Dr. Robert Califf, a cardiologist and clinical researcher long affiliated with Duke University, on Tuesday was nominated as FDA commissioner by President Barack Obama. On Wednesday, his nomination was sent to the Senate, where it’s unlikely he will face any significant opposition for confirmation.
If confirmed, Califf will take over from Stephen Ostroff, the FDA’s chief scientist who served as acting commissioner since earlier this year upon the resignation of Margaret Hamburg.
Califf, 63, has a distinguished academic career, mostly at Duke University from 1982 through 2015, where he served as director of the university’s cardiac care unit. He also founded Duke’s clinical research institute in 2006. Along with his tenure at Duke, Califf has been involved with numerous professional organizations, including committees of the Institute of Medicine of the National Academies.
Congress has been exerting pressure on the FDA, in particular to try to push the agency to quicken its pace of getting new drugs to market for patients who need them. The FDA has also felt pressure of late to use its authority to govern e-cigarettes while it works to implement new food safety measures and to navigate the arrival of biosimilars, which are cheaper versions of biologic drugs.
In January, after being named as the FDA’s deputy commissioner for medical products and tobacco, Califf told reporters during a conference call that one of his priorities would be to streamline the clinical trial process, which should help facilitate his confirmation by Congress.