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The acting head of the U.S. Food and Drug Administration has taken the unusual step of calling for an independent investigation into the agency’s interactions with Biogen executives in the run-up to the drug’s approval. Alzheimer’s Company.
Janet Woodcock, the FDA’s acting chief, wrote Friday to the inspector general of the Department of Health and Human Services asking for a review of the correspondence between its staff and Biogen executives, as questions are raised as to why the regulator approved controversial drug.
Agency pressure had increased after Stat News last month reported that Biogen had held an off-book meeting in 2019 with Billy Dunn, head of the FDA’s neuroscience division, to ask for his support for the treatment now known as Aduhelm.
Biogen shares fell 3% in the afternoon trading in New York.
Last month, the FDA gave the green light to Biogen’s Alzheimer’s drug, making it the first authorized treatment for the disease in nearly 20 years. The agency later was left under fire of scientists who said the drug should not have been approved because there is little evidence that it works.
Some critics argued that the approval was a sign that the FDA is too close to the pharmaceutical industry.
Woodcock wrote Friday that he had “tremendous confidence” in his staff’s commitment “to impartial, science-based decision making.” But he noted that there were concerns “about contacts between Biogen representatives and the FDA during the review process, including some that may have occurred outside the formal correspondence process.”
He urged the review to begin “as soon as possible.”
Woodcock’s call for an investigation comes a day after the FDA changed its prescription recommendations for the drug. Initially, the agency had recommended that it be given to anyone with Alzheimer’s, but on Thursday it said treatment should only be started for people suffering from mild forms of the disease.
The FDA made the change after Biogen took the very unusual step of asking the agency to restrict the so-called drug label.
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