Billy Dunn is leaving his post leading the FDA’s neuroscience team after an 18-year career that in recent years has included the controversial accelerated approval of Biogen’s Alzheimer’s med Aduhelm.
The embattled regulator—who has been accused of having a too-cozy relationship with Biogen prior to the approval of that drug—is leaving to “explore other opportunities” according to an email sent today from Peter Stein, head of the Office of New Drugs, to colleagues. The departure ends 18 years at the agency for Dunn, after joining the Office of Neurological Products in 2005. He worked his way up the division and ultimately helped create and lead the Office of Neuroscience.
Dunn’s departure comes just more than a year after deputy director of the office, Eric Bastings, left to take an executive role at Ionis Pharmaceuticals. Taking both of their places will be Teresa Buracchio, M.D., who Stein said in a separate email was tapped to be the new deputy director. She will also be the interim head of the neuroscience team until a permanent replacement is named.
In one of his emails to staff, Stein praised Dunn’s work overseeing development in the field.
“He has provided thoughtful direction for individual [investigative new drug] development programs and has also moved the field more broadly through innovations in trial designs and endpoints, clarifying how drugs targeting particular disorders can be more efficiently developed,” Stein wrote.
But a congressional report released at the end of 2022 detailed a relationship described as “inappropriate” and “atypical” between Biogen and regulators leading up to the accelerated approval of Aduhelm. Among the details in the report was that the FDA and Biogen worked together on the company’s briefing documents ahead of critical meetings with FDA advisers. Some portions of Biogen’s documents were drafted by the FDA. Commissioner Robert Califf, M.D., called the report “inflammatory.”
That report came a year and a half after Stat News uncovered back-channel dealings between the agency and Biogen. At the center of those conversations was Dunn, who at least one insider described as an ally of Biogen’s efforts. The report disclosed an off-the-books meeting between Dunn and then-Biogen Chief Scientific Officer Al Sandrock at a neurology conference in Philadelphia that may have run counter to FDA policy.
The FDA’s neuroscience team has been involved in a number of high-profile regulatory decisions of late, beyond just Aduhelm. Eisai’s Leqembi recently nabbed accelerated approval to treat Alzheimer’s and Amylyx convinced regulators its amyotrophic lateral sclerosis (ALS) drug deserved the green light after a rare second meeting with FDA advisers. The FDA also recently declined to grant accelerated approval of Eli Lilly’s Alzheimer’s candidate donanemab, punting until the company produces phase 3 data and submits for full approval.