FDA NewsPerspective

Califf stepping down as FDA commissioner

Robert M. Califf, MD, MACC, is stepping down as FDA commissioner effective Friday, Jan. 20, the day of President-elect Donald J. Trump’s inauguration.

“Commissioner Califf’s last day will be Jan. 20, 2017, at noon, as per the traditional presidential transition process,” FDA spokeswoman Jennifer Rodriguez told Cardiology Today and Cardiology Today’s Intervention.

Califf, a cardiologist, was named FDA commissioner in February 2016, replacing Margaret A. Hamburg, MD. He joined the agency in January 2015 as deputy commissioner for medical products and tobacco.

Robert M. Califf, MD
Robert M. Califf

An acting commissioner will be named shortly, but further information is not available at this time, Rodriguez said.

According to the Federal Vacancies Reform Act of 1998, if the FDA commissioner position is vacated, the deputy commissioner for foods and veterinary medicine shall 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 pursuant to the Vacancies Reform Act.”

The current deputy commissioner for foods and veterinary medicine is Stephen Ostroff, MD, who served as acting FDA commissioner between Hamburg’s resignation and Califf’s confirmation.

Before joining the FDA, Califf served as vice chancellor of clinical and translational research at Duke University, director of the Duke Translational Medicine Institute, professor of medicine in the division of cardiology at the Duke University Medical Center and founding director of the Duke Clinical Research Institute. When he joined the FDA, Califf was one of the top 10 most-cited medical authors according to the Institute for Scientific Information, with more than 1,200 peer-reviewed publications. – by Erik Swain

 

 

Robert M. Califf, MD, MACC, is stepping down as FDA commissioner effective Friday, Jan. 20, the day of President-elect Donald J. Trump’s inauguration.

“Commissioner Califf’s last day will be Jan. 20, 2017, at noon, as per the traditional presidential transition process,” FDA spokeswoman Jennifer Rodriguez told Cardiology Today and Cardiology Today’s Intervention.

Califf, a cardiologist, was named FDA commissioner in February 2016, replacing Margaret A. Hamburg, MD. He joined the agency in January 2015 as deputy commissioner for medical products and tobacco.

Robert M. Califf, MD
Robert M. Califf

An acting commissioner will be named shortly, but further information is not available at this time, Rodriguez said.

According to the Federal Vacancies Reform Act of 1998, if the FDA commissioner position is vacated, the deputy commissioner for foods and veterinary medicine shall 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 pursuant to the Vacancies Reform Act.”

The current deputy commissioner for foods and veterinary medicine is Stephen Ostroff, MD, who served as acting FDA commissioner between Hamburg’s resignation and Califf’s confirmation.

Before joining the FDA, Califf served as vice chancellor of clinical and translational research at Duke University, director of the Duke Translational Medicine Institute, professor of medicine in the division of cardiology at the Duke University Medical Center and founding director of the Duke Clinical Research Institute. When he joined the FDA, Califf was one of the top 10 most-cited medical authors according to the Institute for Scientific Information, with more than 1,200 peer-reviewed publications. – by Erik Swain

 

 

    Perspective
    Douglas L. Mann

    Douglas L. Mann

    I personally am disappointed that Dr. Califf’s departure. I know that many of my colleagues feel similarly. It is premature to speculate on the implications of Dr. Califf’s departure for translational research and for medicine in general. The answer to this question will depend on who is picked as Dr. Califf’s permanent replacement.

    It would be hard to point to one particular thing that distinguished Dr. Califf’s relatively short tenure as commissioner of the FDA. What does distinguish his tenure as FDA commissioner is that he made significant progress in a number of different areas, including the evaluation of devices, food safety, opioids and tobacco regulation. He promoted innovation and helped to revitalize the FDA workforce. He also made important strides in standardizing the platforms used for genetic testing, which will be critical for the Precision Medicine Initiative. Dr. Califf was also masterful at communicating these efforts to the public. 

    As a “translationalist,” I hope that the new FDA commissioner prioritizes speedier drug and device approvals without sacrificing science-based decision making. As a physician, I hope the new commissioner will prioritize maintaining a robust generic pipeline to keep health care costs down and also deal with the opioid crisis facing our nation. As an American, I hope that the new commissioner focuses on modernizing the food safety system, so that my family is safe.

    • Douglas L. Mann, MD, FACC
    • Cardiology Today Editorial Board Member Washington University School of Medicine, St. Louis

    Disclosures: Mann reports consulting for Bristol-Myers Squibb and Novartis, serving on an advisory board for Miragen Therapeutics and serving on the Data Safety Monitoring Board for a clinical trial sponsored by Impulse Dynamics.