Two House committees on Monday requested a slew of documents from the pharmaceutical company Biogen as part of an investigation into the controversial approval of its Alzheimer's treatment.
House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) and House Oversight Committee Chairwoman Carolyn MaloneyCarolyn MaloneyOvernight Defense & National Security: US-Australian sub deal causes rift with France Overnight Energy & Environment — Presented by Climate Power — Emissions heading toward pre-pandemic levels Oversight Republicans seek testimony from Afghanistan watchdog MORE (D-N.Y.) wrote to Biogen CEO Michel Vounatsos on Monday requesting the documents concerning the Alzheimer's drug, Aduhelm.
“We are concerned by reports of an atypical approval process for Aduhelm amid significant questions about the drug’s clinical benefit, and the steep $56,000 annual price tag, which will have serious implications for seniors, federal health care programs, and future Alzheimer’s research," the lawmakers wrote.
The letter points to reporting from Stat finding that Biogen engaged in "a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm."
Among the documents requested are documents relating to Project Onyx and records of all calls and meetings between Biogen and Food and Drug Administration officials related to the drug.
The lawmakers also seek documents about the pricing of the drug, which at $56,000 per year has drawn an outcry, especially because there are doubts about whether the drug actually works.
The congressional letter is the latest turn in the controversy surrounding the FDA's approval of the drug, both over the price and whether the evidence on its effectiveness justified approving it. The FDA's outside expert advisory committee had recommended against approval.
Acting FDA Commissioner Janet Woodcock last week requested an inspector general investigation as well.