FDA Commissioner Califf Stepping Down on January 20

Alicia Ault

January 19, 2017

US Food and Drug Administration (FDA) Commissioner Robert Califf, MD, will be stepping down from his position shortly after Donald Trump takes the oath of office to become the 45th president of the United States tomorrow.

"His last day will be January 20, 2017, at noon, as per the traditional presidential transition process," FDA spokeswoman Jennifer Rodriguez told Medscape Medical News.

It has been a short run for the former Duke University cardiologist, who became commissioner in February 2016, some 5 months after he was first nominated by President Barack Obama.

The commissioner's post had been open since March 2015, when Margaret Hamburg, MD, stepped down after a 6-year stint. Stephen Ostroff, MD, the FDA deputy commissioner for foods and veterinary medicine, served as acting commissioner until Dr Califf took over.

Dr Ostroff will likely step into that role again, at least temporarily. According to the Federal Vacancies Reform Act of 1998, the first person in line to take over if the commissioner's position becomes open is the deputy commissioner for foods and veterinary medicine.

A few names have been floated for FDA commissioner under a Trump administration, but Dr Califf's was not mentioned. One that has surfaced on a regular basis: Scott Gottlieb, MD, who has been advising the Trump transition as a member of the "HHS Landing Team."

Currently a resident scholar at the American Enterprise Institute, Dr Gottlieb served as a deputy commissioner for medical and scientific affairs at the FDA and a senior policy adviser to the administrator at the Centers for Medicare & Medicaid Services — both in the George W. Bush administration.

Before joining the FDA, Dr Califf was vice chancellor of clinical and translational research at Duke University and director of the Duke Translational Medicine Institute, a professor at Duke University School of Medicine, and the cofounder of the Duke Clinical Research Institute.

Although he had the backing of many physician organizations, he was also assailed by various critics — including Sen. Joe Manchin (D-WVa) and Sen. Bernie Sanders (I-Vt) — who said he was too closely tied to the pharmaceutical industry.

Dr Gottlieb has conflicts as well. He advises many drug and biotechnology companies, including GlaxoSmithKline and Vertex Pharmaceuticals. He's also on the board of directors for Tolero Pharmaceuticals and is the managing director of T. R. Winston & Co, a privately held bank with a focus on healthcare.

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