FDA head calls for inspector general investigation of agency's dealings with Biogen
Source: Washington Post
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.
Read more: https://www.washingtonpost.com/health/2021/07/09/aduhelm-new-alzheimers-drug-hhs-inspector-general/
Full headline: FDA head calls for inspector general investigation of agency’s dealings with Biogen, maker of controversial new Alzheimer’s drug
