Health Care

Woodcock: FDA may have misstepped before Alzheimer’s drug approval

WASHINGTON — Acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in its handling of its polarizing approval of a new Alzheimer’s drug.

She was emphatic in her defense of the therapy and the agency’s approval decision in an interview at STAT’s Breakthrough Science Summit, but said “it’s possible that the process could have been handled in a way that would have decreased the amount of controversy involved.”

“Was the process done exactly the best that it could be?” she said. “Possibly not.”

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The FDA’s approval of the drug, Aduhelm, has been mired in controversy after controversy since its approval last month. Already, the agency has had to narrow the patient population for whom the drug is approved; late last week, Woodcock also called for an independent watchdog to investigate the actions that led to the drug’s approval, after a STAT investigation revealed close coordination between Biogen, the drug maker, and FDA regulators.

In the interview Wednesday, Woodcock was clear in her support for the drug approval itself.

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“The accelerated approval was based on very solid grounds,” she said. “I do believe that will play out over time, as people see that was a very appropriate use of that authority and the right thing to do for patients.”

But she also deflected questions about whether she was aware of a May 2019 off-the-record meeting between an FDA regulator she supervised and Biogen, which STAT first reported.

“I was working in Operation Warp Speed all of last year, all right, as the therapeutic lead. And I’m not going to comment on my awareness or elsewise,” Woodcock said.

Operation Warp Speed was launched to expedite development of products related to Covid-19 in May 2020, after the off-the-books meeting on Aduhelm occurred.

The acting commissioner also defended the FDA’s decision to approve Biogen’s controversial Alzheimer’s drug for a wide range of patients outside of those studied during clinical trials. The decision surprised even some senior FDA officials, STAT reported last week.

It’s more common for the FDA to approve a drug for a broader patient population for a drug in the neurodegenerative disease space, Woodcock contended.

“In this case I think after getting feedback, they realize they should be more descriptive about who was in the trial and what was known about those not in the trial,” Woodcock said.



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