Biden will nominate Califf to head FDA

WASHINGTON: President Joe Biden on Friday (Nov 12) said he would nominate Robert Califf to lead the US Food and Drug Administration and urged the Senate to swiftly confirm him.

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.

"Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation's fight to put an end to the coronavirus pandemic," Biden said in a statement issued by the White House.

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. Biden thanked her for her work over the past year.

The US 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. At the time he had 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.

"Dr Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr Califf so he can continue the important work being done at this critical moment," Biden said in the White House statement.

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 recognised expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine, the White House said. He is a longtime faculty member at Duke University, where he founded the Duke Clinical Research Institute.

As deputy FDA commissioner for medical products and tobacco in 2015, Califf worked closely with then-Vice President Biden on Cancer Moonshot, an initiative aimed at speeding development of cancer treatments.

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