Woodcock: FDA may have misstepped before Alzheimers drug approval – STAT

https://www.statnews.com/2021/07/14/woodcock-fda-may-have-misstepped-process-alzheimers-drug-approval/


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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. She pushed back on a follow up question, too, saying I think we ought to move on,” and, later, “This is an interrogation right now.”

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.

Asked more broadly about how the FDA could address the pharmaceutical industry’s efforts to influence its regulatory decisions, Woodcock said that while the agency was well aware of that push, it is focused on the data.

“Drug makers are very eager to get their drugs approved, and they have various strategies that they pursue and the FDA is quite aware of this,” she said. “We look at the data that’s before us and we verify those data, and that’s been our long standing procedure and process. … We believe our decisions are based on the data in front of us and the standards that we have.”

On Covid-19 and the potential need for booster shots

Pfizer has suggested that its own, unpublished data shows waning immunity to the Covid-19 vaccine — and therefore supports the controversial idea of a third “booster” shot. It and Moderna are both studying the option right now.

Woodcock, however, was firm, saying that vaccinated Americans shouldn’t worry about the need for a booster right now.

“We don’t think that boosters are needed at the current time, and we will follow the data, the data on waning of immunity over time and the data on acquisition of inspections by the vaccinated, to see if at some point it appears that a booster would be warranted.”

Asked, as a follow-up, whether the FDA can keep working as hard and as fast as it did during the Covid-19 pandemic, Woodcock was clear: No.

“People were working 24-7. We can’t work for people until they drop, we won’t have any staff. So that is not sustainable. Obviously with greatly increased resources we could probably move somewhat faster, but there is a limit,” she said. “Much of the speed, remember, of drug development and so forth was within the execution of the clinical trials, and that had to do with really putting a lot of resources against getting those things done, particularly the vaccines.”

She added, however, that she’d like to see some of the flexibilities of teleworking remain, even after the pandemic.

On what’s next for her

Woodcock, a longtime veteran of the FDA, is a rumored contender for the nomination to full commissioner of the agency. But if she isn’t nominated by November, she’ll have to step down, she acknowledged Wednesday.

“Well, of course, there’s a goal of having good continuity,” she said. “Some of the work that I’m working on now, which include the really, instantiation of the modernization plans for both infrastructure and data, will, will be long term projects that will need to go on.”

Erin Mershon contributed reporting. 


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