CDER Neuroscience Director Dunn Leaving Agency
A top figure in FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm is retiring from CDER’s Office of Neuroscience (ON) — director Billy Dunn. After an 18-year career at the agency, Dunn has decided to “explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases,” according to an email shared with FDA Webview from Office of New Drugs director Peter Stein. Stein says that recently appointed ON deputy director Teresa Buracchio will serve as acting director while a search for Dunn’s replacement is undertaken.
Buracchio has a medical degree from Rush University Medical Center in Chicago. She joined FDA in 2013 as a medical reviewer in the Division of Gastroenterology and Inborn Error Products, and moved to the Division of Neurology Products (DNP) in 2014. At DNP, she worked her way up to a deputy division director in 2020, and in 2021 to a Division Director. Since 11/2022, Buracchio has been the acting ON deputy office director.
Aduhelm’s 2021 approval was met with much public concern and outrage, with many pointing to the unusual turn to accelerated approval following FDA’s 11/2020 Peripheral and Central Nervous System Drugs Advisory Committee meeting that voted down Biogen’s study data being considered for traditional approval (see earlier story). Interestingly, panel members were not asked for their input on whether accelerated approval was a viable option. Shortly after the drug’s approval and in protest of FDA’s irregularities, three of the panel members resigned (see story)
A subsequent investigation by two House committees culminated in a 12/30/2022 report that was sharply critical of the approval and the agency’s decision to work so closely with the company to guide the drug’s review and approval. The report found FDA’s interactions with Biogen were atypical and that the agency had deviated from its own guidance on documenting meetings with industry, citing Billy Dunn in many of these meetings.
FDA reviewers and Biogen staff held at least 115 meetings, calls and email exchanges over a 12-month period, and this number is likely greater because the agency lacked a “clear record” of informal meetings and other interactions between its staff and Biogen, the Oversight and Reform and Energy and Commerce Committees’ report found. It also found that FDA and Biogen “inappropriately collaborated on a joint briefing document” for an advisory committee review, and the document failed to adequately represent differing views within the agency.
The report also noted that an FDA internal review of the briefing document collaboration found that CDER’s Office of Neuroscience had failed to obtain Office of New Drugs consensus on the agency’s position prior to working with Biogen on the document. The internal review concluded that “the use of the joint briefing document was not an appropriate approach in this instance” given the substantial disagreement between FDA offices. The internal review was sparked by a complaint from advocacy group Public Citizen that warned the close collaboration “dangerously compromised the integrity of FDA’s review.”