Congress Report Says FDA Broke Protocols In Approval Of Biogen Alzheimer's Drug

The US Food and Drug Administration’s approval process for Biogen’s controversial Alzheimer’s drug Aduhelm was “rife with irregularities,” a congressional report said.

Oversight and Reform Committee Chairwoman Carolyn Maloney and Energy and Commerce Committee Chairman Frank Pallone, Jr. released a staff report following an 18-month investigation into FDA’s regulatory review and approval process of Aduhelm as well as Biogen’s pricing of the Alzheimer’s drug.

“This report documents the atypical FDA review process and corporate greed that preceded FDA’s controversial decision to grant accelerated approval to Aduhelm.” Chairman Pallone said.

The report also said that Biogen “initially set an unjustifiably high price for Aduhelm, at $56,000 per year, to ‘make history’ for the company, despite the impact on patients and the Medicare program.”

Aduhelm was surrounded by controversies since the U.S. FDA approved it for the treatment for Alzheimer’s in June last year. It was the first drug to be approved in 18 years for the disease.

FDA’s gave its approval despite objections from its advisory Peripheral and Central Nervous System Drugs Advisory Committee. At least three members of the panel resigned in protest of the agency’s decision.

The development of the Alzheimer’s drugs was plagued by high failure rate. In March 2019, Biogen and Eisai had discontinued their global late-stage trials based on results of a futility analysis, which indicated the trials were unlikely to meet their primary endpoint upon completion.

The report says that documents and information obtained by the Committees show that FDA considered Aduhelm under the traditional approval pathway used for most drugs for nine months, before abruptly changing course and granting approval under the accelerated approval pathway after a three-week review period.

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