UPDATE: Obama nominates Robert Califf as next FDA commissioner
- President Barack Obama has nominated Dr. Robert Califf to be the next Commissioner of the FDA, according to a press release from the White House.
- Califf has been serving as the Deputy Commissioner for Medical Products and Tobacco at the FDA since his direct appointment to the position by former Commissioner Margaret Hamburg in January. Hamburg stepped down as commissioner at the end of March after nearly six years on the job—one of the longest contemporary tenures for an FDA commissioner. FDA scientist Dr. Stephen Ostroff has been serving as the interim commissioner since Hamburg's departure.
- Califf was the Vice Chancellor of Duke University's School of Medicine and a professor of cardiology and medicine at the school before his appointment to the FDA deputy commissioner position.
As it turns out, the rumor mills—which began churning the moment that Califf was appointed by Hamburg—were correct.
Califf's medical credentials are unquestionable. Beyond his experience as a professor of medicine and extensive past work running clinical trials, Califf has also worked closely with the pharmaceutical industry and encouraged greater cooperation between patient groups, governments, and the biopharma sector.
During his tenure at the FDA, Califf has been responsible for providing executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Tobacco Products. He's also had to oversee major initiatives involving hot topic issues such as personalized/precision medicine, orphan drugs, and more.
Califf is being nominated to the top spot at the FDA during a time of critical change. The agency has been pursuing far more aggressive steps to approve orphan drugs and treatments for patients with unmet medical needs, on top of implementing important overhauls to the food safety system.
Congress is in the process of advancing a major FDA reform bill intended to further expedite drug development; involve patient voices in the regulatory process; make it easier for the industry to communicate the economic value of drugs; and introduce many other changes. The bill, dubbed the 21st Century Cures Act, overwhelmingly passed the House of Representatives on a bipartisan basis in July and is expected to receive a vote in the Senate this fall.