Biden will nominate Califf to head FDA

President Joe Biden on Friday said he would nominate Robert Califf to lead the U.S. Food and Drug Administration, and urged the Senate to swiftly confirm him.

Here's White House Press Secretary Jen Psaki:

"The president chose Dr. Califf - and this was in his statement, but let me reiterate this - because he's one of the most experienced clinical trialists in the country, he 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."

Califf is a 70-year-old cardiologist and served as FDA commissioner for 11 months at the tail end of then-President Barack Obama's second term.

The FDA oversees everything from medicine and medical devices to food, tobacco and cosmetics. And it has been without a permanent leader since Biden took office nearly nine months ago.

If confirmed by the Senate, Califf will take over from longtime FDA veteran Janet Woodcock, who has been serving as acting commissioner for the agency.

Woodcock could not legally serve past Monday unless a permanent nominee was named. Biden thanked her for her work over the past year.

The U.S. regulatory agency has been in the spotlight as it reviews vaccines and potential treatments for COVID-19.

It also came under additional scrutiny for its accelerated approval this year of Biogen's Alzheimer's drug, Aduhelm, against the recommendation of its outside expert advisers.

Under President Obama, Califf was confirmed for his first term by a Senate vote of 89-4 with broad bipartisan support...

...though 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.

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.

The White House said it was confident Califf would be confirmed.

"Every senator can vote for or against people who are nominated, that's their role. But we feel he is a qualified person who has the exact experience for this moment."

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

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