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Obama to nominate Dr Robert Califf as FDA commissioner

Thecardiologist is the frontrunner to replace Margaret Hamburg

FDA Dr Robert CaliffEminent cardiologist Dr Robert Califf has been confirmed as President Obama's preferred choice for commissioner of the FDA, according to the White House.

Formerly a professor of medicine at Duke University, Califf joined the FDA in January as deputy commissioner for medical products and tobacco, shortly before former FDA Commissioner Margaret Hamburg announced her resignation from the post in March.

Since then the agency has been led by acting commissioner Stephen Ostroff, but from that time Califf has been widely tipped to take over the running of the FDA on a permanent basis, having been in the running for the role when Hamburg was appointed six years ago.

The president's nomination has to be confirmed by a vote in the Senate, but Califf is thought to be a popular choice and is not expected to face much opposition. 

He may however face questioning over links to industry, having disclosed considerable consulting fees and research funding from pharma companies - including just about all the top 10 drug firms - before joining the agency. 

Other names mentioned in connection with the post in recent months include Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), cardiologist Steve Nissen of the Cleveland Clinic and Susan Wood, director of the Jacobs Institute of Women's Health.

Before joining the FDA, Califf had the role of vice chancellor of clinical and translational research at Duke University, having previously led the Duke Translational Medicine Institute (DTMI) and helped to set up Duke Clinical Research Institute.

His links with the agency go back many years, as he has also served as a member of the FDA Cardio-renal Advisory Panel and FDA Science Board's Subcommittee on Science and Technology.

That experience could serve the agency well as it faces the possibility of considerable changes to its activities under the House of Representatives' proposed 21st Century Cures Act, which, among other initiatives, includes a drive towards a streamlined approval process for new medicines and greater acceptance of new clinical trial designs.

A similar bill is being considered in the Senate and the two will have to be brought into alignment and secure a presidential signature for the new legislation to come into effect. 

There does seem to be an appetite among lawmakers from both houses for FDA reforms, however, and the new commissioner will likely have to take the helm at a time of considerable change for the agency.

Article by
Phil Taylor

16th September 2015

From: Regulatory

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