Cardiologist confirmed to head FDA

Dr. Robert Califf, a cardiologist, was confirmed on Tuesday to head the U.S. Food and Drug Administration in a 50-46 senate vote.

Califf previously was confirmed to run the agency during President Obama’s last year in office by an 89-4 vote. He previously served as the FDA’s deputy commissioner for medical products and tobacco. Prior to his FDA assignments, he was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He was also director of the Duke Translational Medicine Institute and is the founding director of the Duke Clinical Research Institute.

Six Republicans voted for him and five Democrats voted against him, most notably Sen. Joe Manchin of West Virginia who expressed concerns about Califf’s ties to the pharmaceutical industry. Manchin wants the FDA to be more focused on stopping the opioid epidemic and does not believe Califf is the right person to change the culture at the FDA to do so.

Sen. Elizabeth Warren, a Massachusetts Democrat voted yes after meeting with Califf and asking him to sign an ethics pledge that mandates that he won’t work for any company he oversees at the FDA for at least four years after he finishes. Califf signed the pledge.

He also faced opposition from a coalition of pro-life groups, including the Susan B. Anthony List, after he said during his confirmation hearing that he trusted the FDA’s process about the agency’s decision to allow abortion pills to be sent by mail.

The last time he was head of the FDA, Califf oversaw the 2016 approval of eteplirsen, a drug used to treat Duchenne muscular dystrophy. Califf backed now-acting commissioner Dr. Janet Woodcock, who went against the FDA's independent advisory group that recommended against eteplirsen's approval.

Califf is board-certified in internal medicine (1984) and cardiology (1986), and a Master of the American College of Cardiology (2006).

This article was originally published on Medical Economics®.