Billy Dunn, FDA’s top neuroscience official to depart agency

Regulatory NewsRegulatory News | 27 February 2023 |  By 

Billy Dunn (source: FDA)

The US Food and Drug Administration’s (FDA) top neuroscience official, Billy Dunn, who oversaw the controversial approval of Biogen’s Alzheimer’s disease drug Aduhelm (aducanumab-avwa), is leaving the agency after an 18-year tenure.
Dunn’s departure was announced in an internal email from Peter Stein, director of the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER), which said Dunn is retiring from the agency to pursue “other opportunities” in the neurological disease space.
“It was with regret that I announce the departure of Dr. Billy Dunn, Director of the Office of Neuroscience (ON) in OND. After a long and highly productive career in public service, Billy has decided to retire from FDA and explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases,” Stein wrote.
Stein also announced that Teresa Buracchio, who previously served as acting deputy director of the Office of Neuroscience (ON), has been made permanent deputy director of the office and will serve as office director on an acting basis.
Dunn first joined FDA’s Division of Neurological Products (DNP) in 2005 after a stint as a clinician and researcher at the National Institute of Neurological Disorders and Stroke (NINDS). He quickly advanced through the ranks as a team leader, deputy director, and director of the Division of Neurological Products before becoming the first director of the Office of Neuroscience.
“Over the years, Billy has been encouraging, facilitating, and defining neurological drug development and regulation in his leadership roles in DNP and ON. He has made a major impact in how drugs are developed for a range of serious neurological diseases—many that previously had only limited treatment options. His work and leadership contributed to major therapeutic advances in neuro-immunological diseases such as multiple sclerosis and myasthenia gravis, advances in rare neurological disorders, advances in migraine treatment, advances in the range of complex seizure disorders, advances in therapies for Alzheimer’s Disease, among many other neurological disorders,” Stein wrote.
However, it was Dunn’s involvement in the review and approval of Aduhelm in 2021 that brought on renewed criticism of the agency’s accelerated approval program and in part prompted Congress to pass some reforms to the program in the Food and Drug Omnibus Reform Act (FDORA) passed as part of the FY2023 omnibus spending bill. Dunn’s controversial actions in the approval of Aduhelm were profiled by Stat and were detailed in a joint report by the staffs of the House Committee on Oversight and Reform and the Energy and Commerce Committee.
Dunn also notably oversaw the decision to approve Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate/taurursodiol) in September 2022 after convening a rare second advisory committee meeting to review the drug after the committee initially voted against approving the drug six months prior.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you