House committees kick off investigation into how Biogen's Aduhelm won approval
Two key House committees — on Oversight and Reform, and Energy and Commerce — have now officially opened their own investigation into the approval of Biogen’s new Alzheimer’s drug Aduhelm by asking the company for a variety of different internal and external documents and communications relating to assessments of the drug’s safety, efficacy, or clinical benefit.
The committees are specifically targeting the way in which the FDA used the accelerated approval pathway to sign off on Aduhelm, despite not questioning its panel of outside experts (three of whom have since resigned) on whether such an accelerated approval would be appropriate.
To do that, they’re seeking documents from Biogen relating to the use of amyloid beta plaque reduction as a surrogate endpoint for the treatment of Alzheimer’s disease, including whether such plaque reduction predicts efficacy in treating cognitive decline. They’re also seeking further documents on the drug’s price and how Biogen came to its determination on the price, given that ICER said a fair price would be between $3,000 per year — if the drug is not as effective as promised — to $8,400, if it is.
“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,” Rep. Frank Pallone (D-NJ), chairman of the E&C committee, and Rep. Carolyn Maloney, chair of the Committee on Oversight and Reform, said in a statement.
As Biogen may have turned to some backdoor dealings with the FDA as part of early efforts to get Aduhelm across the finish line, the committees are seeking the dates, times, locations, attendees, and any notes or minutes taken of all calls and informal and formal meetings or discussions among FDA officials and representatives of Biogen.
News of this congressional investigation coincides with a separate investigation from HHS’ Inspector General, at the request of acting FDA commissioner Janet Woodcock, and FDA’s recent decision to narrow the drug’s label as part of an attempt to calm at least some of its fiercest critics.