CYTK

Cytokinetics, Incorporated

52.68
USD
-1.61%
52.68
USD
-1.61%
29.10 54.74
52 weeks
52 weeks

Mkt Cap 4.47B

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

WASHINGTON, Feb 15 (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. 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. 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. 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 Committee on Health, Education, Labor and Pensions in a December confirmation hearing that he trusted the FDA to make the right decision as it considered easing abortion pill restrictions, which it did two days later. 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 GOOGL.O in 2019 as head of clinical policy and strategy across its Google Health and Verily Life Sciences enterprises. Califf had served as an adviser at Verily since 2017. He advised 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 CYTK.O 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. Merck & Co MRK.N accounted for 40% of the total sum, according to data from the U.S. Centers for Medicare & Medicaid Services. The other companies in order of contribution amounts are AstraZeneca Plc AZN.L, Amgen Inc AMGN.O, Boehringer Ingelheim, Biogen Inc BIIB.O, Eli Lilly and Co LLY.N, Daiichi Sankyo Co 4568.T, Sanofi SA SASY.PA, Bayer AG BAYGn.DE, and Roche Holding AG ROG.S. (Reporting by Moira Warburton and Ahmed Aboulenein; Editing by Bill Berkrot) ((doina.chiacu@thomsonreuters.com; 202-898-8322;)) The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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