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# Woodcock: Aduhelm Process Could Have Been Better
- URL: https://www.fdaweb.com/woodcock-aduhelm-process-could-have-been-better/
- Published: 2021-07-14T12:00:00.000Z
- Updated: 2026-09-14T17:06:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149713

In a somewhat contentious interview with *Stat News*, FDA acting commissioner **Janet Woodcock** defended the agency’s decision to approve Biogen’s controversial Alzheimer’s treatment Aduhelm (aducanumab) 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? Possibly not.”

*Stat* says that in her [interview](https://www.statnews.com/2021/07/14/woodcock-fda-may-have-misstepped-process-alzheimers-drug-approval/?ref=fdaweb.com), Woodcock was clear in her support for the drug approval decision. “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.”

However, she deflected questions about her knowledge of a 5/2019 off-the-record meeting between an FDA regulator she supervised and Biogen that was first reported by *Stat*. Woodcock indicated she had been working with Operation Warp Speed on the Covid-19 vaccines and would not comment on her awareness of other things.

She pushed back on a follow-up question, *Stat* says, saying, “I think we ought to move on” and later “this is an interrogation right now.”

Woodcock defended FDA’s initial decision to approve Aduhelm for a wide range of patients outside those studied in clinical trials, saying it’s more common to approve a drug for a broader patient population if the drug is in the neurodegenerative disease space.

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

Asked more generally about how the agency could address drug industry efforts to influence regulatory decisions, Woodcock insisted FDA remains focused on the data. “Drugmakers are very eager to get their drugs approved, and they have various strategies that they pursue and 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.”