A Duke researcher was nominated as the next commissioner of the Food and Drug Administration by President Barack Obama Tuesday.
Dr. Robert Califf, former vice chancellor for clinical and translational research, was appointed deputy commissioner for Medical Products and Tobacco at the FDA in January and will now await Senate approval for the commissioner position after being nominated. Califf—who has taken a leave of absence from the University due to his FDA duties—is a renowned cardiologist and the founding director of the world’s largest academic research organization, the Duke Clinical Research Institute. Bloomberg reported Tuesday that the nomination came in a statement that included the names of nominees for several administrative positions.
If confirmed, Califf will replace Stephen Ostroff, who has served as acting commissioner since former commissioner Margaret Hamburg left the position in March. One of the challenges Califf could face is adjusting to the new parameters for faster drug and medical device approval outlined in the 21st Century Cures Act, which would provide $550 million to the FDA in the next five years and is awaiting Senate approval.
When Califf spoke to The Chronicle in January after being tapped as deputy commissioner for Medical Products and Tobacco, he noted that he hoped to address the increase in electronic health records and improve the FDA’s clinical trial process. The Bloomberg article announcing Tuesday’s nomination noted that Califf, 63, has more than 1,200 publications in peer-reviewed literature and has been instrumental in several drug-related clinical trials.
“My particular career specialty has been clinical trial design and efficiency,” he previously told The Chronicle. “There’s huge support everywhere now to streamline clinical trials. Making studies better—what could be more interesting?”