Biden will nominate industry-friendly Califf to lead U.S. FDA
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[November 13, 2021]
By Andrea Shalal and Ahmed Aboulenein
WASHINGTON (Reuters) - President Joe Biden
on Friday said he would nominate Robert Califf for a second stint as
commissioner of the U.S. Food and Drug Administration, and urged the
Senate to swiftly confirm him.
Califf, 70, a well-regarded cardiologist and researcher closely linked
with the pharmaceutical industry, 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.
Califf was confirmed for his first term by the Senate 89-4 with broad
bipartisan support, though at the time he faced criticism from some
Democrats, like Senators Bernie Sanders of Vermont and Joe Manchin of
West Virginia, who said his ties to the drug industry made him unfit to
regulate it impartially.
At the time, Califf had co-authored papers with industry executives and
served as a consultant for drugmakers. He was since hired by Google
parent Alphabet Inc in 2019, and currently serves as the head of
Clinical Policy and Strategy across its Google Health and Verily Life
Sciences enterprises.
He is also on the board of drugmaker Cytokinetics Inc and has received
consulting fees from pharmaceutical companies Amgen Inc, Boehringer
Ingelheim, Biogen Inc, Eli Lilly and Co, Roche AG's Genentech unit, and
Merck & Co Inc.
"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 leading U.S. pharmaceutical trade association welcomed his
nomination.
"We hope the confirmation process will proceed quickly, and we look
forward to continuing to work with the FDA as we fight the pandemic and
other deadly diseases," said Pharmaceutical Research and Manufacturers
of America President Steve Ubl.
SENATE CONFIRMATION
Democrats have a razor-thin majority in the Senate. Manchin said on
Friday he would oppose Califf's nomination.
"Dr. Califf's nomination and his significant ties to the pharmaceutical
industry take us backwards not forward," Manchin said in a statement on
Friday.
White House Press Secretary Jen Psaki said the Biden administration was
confident Califf would be confirmed, pointing to his experience and
prior confirmation.
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Food and Drug Administration Commissioner nominee Doctor Robert
Califf testifies at his nomination hearing at the Senate Health,
Education, Labor and Pensions Committee on Capitol Hill in
Washington, November 17, 2015. REUTERS/Gary Cameron/File Photo
"We feel he's a qualified person who has the exact
experience for this moment," Psaki said at a briefing, adding that
Manchin had ultimately voted to confirm him in 2015.
The FDA has been without a permanent leader since Biden took office
in January.
If confirmed by the Senate, Califf 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.
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 FDA 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 is an internationally recognized 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, a large academic center that received over half its
funding from the drug industry.
He joined the FDA in 2015 as deputy commissioner for Medical
Products and Tobacco and worked closely with then-Vice President
Biden on Cancer Moonshot, an initiative aimed at speeding
development of cancer treatments.
(Reporting by Andrea Shalal and Ahmed Aboulenein; Additional
reporting by Katharine Jackson, Mrinalika Roy, Susan Cornwell, and
Susan Heavey; Editing by Bill Berkrot, Raissa Kasolowsky, Aurora
Ellis and Jonathan Oatis)
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