FDA Official Who Oversaw Aducanumab Approval Retiring

Alicia Ault

March 03, 2023

A US Food and Drug Administration (FDA) official who oversaw the approval of the controversial Alzheimer's therapy aducanumab (Aduhelm) is retiring from the agency to 'explore other opportunities.'

The retirement of Billy Dunn, MD, director of the Center for Drug Evaluation and Research's Office of Neuroscience, was reportedly announced in an internal memo to FDA staff.

Dunn, 53, joined the FDA in 2005 and eventually became the first director of the Office of Neuroscience. The official has been enmeshed in controversy for several years.

In June 2021, as reported by Medscape Medical News, Public Citizen's Health Research Group called for the removal of Dunn and two other FDA officials: Janet Woodcock, MD (Acting FDA Commissioner at the time) and Patrizia Cavazzoni, MD, director of CDER.

The consumer advocacy group said that the approval of aducanumab was "reckless," and "ranks as one of the most irresponsible and egregious decisions in the history of the agency."

The aducanumab approval was also criticized by eight past and current members of the FDA's Peripheral and Central Nervous System Drugs Advisory Committee in an August 2021 editorial in the New England Journal of Medicine. Dunn and Cavazzoni and several other FDA colleagues defended the approval in the same journal, calling it an appropriate use of accelerated approval.

In August 2021, the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) opened an investigation into the agency's use of accelerated approval, including for aducanumab.

"The FDA's approval of Aduhelm raised concerns due to alleged scientific disputes within the FDA, the advisory committee's vote against approval, allegations of an inappropriately close relationship between the FDA and the industry, and the FDA's use of the accelerated approval pathway," OIG said in its description of the project. It will complete its inquiry in 2024.

Dunn oversaw several other controversial or troubled approvals, supporting for instance, the marketing of AMX0035 (Relyvrio) for amyotrophic lateral sclerosis, which was granted a second advisory committee meeting after failing in the first.

The neurology chief also supported two Duchenne muscular dystrophy therapies developed by Sarepta: Exondys 51 and Vyondys 53. When Vyondys 53 was approved in 2019, Sarepta thanked Dunn in its press release.

Dunn has other admirers, including the Global Alzheimer's Platform Foundation, a nonprofit supported by industry partners including Biogen, Eisai, Takeda, Lilly, and Roche.

"We want to thank and honor Dr. Billy Dunn for his leadership and scientific contributions," said GAP Foundation President John Dwyer in a statement

"His service at the US Food and Drug Administration, his leadership as the head of the FDA's neuroscience office and his strategic insights into how to move drugs forward — while safeguarding the patients who take them — is unparalleled," said Dwyer.

Teresa Buracchio, MD, current director of the FDA's Division of Neurology 1, has been named to take over for Dunn on an interim basis. Buracchio first joined the agency after she left AbbVie in 2013. She moved to the Division of Neurology Products in 2014 and has worked as a clinical reviewer and team leader for Alzheimer's disease and dementia, epilepsy, and neuromuscular and rare diseases.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in publications including JAMA and Smithsonian.com. You can find her on Twitter @aliciaault.

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