FDA head calls for inspector general investigation of agency’s dealings with Biogen, maker of controversial new Alzheimer’s drug - The Washington Post

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Janet Woodcock, acting commissioner of the Food and Drug Administration, on Friday asked for the inspector general to conduct an “independent review and assessment” of the agency’s interactions with the maker of a controversial new Alzheimer’s drug, whose approval has set off a torrent of criticism.

Woodcock said on Twitter she was requesting the review because of the “ongoing interest and questions” about the approval of the drug, called Aduhelm, on June 7. She said the review would focus on interactions between representatives of Biogen and the FDA during the process that led to the approval.

In a letter to the Office of Inspector General at the Department of Health and Human Services, Woodcock said there has been “significant attention and controversy surrounding the process” for Aduhelm.

She said she had “tremendous confidence in the integrity of the staff and leadership” of the agency involved in the approval but added that questions continue to be raised about contacts between Biogen and the FDA, “including some that may have occurred outside of the formal correspondence process.”

Stat, a website covering medical and science news, reported last month that there was an informal meeting in May 2019 between Alfred Sandrock Jr., a top Biogen official, and Billy Dunn, the head of the FDA’s neuroscience office, at a conference in Philadelphia.

The news site also said the agency early in the approval process outlined several possible paths to clearance, including accelerated approval — even though officials told an outside advisory committee later that the option was not under consideration.

Critics say there is scant evidence that the drug, which received accelerated approval from the FDA, will slow cognitive decline in patients, which is what the medication was designed to do. They have accused the FDA of bending over backward to clear the treatment, contending that regulators worked too closely with Biogen to get the drug on the market.

The controversy has been exacerbated by the list price — $56,000 a year per patient — which many worry could jeopardize the financial health of Medicare.

The FDA on Thursday moved to quell some of the outcry by limiting the recommended use of the drug to patients with mild cognitive impairment or early dementia from the disease — a major change from the original label that included anyone with the illness.

The revised label clarifies that Aduhelm is intended for patients with early-stage disease — the population that participated in clinical trials of the drug. It is the first Alzheimer’s medication cleared since 2003.

The narrower label limits the recommended population eligible for the drug to 1 million or 2 million Alzheimer’s patients, rather than the more than 6 million people with Alzheimer’s in the United States, Michael Yee, a biotech analyst for the financial services company Jefferies, said in a note to investors.

The agency approved the drug despite a recommendation from an outside advisory committee that FDA reject the medication. Three members of the panel resigned following the approval, saying they strenuously disagreed with it. Members of Congress have called for investigations into the approval.

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FDA head calls for inspector general investigation of agency’s dealings with Biogen, maker of controversial new Alzheimer’s drug - The Washington Post
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