Obama taps cardiologist to oversee FDA

President Barack Obama nominated Dr. Robert Califf, currently the Deputy Commissioner for Medical Products and Tobacco at the FDA, as the next commissioner of the agency. A leading cardiologist and researcher, Califf would head the agency that oversees everything from food and drugs to tobacco to dietary supplements and cosmetics for the final 16 months of the Administration.

Medical innovations

Califf has served as a deputy FDA commissioner since March and is considered a strong advocate of speeding up the development of medical innovations, a cause that is getting increased support from both the White House and Congress (see Faster, please:expedited drug approval pathways increasingly popular, Health Law Daily, July 2, 2015). The U.S. House of Representatives passed a bill known as the 21st Century Cures Act that would require the FDA, among other things, to consider more flexible forms of clinical trials and incorporate patient experience into its review process (see House welcomes 21st century medicine and hopes Senate is forward looking too, Health Law Daily, July 10, 2015). Although the Senate will not take up the House-passed bill in 2015 because of timing issues for a floor vote, senators will incorporate those ideas into a new bill that the Senate intends to vote on in 2016.

Confirmation

The position is subject to confirmation by the Senate, but industry observers do not expect him to face significant opposition. Sen. Lamar Alexander (R-Tenn), chairman of the Senate Health, Education, Labor and Pensions Committee, noted Califf’s “impressive credentials” and stated that the committee would move “promptly” on considering the nomination.

Califf was formerly the vice chancellor of clinical and translational research at Duke University and founded the Duke University Clinical Research Institute in 2006, as well as serving as its director. Califf also served on the Executive Committee of the Duke Health System.