WASHINGTON (AP) – The acting director of the Food and Drug Administration on Friday called for a government investigation into highly unusual contacts between her agency’s drug reviewers and the maker of a controversial new Alzheimer’s drug.
Dr. Janet Woodcock announced the extraordinary move on Twitter. It is the latest sequel to last month’s approval of Aduhelm, an expensive and unproven therapy that the agency approved against the advice of its own outside experts.
Woodcock made the request to the inspector general of the Department of Health and Human Services, the watchdog agency that oversees the FDA and other federal health agencies. The move comes after numerous inquiries about approval from medical experts, consumer advocates and members of Congress. Two Congressional committees have already launched their own review.
“We believe that an independent evaluation is the best way to determine if any interaction that occurred between the manufacturer and the agency’s review staff was inconsistent with FDA policies and procedures,” Woodcock wrote on Twitter. Biogen agreed to cooperate with the investigation.
Last month, the health news site Stat reported on the unusually close collaboration between Aduhelm’s drug maker, Biogen, and FDA staff. Notably, the site reported an “off the books” meeting in May 2019 between a senior Biogen executive 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 expected. Biogen and the FDA began re-analyzing the data together, concluding that the drug might work. The collaboration ultimately led to the drug’s conditional approval two years later, on the grounds that it reduced the build-up of sticky plaque in the brain that is believed to play a role in Alzheimer’s disease.
FDA interactions with pharmaceutical industry personnel are tightly controlled and almost always carefully documented. It’s unclear whether the May 2019 meeting violated agency rules.
When Biogen and the FDA brought the drug before the FDA’s external advisory panel 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 senior staff reviewer, who had been working with Biogen for months on the drug data, called it “exceptionally persuasive,” “very positive,” and “robust.”
Consumer advocacy group Public Citizen called for an investigation into the collaboration after the November advisory meeting. The group’s health director, Dr. Michael Carome, welcomed Woodcock’s request for an investigation.
“We are pleased to see that you belatedly made this request that should have been made months ago,” Carome said. “The signs of inappropriate collaboration have been clear to us since November.”
Three of the FDA advisers who opposed the drug resigned over the decision. Among other issues, they protested that the agency did not disclose that it was considering approving the drug conditionally, based on its effect on brain plaque, rather than any actual benefit to patients. Aduhelm is the first Alzheimer’s drug approved in this way.
“I think all the different parts of the decision are worth independent investigation,” said Harvard University researcher Dr. Aaron Kesselheim, one of 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 vastly reducing prescribing information on the drug. The agency and Biogen announced that the new label would recommend that it only be given to patients with mild or early-stage Alzheimer’s. That came after many doctors criticized the original label for being too broad, saying the drug could be given 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 buildup in the brain will likely slow dementia. More than two dozen other drugs have previously tried that approach without producing positive results. Biogen is required to conduct a follow-up study to definitively answer if it really works. Other medications for Alzheimer’s disease only temporarily relieve symptoms.
Woodcock has served as the agency’s acting commissioner since January. He previously spent more than 25 years running the agency’s drug center. While highly respected in government and pharmaceutical industry circles, she has also come under fire for aggressively lobbying for new therapies to be approved, even when their benefits are uncertain.
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