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# Prothena Adds Ex-FDA Neuroscience Head to Board
- URL: https://www.fdaweb.com/prothena-adds-ex-fda-neuroscience-head-to-board/
- Published: 2023-05-17T12:00:00.000Z
- Updated: 2026-09-14T18:32:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154478

Prothena says it has appointed former CDER Office of Neuroscience director **Billy Dunn** to its board of directors. The company is a self-described “late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise.”

Dunn was a top figure in FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm. He left CDER in February after an 18-year career at the agency. Aduhelm’s 2021 review status was controversially switched from traditional to accelerated approval after FDA’s 11/2020 Peripheral and Central Nervous System Drugs Advisory Committee meeting voted down Biogen’s study data ([see earlier story](https://www.fdaweb.com/panel-thumbs-down-on-biogen-alzheimers-drug/)). Significantly, panel members were not asked for their input on whether accelerated approval was a viable option. Shortly after the drug’s approval, three of them resigned in protest ([see story](https://www.fdaweb.com/harvards-kesselheim-is-3rd-fda-advisor-to-resign/)).

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](https://oversightdemocrats.house.gov/sites/democrats.oversight.house.gov/files/2022-12-29.COR%20%26%20E%26C%20Joint%20Staff%20Report%20re.%20Aduhelm.pdf?ref=fdaweb.com) 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.

The report 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. Additionally, it 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](https://www.fdaweb.com/probe-fda-biogen-alzheimers-drug-collaboration-public-citizen/) from advocacy group Public Citizen that warned the close collaboration “dangerously compromised the integrity of FDA’s review.”