Obama to nominate Califf as next FDA head
President Barack Obama is set to nominate Dr. Robert Califf as the next Commissioner of the FDA, according to a press release from the White House.
Califf joined FDA in February of this year after 30 years with Duke University in Durham, NC, as a cardiologist, medical professor and researcher. He is taking over for former FDA Commissioner Margaret Hamburg who resigned her post back in March after 6 years at the helm. In the interim, FDA’s acting commissioner has been Stephen Ostroff, M.D.
As FDA Commissioner, Califf will likely face many unfinished projects and potential challenges, including pending tobacco regulations, food safety and labeling reforms, and proposals from members of Congress intent on streamlining drug reviews.
Califf’s background as a drug researcher could make him receptive to some of the reforms coming out of Congress, though he has not testified on the legislation. The legislation could have a massive impact on the way in which FDA regulates nearly every medical product it oversees.
The FDA approved the highest number of new drugs past year in almost two decades. Moreover, knowledge present that the company’s typical time for approving medicine is considerably quicker than Europe’s or Japan’s.
In 2006, Califf founded the Duke University Clinical Research Institute, a contract research group that has conducted studies for virtually all of the world’s largest drugmakers. He is a graduate of Duke’s School of Medicine.
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.
A disclosure type filed with Duke College final yr exhibits Califf acquired analysis grants or consulting charges from a dozen drugmakers, together with Merck & Co., Roche and Eli Lilly & Co.