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 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.
[to top of second column] |
 White House Press Secretary Jen
Psaki said the Biden administration was
confident Califf would be confirmed, pointing to
his experience and prior confirmation.
"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.
(This story fixes typo in subhed.)
(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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