Former FDA commissioners endorse Dr. Robert Califf to lead agency

Six former FDA commissioners on Dec. 13 endorsed Robert Califf, MD, as the next permanent head of the agency amid the COVID-19 pandemic.

In a letter to the Senate Health, Education, Labor and Pensions Committee, the former commissioners cited the need to address the omicron variant, which has been detected in at least 33 states and accounts for about 3 percent of new U.S. COVID-19 cases. 

"Confirming Dr. Califf is critical not only for moving beyond the COVID-19 emergency, but also to help meet FDA's many other major regulatory responsibilities where Senate-confirmed leadership is essential for the nation’s well-being," the former commissioners stated.

The FDA is responsible for the regulation of more than $2.7 trillion worth of food, medical products and tobacco, according to the agency's website.

The former commissioners said confirming Dr. Califf, also a former FDA commissioner, will also "help ensure that the FDA is well positioned to adapt and respond to these critical public health issues."

Dr. Califf was nominated in November by President Joe Biden. The cardiologist and teacher at the Duke University School of Medicine in Durham, N.C., was FDA commissioner from 2016-17, during President Barack Obama's administration.

After leaving the FDA, Dr. Califf joined Google parent company Alphabet in 2017 as an adviser before moving up the organization's ranks as head of strategy and policy for Alphabet's Verily Life Sciences and Google Health divisions by November 2019.

Dr. Califf also previously served as deputy commissioner of the FDA's Office of Medical Products and Tobacco.

In their letter, the six former FDA commissioners said Dr. Califf "has the experience to be effective from day one."

The letter — signed by Scott Gottlieb, MD; Margaret Hamburg, MD; Jane Henney, MD; Mark McClellan, MD, PhD; Stephen Hahn, MD; and Andrew C. von Eschenbach, MD — comes as the Senate Health, Education, Labor and Pensions Committee is scheduled Dec. 14 to conduct a hearing on Dr.Califf's nomination. 

While former FDA commissioners support Dr. Califf's nomination, some Democrats oppose it, citing his past work with drug companies as well as the FDA's handling of opioids, The Washington Post reported. 

"I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic," Sen. Joe Manchin III, D-W.Va., said in a statement Nov. 12. "Dr. Califf's nomination and his significant ties to the pharmaceutical industry take us backwards, not forward."

If confirmed by the full Senate, Dr. Califf would be the first permanent FDA leader under President Biden. Janet Woodcock, MD, has been serving as acting head of the agency.

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