FDA Commissioner Margaret Hamburg appointed a Duke cardiologist with ties to biopharma as the agency's deputy commissioner for medical products and tobacco, stoking speculation that she's lining up a successor.
Robert Califf will join the FDA next month, presiding over its separate drug, biologic, medical device and tobacco wings. Califf, now vice chancellor of clinical research at Duke, will oversee the agency's changing policies in personalized medicine, orphan drugs and pediatric science, the FDA said, and he'll play a role in the all-important advisory committee system.
The surprise appointment has led many to conclude that Califf is Hamburg's pick to step in when she eventually retires. FDA commissioners are appointed by the president and approved by the Senate, but Hamburg could be trying to ease Califf in before a new administration takes over in 2017.
And Califf, with his decades of experience in the field, would stand up to scrutiny, FDA veteran Peter Pitts told Reuters.
"He is a guy who could very easily be FDA commissioner under any administration," said Pitts, the agency's former associate director for external relations. "He is one of the few candidates who could sail through the confirmation process because of his universally recognized talents."
Califf has straddled the line between academia and industry throughout his career, serving as the founding director of the Duke Clinical Research Institute, an in-house CRO that employs more than 1,000 people and has an annual budget of more than $100 million, according to the school. He later went on to run the Duke Translational Medicine Institute, which works with the National Institutes of Health to turn lab discoveries into actionable medicines.
Califf also led the 6-year IMPROVE-IT study, in which Merck's ($MRK) Zetia had a positive effect on cardiovascular outcomes, affirming the hopes of companies developing new cholesterol-lowering medicines. And, until today, Califf served on the board of Portola Pharmaceuticals ($PTLA), a biotech cooking up antidotes to next-generation anticoagulants.
Those years spent between labs and board rooms make him an ideal fit for the FDA, Hamburg said.
"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 last few years," she said in a statement.
Califf interviewed for FDA commissioner back in 2009, alongside Baltimore Health Commissioner Joshua Sharfstein and Hamburg, then head of the New York City Health Department. He also has a close relationship with Janet Woodcock, head of the agency's pharma branch, Reuters reports.
- read the FDA's announcement
- check out the Reuters story