Dr. Robert Califf Confirmed as New FDA Head

Dr. Robert Califf is once again the commissioner of the U.S. Food & Drug Administration (FDA).

By a vote of 50-46, Califf was confirmed by the U.S. Senate on Tuesday. The key “yes” vote came from Sen. Pat Toomey (R-Pa.), one of five Republicans who missed a procedural vote for advancing Califf’s nomination on Monday.

Califf was nominated last November, though it became apparent he would be the nominee in October. He has worked for Duke University for most of his career, where he was a professor of cardiology. However, this is not his first stop at FDA.

In early 2015 he was named deputy commissioner of FDA’s Office of Medical Products and Tobacco and he served as FDA commissioner during the final year of the Obama Administration. That means he was the commissioner in charge of FDA when the agency finalized its deeming regulations, marking the first serious regulations of cigars and other tobacco products in the U.S. His confirmation to the post in February 2016 was quite a bit different than the one he’s experienced this time around; he was confirmed then by a vote of 89-4.

However, a more divisive political environment and Califf’s own past made this nomination a lot more contentious. Five members of the Democratic caucus voted against Califf’s nomination, largely over concerns regarding FDA’s handling of the opioid crisis—including while he was in charge—and also Califf’s close times to the pharmaceutical industry.

Califf is now responsible for leading FDA’s next landmark tobacco policy, the agency’s plans to ban flavored tobacco products in the U.S. In addition, this spring, FDA is expected to make a decision regarding whether premium cigars will be required to go through a previously-announced product approval process or adopt a unique approach for premium cigars.