Billy Dunn Steps Down from Post as FDA Neuroscience Head

FDA_Al Drago/CQ Roll Call

Courtesy of Al Drago/CQ Roll Call

Billy Dunn, the FDA's controversial neuroscience head, is stepping down from his post to "explore other opportunities," according to an internal FDA e-mail.

Dunn told the FDA Friday of his plans to retire, according to an unnamed source, STAT News reported Monday. Dunn served at the FDA for nearly 18 years, joining the Office of Neurological Products in 2005.

Effective immediately, Teresa Buracchio, current deputy director of the Office of Neuroscience, will assume the director role in an acting fashion, according to the e-mail from Peter Stein, head of the FDA's Office of New Drugs. 

"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 in part. 

The controversy surrounding the embattled Dunn stems from the FDA's decision to approve Biogen and Eisai's Alzheimer's drug, Aduhelm, over the overwhelming dissent of its Peripheral and Central Nervous System Drugs Advisory Committee.

The FDA approved Aduhelm in June 2021 as the first drug to treat Alzheimer's in 18 years. Dunn's allegedly close ties to Biogen were reported at the time.  

When the partners' second Alzheimer's drug, Leqembi (lecanemab), won accelerated approval in January 2023, it wasn't considered nearly as controversial – possibly because of more significant evidence of amyloid clearance.

Eisai and Biogen also submitted for full traditional approval of Leqembi the next day. Eisai anticipates full approval will be granted as early as summer 2023.

With the era of Dunn coming to a close, either Buracchio or another successor will be responsible for deciding whether to grant traditional approval to Eli Lilly's donanemab. The drug failed to win an accelerated nod in January.

The Office of Neuroscience will be busy in 2023. Critical upcoming decisions include Biogen's tofersen for superoxide dismutase 1 (SOD1) ALS, which faces an adcomm meeting in March ahead of an April 25 PDUFA date. Acadia Pharmaceuticals has a review date of March 12 for trofinetide as a treatment for Rett syndrome.

Amidst the divisional upheaval, Reata Pharmaceuticals expects a decision on Feb. 28 on omaveloxolone, which, if approved, would be the first treatment for Friedreich's ataxia. 

Reata's stock fell 34% in the wake of Dunn's departure, with a pending approval on the docket. 

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