Pictured: FDA Building/courtesy of Grandbrothers/Adobe Stock
Former FDA Neuroscience Director Billy Dunn made waves when Biogen’s Aduhelm (aducanumab) was approved on his watch, and last week, he made headlines again by joining the board of Prothena, reigniting the debate over the so-called revolving door between the FDA and industry.
Dunn stepped down from his role as director of the Office of Neuroscience in February to “explore other opportunities,” according to an internal FDA email.
During his tenure at the FDA, Dunn fashioned himself as a champion of the patient, advocating for regulatory flexibility with the approval of Amylyx’s ALS drug Relyvrio—after not one but two advisory committee meetings—and with initiatives like the FDA’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS), announced in June 2022.
In a press release announcing his appointment to Prothena’s board, Dunn hailed the neuroscience-focused company’s “commitment to patient-focused drug development,” calling it a patient-first approach he strongly supports.
“Dr. Dunn and Prothena share a deep commitment to advancing novel and next-generation medicines for neurodegenerative and rare peripheral amyloid diseases,” Michael Bachner, senior director, corporate communications at Prothena, told BioSpace in an email.
While Prothena has a Phase III program for amyloid light-chain (AL) amyloidosis, analysts primarily focused on a Phase I anti-amyloid-beta antibody for Alzheimer’s disease, PRX012, in relation to Dunn’s appointment.
“Billy Dunn’s career leadership at the FDA neuroscience division should help guide development and regulatory strategy for [Prothena] as they advance PRX012 through the clinic,” Michael Yee, managing director at Jefferies, wrote in a May 16 note sent to BioSpace. Dunn’s interest in Prothena speaks to the quality of Prothena’s data and “relationships” the company’s management have with regulators, Yee wrote.
FDA Officials Exit to Industry
Dunn is just the latest ex-FDA official to make the jump to industry. In 2019, former FDA commissioner Scott Gottlieb joined the board of Pfizer, and in March 2022, ex-FDA vaccine official Philip Krause signed on to advise Mesoblast, a biotech developing allogeneic cellular therapies for conditions like graft versus host disease and inflammatory bowel disease.
Just how often FDA employees go on to join biopharmaceutical companies was demonstrated in a 2016 article published in the journal BMJ, which found that more than half of the hematology-oncology assessors who reviewed drugs between 2001 and 2010 later worked in the industry.
“I think it’s astonishingly high,” the paper’s senior author, Vinay Prasad, currently a professor of epidemiology and biostatistics at UCSF, told STAT News at the time. He questioned whether reviewers’ assessments might be affected if they are looking to land a position in industry, according to STAT.
Daniel McIntyre, former head of corporate affairs at Biogen and current biopharma public affairs consultant, told BioSpace that while the optics of former FDA officials taking company positions are dicey, they aren’t categorically improper, “especially on boards, which are primarily advisory roles.”
Genevieve Kanter, associate professor of public policy at the University of Southern California Price School of Public Policy, agreed that people moving from government to industry and vice-versa “is not necessarily problematic.”
However, Kanter said one potential issue is regulatory capture, “where regulatory agencies are unduly influenced by the industries that they regulate.” She added that it is important to look at the exit or entry conditions as it pertains to specific individuals.
In the case of Dunn’s board role at Prothena, Kanter pointed to PRX012, which is in the early stages of FDA review and was granted Fast Track designation in April 2022. “Typically, if a person is looking to leave, they have to recuse themselves from any activity related to where they might lead,” she said. However, she added that it is not clear Dunn had been planning to go to Prothena “because there are other circumstances related to aducanumab which may have led him to exit.” As such, he may have played a role in PRX012’s review, though this is not clear.
An FDA representative told BioSpace in an email that the regulator “takes seriously its obligation to help ensure that decisions made, and actions taken, by the agency and its employees, are not, nor appear to be, tainted by any question of conflict of interest.
“The FDA’s Office of Ethics and Integrity provides robust ethics guidance to the employee and/or his or her supervisor to ensure the employee appropriately disqualifies himself or herself from job duties in compliance with the ethics laws during the time he or she is seeking employment with a non-Federal entity,” the representative said.
Peter Pitts is a former associate commissioner for external relations at the FDA and current president and co-founder of the Center for Medicine in the Public Interest. He told BioSpace that Dunn “would never divulge commercial, confidential FDA information” and that he would not contact or work with the FDA on Prothena’s behalf.
This safeguard is outlined in a Post-Employment Restrictions document, which states in part that former FDA employees are “prohibited from making a communication to or appearance before the Government on behalf of [their] new employer or anyone else regarding a ‘particular matter involving specific parties’ in which [they] participated personally and substantially.” Pitts said he is “sure that those rules are scrupulously followed.”
In the reverse situations, where individuals move from industry to the FDA, Kanter said one concern is that they might have a pro-industry bias. She called Gottlieb, who before being tapped as the agency’s 23rd commissioner served as a consultant to multiple biopharma companies including Novo Nordisk, GSK and Daiichi Sankyo, a “counter example” to this concern. “I think people were skeptical when he came in. . . . Throughout his tenure, I think many people were also impressed by his balance,” she said.
Ultimately, “exiting to industry does not have to be problematic if the kinds of information flows that are happening are really related to a better understanding what the agency is looking for in terms of approval,” Kanter said.
McIntyre agreed. “The FDA needs to attract professionals whose employment there won’t make them unemployable when they leave,” he said. “The key is disclosure and behavior, and as long as those are above board, tapping their expertise can work to the benefit of patients waiting for treatments that companies develop and the FDA regulates.”
Prothena’s Bachner declined to say whether Dunn’s advisory position would give the company an advantage in the Alzheimer’s, ALS and amyloidosis markets.
Heather McKenzie is a senior editor at BioSpace, focusing on neuroscience, oncology and gene therapy. You can reach her at firstname.lastname@example.org. Follow her on LinkedIn and Twitter @chicat08.
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