(Fixes typo in subhed)
* President Joe Biden to nominate Robert Califf as FDA chief
* Key drug regulator without permanent leader since January
* Califf led the agency under President Barack Obama
* Nominee criticized for pharmaceutical industry ties
WASHINGTON, Nov 12 (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
"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.
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.
"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)