As the Race for a Permanent FDA Commissioner Picks Up, Agency Turnover Continues

Regulatory NewsRegulatory News | 04 September 2019 |  By 

With a decision on a permanent US Food and Drug Administration (FDA) Commissioner slated for the end of October at the latest, the steady stream of FDA employee defections to industry continues.

So, who will be nominated as the next commissioner?

Some influential health groups and former FDA commissioners (including Scott Gottlieb), according to the Washington Post, are pushing for Acting Commissioner Ned Sharpless to be nominated, while the Wall Street Journal in June reported that contenders include Alexa Boer Kimball, chief executive of the Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, and a doctor at the M.D. Anderson Cancer Center in Houston. And BioCentury reported last week that assistant secretary of health Brett Giroir is also in the running.

As the rumors continue to swirl, several high-profile FDA employees have departed in recent months. And as part of the most recent iteration of the prescription drug user fee program, FDA’s Center for Drug Evaluation and Research (CDER) has only made 32 new hires in FY 2019, with a goal to hire to 20 more. FDA’s Center for Biologics Evaluation and Research has onboarded all eight of its planned hires.

As for the departures, Ed Cox, former director of FDA’s Office of Antimicrobial Products, recently left FDA to take a position as regulatory affairs VP at Regeneron Pharmaceuticals. An FDA spokesman told Focus that John Farley will serve as the acting office director for OAP.

Kathleen Quinn, who served as a senior advisor to the commissioner for more than seven years at FDA, also began work as head of corporate communications at GlaxoSmithKline this month.

Lauren Silvis, former chief of staff to FDA Commissioner Scott Gottlieb, joined technology company Tempus as its SVP of external affairs.

And former FDA Principal Deputy Commissioner Rachel Sherman, who retired in January, this month joined the Board of Directors of Aptinyx, a clinical-stage biopharmaceutical company.

In addition, Felix Frueh, who formerly served as the associate director for genomics in CDER, joined NDA Partners as an expert consultant on Wednesday.


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