Biden expected to nominate Califf to head FDA

By Andrea Shalal

WASHINGTON (Reuters) – President Joe Biden is expected to nominate former commissioner Robert Califf to lead the U.S. Food and Drug Administration once more on Friday, a source familiar with the decision told Reuters.

Califf, 70, a well-regarded cardiologist and researcher, served as FDA commissioner from February 2016 until the end of then-President Barack Obama’s second term in January 2017.

The FDA has been without a permanent leader since Biden took office nearly nine months ago.

If the nomination is confirmed by the Senate, Califf will take over from longtime FDA veteran Janet Woodcock, who has been serving as acting commissioner for the agency. The FDA oversees everything from medicine and medical devices to food, tobacco and cosmetics.

Woodcock has been in the role since Biden took office but legally could not serve past Monday unless a permanent nominee was named.

The U.S. regulatory agency has been in the spotlight as it reviews vaccines and potential treatments for COVID-19, and came under additional scrutiny for its accelerated approval this year of Biogen Inc’s Alzheimer’s drug, Aduhelm, against the recommendation of its outside expert advisers.

Califf was confirmed for his first term by the Senate 89-4 with broad bipartisan support, though at the time he faced opposition from some Democrats over his ties to the drug industry, having at the time co-authored papers with industry executives and served as a consultant for drugmakers.

He has served as an adviser to Alphabet Inc’s life sciences division, Verily Life Sciences, and Google Health, since 2019.

The Democrats have a razor-thin majority in the Senate. Senator Joe Manchin, who opposed Califf’s first nomination, said on Friday he would do so again.

“Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward,” Manchin said in a statement.

Califf is an internationally recognized expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine. He is a longtime faculty member at Duke University.

(Refiling to fix Update number to make it Update 2)

(Reporting by Andrea Shalal in Washington; Additional reporting by Katharine Jackson, Mrinalika Roy, and Ahmed Aboulenein; Editing by Bill Berkrot and Raissa Kasolowsky)

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