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# Woodcock, 2 Others Must Go Over Aducanumab: Public Citizen
- URL: https://www.fdaweb.com/woodcock-2-others-must-go-over-aducanumab-public-citizen/
- Published: 2021-06-16T12:00:00.000Z
- Updated: 2026-09-14T17:03:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149546

Public Citizen says FDA acting commissioner **Janet Woodcock**, CDER director **Patrizia Cavazzoni**, and CDER Office of Neuroscience director **Billy Dunn** should resign or be dismissed over what the advocacy group calls the “reckless approval of aducanumab for Alzheimer’s.” Public Citizen calls for the three to leave the agency in a 6/16 letter to HHS secretary **Xavier Becerra**.

A Public Citizen [statement](https://www.citizen.org/news/letter-acting-fda-commissioner-woodcock-other-top-officials-must-resign-following-indefensible-aducanumab-approval/?ref=fdaweb.com) (includes a link to the letter) says the agency decision to approve aducanumab for anyone with Alzheimer’s disease, regardless of severity, “showed a stunning disregard for science, eviscerated the agency’s standards for approving new drugs, and ranks as one of the most irresponsible and egregious decisions in the history of the agency. The primary beneficiaries of the agency’s action are Biogen and its shareholders, who undoubtedly are ecstatic about their soon-to-be-reaped windfall profits from sale of the company’s exorbitantly priced but ineffective drug.”

The letter says FDA’s mistakes in handling aducanumab included: 

- an unprecedented, inappropriately close collaboration between the agency and Biogen in analyzing data from the drug’s key clinical trials that “dangerously compromised the independence and objectivity of the agency’s review of the drug”;
- basing approval on an unvalidated surrogate endpoint — reduction of amyloid-beta plaques in the brain — and incorrectly claiming that such reduction is expected to lead to a reduction in the clinical decline of Alzheimer’s disease, despite abundant currently available evidence showing no correlation between changes in the endpoint and changes in clinical measures of cognitive function;
- failing to adequately integrate the “thoughtful, science-based input and recommendations of the agency’s Peripheral and Central Nervous System Drugs Advisory Committee into the approval decision and to seek additional advice from the committee before using the accelerated approval pathway; and
- approving the drug for all types of Alzheimer’s disease patients even though the safety and effectiveness of the drug were assessed in clinical trials that enrolled only patients with mild Alzheimer’s disease.

Public Citizen says it believes FDA should have rejected the drug and required Biogen to conduct another large placebo-controlled trial before giving any further consideration to approving it.

“The sheer recklessness of FDA’s approval of aducanumab cannot be overstated,” says Public Citizen Health Research Group director **Michael Carome**. “The decision is a disastrous blow to the agency’s credibility, public health, and the financial sustainability of the Medicare program.”