Skip to main content

Sign up for our newsletter.

Quality journalism. Progressive values. Direct to your inbox.

For Immediate Release

Press Release

Letter: Acting FDA Commissioner Woodcock, Other Top Officials Must Resign Following Indefensible Aducanumab Approval

Agency inappropriately collaborated with Biogen, approved unproven Alzheimer’s treatment
WASHINGTON -

Top U.S. Food and Drug Administration (FDA) officials responsible for the reckless approval of aducanumab for Alzheimer’s, including Acting Commissioner Janet Woodcock, should immediately resign, Public Citizen said in a letter to U.S. Department of Health and Human Services Secretary Xavier Becerra.

Last week, the FDA announced its approval of aducanumab for treatment of Alzheimer’s disease despite the nearly unanimous conclusion of an independent advisory panel of experts that there was insufficient evidence that the drug was effective and following an inappropriate and unprecedented collaboration between the agency and Biogen during the data analysis stage of key clinical trials.

Public Citizen contends that the FDA should have rejected the drug and required that the company conduct another large, placebo-controlled clinical trial before giving any further consideration to approving aducanumab to treat Alzheimer’s disease. Approving aducanumab despite the lack of evidence of effectiveness has raised false hope for millions of Alzheimer’s disease patients and threatens to bankrupt the Medicare program because of the drug’s exorbitant price ($56,000 per year).

Public Citizen’s letter urged Becerra to request the resignations of, or seek the removal of, the three officials most responsible for the decision: Woodcock, Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni and CDER’s Office of Neuroscience (ON) Director Billy Dunn.

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

###

Public Citizen full logo

Public Citizen is a nonprofit consumer advocacy organization that champions the public interest in the halls of power. We defend democracy, resist corporate power and work to ensure that government works for the people – not for big corporations. Founded in 1971, we now have 500,000 members and supporters throughout the country.

Washington County's New Rules Against Fossil Fuel Expansion Celebrated as 'Blueprint' for Nation

"This is a landmark victory for the local communities who have stood up and held firm for over a decade to protect the climate, the Salish Sea, and their own health and safety."

Jessica Corbett ·


Pelosi Under Fire for Parroting 'Right-Wing Lies' Against Student Loan Debt Cancellation

"The truth is Biden can cancel 100% of your federal student loans with a signature."

Jake Johnson ·


FCC Cheered for Cleaning Up After Pai Awarded Contracts to Connect 'Empty Parking Lots'

"Ajit Pai ignored early criticism and rapidly awarded money to the likes of Elon Musk for building broadband bridges to nobody."

Andrea Germanos ·


Planet's Vital Signs Are Reaching Dangerous 'Tipping Points' Amid Climate Crisis, Scientists Warn

"We need to stop treating the climate emergency as a stand-alone issue—global heating is not the sole symptom of our stressed Earth system."

Julia Conley ·


Physicians Group Documents 'Severe' Health and Human Rights Impacts of US Expulsion Policy

"With each passing day, the Biden administration is trampling on its professed commitment to science-based policymaking and a humane immigration system."

Jake Johnson ·