Top Cardiologist to Oversee U.S. Policy on Medical Products

The U.S. Food and Drug Administration named prominent clinical researcher Robert Califf to be deputy commissioner for tobacco and medical products.

In his new role, Califf will provide executive leadership for CDRH, helping to advise the commissioner on priorities and policy setting for device and diagnostics oversight.

Califf will take on the long-vacant role at the end of February. He currently is a professor of medicine and vice chancellor for clinical research at Duke University, where he has worked for 33 years.

Because of the broad range of the deputy commissioner’s duties and focus on administrative tasks, such as management and ensuring regulatory consistency, he’s not expected to make broad changes, says Steven Grossman, president of HPS Consulting. However, Califf may make a personal priority out of improving clinical trial design, he adds.

Focus on Scientific Rigor

Steve Niedelman, lead quality systems and compliance consultant to the FDA and lifesciences practice team at King & Spalding, seconds that assessment. “I think he’ll focus a lot on scientific rigor, including improving clinical trials,” he tells IDDM. While most of Califf’s medical product experience has been in the area of pharmaceuticals, his clinical expertise can be expected to also resonate with device issues, he says.

A 1978 graduate of Duke’s medical school, Califf was a founding director of the Duke Clinical Research Institute — the world’s largest academic research organization. He is principal investigator for the NIH Health Care Systems Research Collaboratory, a co-director of the National Patient-Centered Clinical Research network and serves on several Institute of Medicine panels.

Califf is editor-in-chief of the American Heart Journal and has authored or coauthored more than 1,100 articles. Recent topics include the ClinicalTrials.gov database and clinical studies in India.

The FDA established the Office of Medical Products and Tobacco in 2011. The last permanent deputy commissioner, Stephen Spielberg, left the agency in January 2013. Following his departure, the role was briefly filled by former Johnson & Johnson executive Leona Brenner-Gati. She left the agency in May 2013.
— Elizabeth Orr