Human Services' Office of the Inspector General is conducting a separate inquiry into the drug approval.
Read Next: FDA Requests Probe Into Staff Interactions With Biogen Ahead Of Aduhelm Approval.
Price Action: BIIB shares are down 0.87% at $335.30 during the market session on the last check Thursday.
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