US Congress to investigate FDA’s approval of Biogen’s Alzheimer’s drug

pharmafile | September 3, 2021 | News story | Medical Communications  

The US Congress has requested data and documents from the FDA in relation to its accelerated approval of the controversial Alzheimer’s drug made by Biogen, Aduhelm.

In addition to a huge backlash from experts, charities, patients, doctors, FDA panel members, and an internal investigation from the FDA itself, this adds additional pressure to the agency for approving the drug.

The chairs of the House Committee on Oversight and Reform and the Committee on Energy and Commerce have requested the FDA to disclose documents related to the interactions between Biogen and the agency’s staff.

House Committee on Oversight and Reform said in a statement: “We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit.”

Biogen said it will “of course cooperate with any inquiry we may receive from these committees,” in response to a Reuters request for comment.

The drug, which has a high list price of $56,000 per year, was approved by the US regulators as the first treatment to attack a likely cause of Alzheimer’s on 7 June.

The letter, dated 1 September, also requests for details on the agency’s process for approving a therapy when there is a disagreement known between the FDA staff and its panel of external advisers, known as the advisory committee.

Three of the 11 members of FDA’s independent advisory panel have resigned in protest over the agency’s decision.

Shares of the drug maker were down nearly 1% in after-market trading.

Lilly Subbotin

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