Cardiologist Robert Califf Becomes New Commissioner of the FDA

After months of sometimes contentious debate, Robert M. Califf, MD, has been confirmed as the 22nd Commissioner of the US Food and Drug Administration.

The Senate vote was 88 to 4 in favor of confirming Califf, 64, a cardiologist and clinical researcher who has served as Deputy Commissioner of the agency’s Office of Medical Products and Tobacco since January 2015.

President Obama nominated Califf in September to replace Margaret A. Hamburg, MD, who stepped after 6 years as Commissioner.

Speaking on behalf of Califf prior to the vote, Sen. Patty Murray (D-WA), ranking member of the Health, Education, Labor & Pensions (HELP) committee, praised his experience and expertise, saying he would lead the FDA in a way that “puts patients and families first and upholds the highest standards of patient and consumer safety.”

Despite support from the majority of the Senate and an endorsement by the New England Journal of Medicine, several legislators opposed Califf’s nomination, including presidential candidate Sen. Bernie Sanders (I-VT), who repeatedly questioned his ties to industry.

In post-cloture debate prior to the final vote, Sen. Edward Markey (D-MA), another critic of Califf, reiterated his concerns that the FDA has refused to convene expert advisory panels on how to prevent the nationwide epidemic of opioid abuse and deaths. Markey insisted that as Deputy Commissioner, Califf has done nothing to change the situation and likely will not be an advocate for the type of change that is needed. Similarly, Sen. Kelly Ayotte (R-NH), expressed her concerns and said she hoped Califf would be “aggressive on this issue.”

Following the confirmation, the American College of Cardiology issued a statement from its president, Kim Allan Williams Sr, MD, congratulating Califf and calling him “the right person to lead the FDA.”

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