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Acting FDA Commissioner calls for independent investigation into Alzheimer’s drug approval

In one letter Posted on Twitter, Woodcock said an independent review and assessment should take into account interactions between Biogen, the company that makes Aduhelm, and the FDA during the process that led to the drug’s approval in June.

Woodcock wrote that she had “tremendous confidence in the integrity of the staff and leadership” of the FDA’s Center for Drug Evaluation and Research involved in the review of the drug, aducanumab, and sold under the name of Aduhelm.

“However, concerns continue to be raised regarding contacts between Biogen and FDA officials during the review process, including some that may have taken place outside of the form matching process,” wrote Woodcock to Acting BIG Inspector Christi Grimm.

“To the extent that these concerns could undermine public confidence in the FDA’s decision, I believe it is essential that the events in question be reviewed by an independent body such as the Office of Inspector General to determine whether any interactions that occurred between Biogen’s review staff and the FDA did not comply with FDA policies and procedures. “

Acting FDA Commissioner calls for independent investigation into Alzheimer’s drug approval
At TwitterWoodcock said if the HHS OIG decides to proceed with the review, the agency will “fully cooperate” and consider any recommendations it may provide.

A spokesperson for Biogen said in a statement to CNN: “We will, of course, cooperate with any investigation into a possible review of the regulatory process.”

An FDA request does not guarantee that there will be an investigation. In a statement, a spokesperson for HHS OIG said the office has received Woodcock’s letter and is reviewing it to take appropriate action.

On June 7, aducanumab was approved with FDA “fast-track approval” to treat Alzheimer’s disease, despite an earlier FDA advisory committee vote that there was not enough evidence to support the clinical efficacy of the drug. Three members of the advisory committee resigned following the approval decision. Biogen has also been the subject of price criticism – a high dose is expected to cost $ 56,000 per patient per year.

Later in June, two House committees launched an investigation into Aduhelm’s approval and price, saying there were serious concerns about the price of the treatment and the process that led to the approval.
Also in June, the health news site STAT reported that there had been informal meetings between Biogen and the FDA prior to the drug’s approval that may have violated FDA protocol. In its response to STAT, Biogen said, “We adhere to and have followed FDA guidelines, regulations and processes when reviewing Aduhelm’s biologics license application.


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