The acting head of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between his agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug.
Dr. Janet Woodcock announced the extraordinary move via Twitter. It is the latest consequence of Aduhelm’s approval last month, an expensive and unproven therapy that the agency accepted against the advice of its own external experts.
Woodcock made the request to the inspector general of the Department of Health and Human Services, the surveillance agency that oversees the FDA and other federal health agencies. The move comes after numerous probe requests for approval from medical experts, consumer advocates and members of Congress. Two congressional committees have already launched their own review.
“We believe an independent evaluation is the best way to determine if the interactions that occurred between the manufacturer and the agency’s review staff were inconsistent with FDA policies and procedures,” Woodcock said. he wrote on Twitter. Biogen undertook to cooperate with the research.
Last month, the health news site Estad reported on the unusually close collaboration between pharmacist Aduhelm Biogen and FDA staff. In particular, the site reported an “out-of-book” meeting in May 2019 between one of Biogen’s top executives and the FDA’s lead reviewer for Alzheimer’s drugs.
The meeting came after Biogen stopped two studies because the drug did not appear to slow the disease as intended. Biogen and the FDA began reanalyzing the data together, concluding that the drug could work. The collaboration eventually led to conditional approval of the drug two years later, on the grounds that it reduced the buildup of sticky plaque in the brain that is believed to play a role in Alzheimer’s disease.
FDA interactions with pharmaceutical industry personnel are strictly controlled and almost always carefully documented. It is unclear whether the May 2019 meeting violates the agency’s rules.
When Biogen and the FDA filed the drug before the FDA’s panel of external advisors in November, the group was almost unanimous in urging its rejection.
The FDA is not required to follow the group’s advice. And the FDA’s chief staff reviewer, who had been working with Biogen on the drug’s data for months, described it as “exceptionally persuasive,” “strongly positive,” and “robust.”
The consumer advocacy group, Public Citizen, called for an investigation into the collaboration after the November consultative meeting. The group’s health director, Dr. Michael Carome, welcomed Woodcock’s request for research.
“We’re pleased to see how late he made this request that should have been made months ago,” Carome said. “The signs of inadequate collaboration have been clear to us since November.”
The FDA has clashed intense reaction since he approved the drug, which costs $ 56,000 a year and requires monthly IVs.
Three of the FDA advisers who opposed the drug waived the decision. Among other issues, they protested because the agency did not disclose that it was considering approving the drug conditionally, based on its effect on the brain plaque, rather than any real benefit to patients. Aduhelm is the first Alzheimer’s drug approved in this way.
“I think all parts of the decision are worthwhile for an independent investigation,” said Dr. Aaron Kesselheim, a Harvard University researcher, one of the three advisers who resigned. “The confidence we have in the FDA’s ability to make independent decisions is very important.”
On Thursday, the FDA took the unusual step of greatly reduced prescription information about the drug. The agency and Biogen announced that the new label would recommend that it be administered only to patients with early or mild Alzheimer’s. This came after many doctors criticized the original label for being too broad, as it said the drug could be administered to anyone with Alzheimer’s.
Aduhelm has not been shown to significantly reverse or slow the disease. But the FDA said its ability to reduce plaque clusters in the brain is likely to slow dementia. More than two dozen drugs have previously tested this approach without yielding positive results. Biogen is needed to carry out a follow-up study to definitely answer if it really works. Other Alzheimer’s medications only temporarily relieve symptoms.
Woodcock has been the agency’s acting commissioner since January. He previously spent more than 25 years running the agency’s drug center. Although it is widely respected among the government and drugs in industry circles, he has also been criticized for often pressuring aggressively to approve new therapies, even when their benefits are uncertain.
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