The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen's Alzheimer's drug Aduhelm, which was 'rife with irregularities,' a congressional report showed on Thursday.
A sign marks a Biogen facility in Cambridge, Massachusetts, U.S., March 9, 2020. REUTERS/Brian Snyder/File PhotoWASHINGTON, Dec 29 - The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen's
The FDA approved Aduhelm in June 2021 under an accelerated approval pathway over the objections of its panel of outside advisers, who did not believe data definitively proved the drug's benefit to patients. Biogen set an "unjustifiably high" price by initially setting Aduhelm's price at $56,000 per year despite a lack of demonstrated clinical benefit in a broad patient population, the report said, adding that the company's own internal projections showed it expected the drug to be a burden to Medicare and costly to patients.
Biogen and other drugmakers should communicate to the FDA any concerns over safety and efficacy to the FDA as well as take value and patient access into consideration when setting prices, the report said. Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.
"Using a joint briefing document afforded Biogen advance insight into FDA's responses and direct guidance from the agency in drafting the company's own sections. For example, in an exchange of the draft briefing document on October 9, 2020, FDA staff asked Biogen to move a paragraph drafted by the agency into Biogen's section of the memorandum—a change reflected when the document was finalized," the report made public to media organizations said.
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