U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time

By Ahmed Aboulenein

WASHINGTON (Reuters) -The U.S. Senate on Tuesday voted to confirm Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration after some senators had argued his ties to the pharmaceutical industry or views on birth control made him unfit for the role.

Calif, 70, is a well-regarded cardiologist and researcher who takes the helm at the FDA for a second time over a year after the health regulator last had a permanent leader. His confirmation comes at a pivotal moment as the agency reviews vaccines and treatments for COVID-19.

Califf previously served as FDA commissioner from February 2016 until the end of President Barack Obama’s second term in January 2017.

He will take over from longtime FDA veteran Janet Woodcock, who has been serving as acting commissioner. Woodcock congratulated Califf on Tuesday and said she would be staying on as principal deputy.

The FDA oversees everything from medicine and medical devices to food, tobacco and cosmetics.

His nomination by President Joe Biden was opposed by five of Biden’s fellow Democrats including Vermont Senator Bernie Sanders, who said Califf’s work with pharmaceutical companies made him unfit to regulate the industry impartially, and West Virginia Senator Joe Manchin, who criticized how the agency handled the opioid crisis under Califf’s leadership.

“Dr. Califf was there five years ago. He’s coming back. Nothing’s changed; 400,000 people have died (from opioids) since he was there,” Manchin said before the vote.

Califf was confirmed by a narrow margin three months after Biden nominated him as six Republicans joined with the remaining Democrats, resulting in 50 votes in favor and 46 against. One senator voted present.

Senator Richard Burr of North Carolina, the ranking Republican on the health committee, urged members of his party to support Califf before the vote.

“He has the robust agency and private sector experience needed to help build on the success of the FDA in helping Americans get back to normal life,” said Burr. “He’s the leader we need today, but also for the future.”

The battle over Califf stood in stark contrast to the overwhelming bipartisan support he received ahead of his first time in the role, when 89 senators voted to confirm him.

Previous Republican backers said they withdrew their support after Califf told the Senate health committee in December that he trusted the FDA to make the right decision as it considered easing abortion pill restrictions, which it did two days later.

“The nomination of Robert Califf to be FDA commissioner endangers the well being of unborn babies, of women and girls,” Republican Senator Steve Daines of Montana, who voted in favor of Califf in 2016, said before the vote.

Reproductive rights advocates lobbying for FDA approval of over-the-counter oral contraceptives welcomed Califf’s confirmation.

“I think it’s a really exciting moment for birth control pills,” Victoria Nichols, project director of the Free the Pill campaign, told Reuters.

Cardiology group the American Heart Association and patient advocates UsAgainstAlzheimer’s both issued statements welcoming Califf’s confirmation.

Califf has co-authored papers with industry executives, served as a consultant for drugmakers, and following his first stint as FDA chief was hired by Google parent Alphabet Inc in 2019 as head of clinical policy and strategy across its Google Health and Verily Life Sciences enterprises.

Califf since 2017 had also advised Verily executives on clinical matters for potential products.

Alphabet has also backed Duke University’s AI for Health project in which Califf – a longtime cardiology professor and founding director of the Duke Clinical Research Institute and the university’s health data science center – was heavily involved.

Califf has been on the board of drugmaker Cytokinetics Inc since February 2018, the company’s website shows, and has received over $93,000 in consulting and other fees between 2014 and 2019 from nine drugmakers, according to government records.

(Reporting by Moira Warburton and Ahmed Aboulenein; Editing by Bill Berkrot)

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