Dr. Califf acknowledged that he has some learning ahead of him to get up speed on the position, especially when it comes to tobacco.
“As a cardiologist, I’ve only had one theme with tobacco, which is ‘don’t smoke,’ ” he said. “I need a very rapid education about the specifics of tobacco. It’s a very complex issue. I’m not coming in from the outside to tell the center directors what to do. I’m really there to support them.”
Dr. Califf has held multiple roles at Duke, including director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. He is one of the Top 10 most-cited medical authors with more than 1,200 peer-reviewed publications, according to a Jan. 26 statement released from Duke. He is also an internationally recognized expert in cardiovascular medicine and health outcomes research and played a pivotal role in the development and leadership of the national Patient-Centered Outcomes Research Network. The network is designed to enhance the quality and relevance of clinical evidence used to guide health decisions.
Dr. Margaret A. Hamburg
Dr. Califf is currently a member of the Institute of Medicine (IOM) Policy Committee and a liaison to the IOM’s Forum in Drug Discovery, Development, and Translation. He was formally a member of the IOM committees that recommended Medicare coverage of clinical trials and the removal of the dietary supplement ephedra from the market, and a former member of the IOM’s Committee on Identifying and Preventing Medication Errors. In addition, he served on the FDA’s Cardiorenal Advisory Panel and on the Science Board’s Subcommittee on Science and Technology that reviewed the FDA in 2007.
The transition from academia to a regulatory agency will no doubt be challenging, Dr. Califf said. He joked that the hardest part may be not saying what’s on his mind immediately. However, overall, he said he is ready for change.
“Obviously, when you’re on the regulatory side, you have the ultimate responsibility for the public health and not just the well-being of the product you’re interested in,” he said. But “I have spent so much time on all sides of the FDA that I feel pretty comfortable with what the role is going to be.”
Dr. Stephen Spielberg last held the position of FDA deputy commissioner for medical products, serving from 2011 to 2013.
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