As Medicare officials review evidence about Biogen’s (NSDQ:BIIB) Aduhelm (aducanumab) to determine if and how it will cover the drug, two high-level House Democrats are asking Biogen about its dealings with FDA.
Yesterday, Carolyn Maloney (D-N.Y.) and Frank Pallone, Jr. (D-N.J.) sent a letter to Biogen CEO Michel Vounatsos asking for details about the company’s communications with FDA staff before it filed a Biologics License Application for aducanumab. Maloney chairs the House Committee on Oversight and Reform, while Pallone chairs the House Committee on Energy and Commerce.
The House isn’t alone in its push for such information regarding the drug, which could cost patients $56,000 annually in out-of-pocket expense. Acting FDA Commissioner Dr. Janet Woodcock recently asked the Office of Inspector General to launch an independent review of the agency’s dealings with Biogen during the Aduhelm approval process.
Public Citizen recently filed a letter to C…