Robert Califf Leaving Post as FDA Commissioner

Robert Califf, MD, will be stepping down as commissioner of the US Food and Drug Administration (FDA) on January 20, the day of incoming President Donald Trump’s inauguration.

The move was confirmed by FDA spokesperson Jennifer Rodriguez, who said in an email to TCTMD that Califf will leave at noon on that day “as per the traditional presidential transition process.”

Califf, the cardiologist and prominent clinical researcher who was founding director of the Duke Clinical Research Institute (Durham, NC), was confirmed as commissioner in February 2016 after a nomination process that saw opposition from several lawmakers, including Sen. Bernie Sanders (I-VT), who questioned his ties to industry and commitment to lowering drug costs. Califf had served as the deputy commissioner of the agency’s Office of Medical Products and Tobacco since February 2015.

Rodriguez would not confirm that Califf will be replaced on an interim basis by Stephen Ostroff, MD, who is deputy commissioner for foods and veterinary medicine and who served as acting commissioner before Califf was confirmed. Whoever holds the position Ostroff currently occupies is in line to act as commissioner unless that person “does not meet the requirements of the Vacancies Reform Act or the President has directed someone else to act as Commissioner,” according to FDA policy pointed out by Rodriguez.

Politico reports that the leading candidate to replace Califf on a more permanent basis is venture capitalist Scott Gottlieb, a former FDA deputy commissioner.

According to the Wall Street Journal, Trump also had meetings scheduled with two Silicon Valley investors being considered for the job: Jim O’Neill, managing director of Mithril Capital Management, who has previously worked in the US Department of Health & Human Services under President George W. Bush, and Balaji Srinivasan, founder of the genetic-counseling firm Counsyl.