House panels press Biogen for documents on controversial Alzheimer’s drug


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 Maloney (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.

Background: 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.

Acting FDA Commissioner Janet Woodcock last week requested an inspector general investigation as well.