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Public Citizen demands FDA resignations after aducanumab approval 

By Brian Buntz | June 16, 2021

Public CitizenThe nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” over FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

The Alzheimer’s Association had backed the FDA approval, but many experts had concluded there was insufficient evidence to merit even conditional approval of the drug. Three members of an FDA advisory committee who had recommended against aducanumab’s approval recently resigned.

William B. Schultz, an attorney who served as a deputy commission for policy at FDA in the 1990s, said the Alzheimer’s drug approval could play a role in causing “a potential change in the standard for approving drugs that is the most significant change since Congress adopted the efficacy standard in 1962.”

In its letter, Public Citizen concluded there was an inappropriate level of collaboration between FDA and Biogen in their analysis of clinical trial data. In 2019, Biogen and its partner Eisai (OTCMKTS:ESALY) had decided to discontinue two Phase 3 trials for aducanumab known as EMERGE and ENGAGE. The company later determined that data from the trials warranted regulatory approval.

Public Citizen also took issue with the use of an unvalidated surrogate endpoint in the trial, which involved the reduction of amyloid-beta plaques. While such plaques are a hallmark of Alzheimer’s disease, there is mixed evidence for the so-called “amyloid hypothesis,” which assumes that such plaques result in clinical deterioration. Some older adults with normal cognitive function have such plaques.

Becerra has not made substantial remarks regarding the aducanumab approval, but told Politico that the FDA is “entitled to a great deal of deference and independence in the way that it acts,” and that “all of us are looking to hear just how the FDA operates based on the science.”


Filed Under: clinical trials, Drug Discovery, Neurological Disease
Tagged With: Aducanumab, Aduhelm, Alzheimer's disease, amyloid-beta plaque, Billy Dunn, Janet Woodcock, Patrizia Cavazzoni, Public Citizen, Xavier Becerra
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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