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

[February 16, 2022]  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 13 months after it last had a permanent leader.

His confirmation comes as the FDA reviews vaccines and treatments for COVID-19. The agency oversees everything from medicine and medical devices to food, tobacco and cosmetics.

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.

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 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.

Food and Drug Administration Commissioner nominee Doctor Robert Califf (C) arrives to testify during his nomination hearing before the Senate Health, Education, Labor and Pensions Committee on Capitol Hill in Washington, November 17, 2015. REUTERS/Gary Cameron/File Photo

"It is clear that Dr. Califf will not fight for life, and I cannot support his nomination," Republican Senator Jim Inhofe of Oklahoma, who voted in favor of Califf in 2016, said in a statement after the vote.

'EXCITING MOMENT FOR BIRTH CONTROL'

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, as did PhRMA, the leading pharmaceutical industry trade group.

John Serio, partner at law firm Withersworldwide who focuses on the pharmaceutical industry, said Califf brings unique experience to the role.

"You have somebody now heading the agency that understands the drug discovery process in great detail and understands it not only from an industry standpoint, but also from the agency standpoint," he said.

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 had previously advised Verily executives on clinical matters for potential products.

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, government records show.

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

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