Dr. Robert Califf, vice chancellor for clinical and translational research, has been appointed the next deputy commissioner for Medical Products and Tobacco at the Food and Drug Administration.
In his new role, Califf will oversee the approval and regulation of drugs, medical devices and tobacco products in the United States. He will be in charge of both the FDA’s regulatory and policy efforts in those areas. Califf, who is a noted cardiologist, has conducted and overseen a large number of clinical trials for new drugs and medical procedures during his time at Duke.
He has taken a leave of absence from Duke to assume the position and anticipates returning to Duke after the next election, although there is some speculation that he could be named as the next FDA Commissioner. Plans to fill Califf’s position in his absence have not been announced.
“Dr. Califf’s deep knowledge and experience in the areas of medicine and clinical research will enable the agency to capitalize on, and improve upon, the significant advances we’ve made in medical product development and regulation over the past few years,” FDA Commissioner Dr. Margaret Hamburg said in a statement Monday.
During his time at the FDA, Califf will oversee major negotiations between the agency and drug providers over fees that the providers pay to the FDA. He will also be responsible for working with Congress to develop new rules for medicine and medical device approval.
“Congress is probably going to pass a set of laws called 21st Century Cures,” Califf said. “That’s mostly an effort by Congress to speed up and enhance new technologies for diseases that don’t have a cure.”
Califf will also help to shape the agency’s response to new medical innovations. Some of these new technologies cut across the standard regulatory frameworks which the agency has in place.
“What do you do when a drug is put in a device or when a biological graft is put in a device?” he asked. “There are different laws governing each component but no laws to tell you what to do when they are put together.”
Califf said that he hopes to specifically address the proliferation of new electronic health records and make improvements to the clinical trial process at the FDA.
“My particular career specialty has been clinical trial design and efficiency,” he said. “There’s huge support everywhere now to streamline clinical trials. Making studies better—what could be more interesting?”
Although details on how Califf’s position will be filled during his absence have not been announced, Califf wrote in a letter to Duke Translational Medicine and Duke Clinical Research Institute employees that transition plans are being implemented.
Following his recent appointment, here has been some media speculation that Califf might be appointed as the next commissioner of the FDA. He has been through the vetting process for the position twice, once during the Bush administration and again during the Obama administration. Califf said that he is focused on his current appointment, but added that he would be interested in becoming commissioner if appointed.
“That’s an appointment that’s not up to me,” he said. “If people think I’m the right person for that job at some time when I’m not too old and worn out, of course I’d always be interested.”
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