Dr. Robert Califf, a cardiologist and clinical researcher long affiliated with Duke University, was nominated by President Obama earlier this month to head up the FDA. Though Califf must face Senate confirmation before taking on the new role at the FDA, it is unlikely he will face any significant opposition.
Califf, if confirmed, will replace Dr. 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. Califf 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.
Dr. Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic, said of Califf: “He’s widely respected by the medical community and represents a terrific choice to lead the FDA. He has good ideas, but he doesn’t run over people with them. He will get along well with Congress.”
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 he was tapped to be 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.