People, Pharma

Revolving door between industry and FDA continues to spin

It’s well known that leaving the FDA for industry can bring a major salary bump, so it should come as no surprise that the number of FDA employees making the leap in 2018 continues to increase.

Biotech company Moderna announced Wednesday that Wellington Sun, former director of the Division of Vaccines and Related Product Applications at FDA’s Center for Biologics Evaluation and Research, will be their new head of vaccine strategy and regulatory affairs.

Last month, Patrick Frey, chief of staff at the FDA’s Office of New Drugs (OND), left to join Amgen as director of global regulatory policy.

And former OND director John Jenkins was appointed in June to the board of directors of Corbus Pharmaceuticals. Also in June, Elaine Morefield, former deputy office director for review and administration at FDA, was appointed director of product quality at Aclaris Therapeutics, while Gerald Masoudi, former FDA chief counsel, was appointed chief legal officer at Juul Labs.

That news follows the departure of Gayarti Rao, former director of the FDA’s Office of Orphan Products Development, who moved over to Rocket Pharmaceuticals in May.

Meanwhile, 20-year FDA veteran Badrul Chowdhury, most recently director of the Center for Drug Evaluation and Research’s (CDER) Division of Pulmonary, Allergy and Rheumatology Products, took a job in April as senior vice president at AstraZeneca.

Sarah Pope Miksinski, former director of the Office of New Drug Products in the FDA’s Office of Pharmaceutical Quality, left the agency in February, also for AstraZeneca. And in July 2017, Geoffrey Kim, former director of the FDA’s Division of Oncology Products, moved to AstraZeneca to become its VP of oncology and head of oncology strategic combinations.

Jean-Marc Guettier, former director of the FDA’s Division of Metabolism and Endocrinology Products, left FDA in December 2017 for Sanofi, while Niraj Mehta, former associate director for global regulatory policy at the FDA, moved over to Merck as a director in March 2018 and Thomas Cosgrove, former director of FDA’s Office of Manufacturing Quality in the Office of Compliance, left in November 2017 to join the law firm Covington & Burling.

Questions have been raised in recent years on the revolving door between industry and FDA, particularly as experience at the agency can lead to lucrative salaries and create conflicts where relationships between industry and FDA are already cozy.

But even former FDA commissioners are getting in on the industry action. Frank Young, FDA commissioner in the 1980s, was appointed in May as executive vice president of regulatory affairs at TissueTech, while Mark McClellan, FDA commissioner from 2002 to 2004, was appointed to Cigna’s board of directors in July.

FDA did not respond to a request for comment on whether there might be others who have left the agency and gone to work in industry.

First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email for more information. 

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Recursion Pharmaceuticals Salt Lake City, UT
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