President Joe Biden is reportedly close to picking Robert Califf to lead the U.S. Food and Drug Administration by the November deadline. Pictured: Califf testifies during his nomination hearing before a Senate committee, November 2015
President Joe Biden is reportedly close to choosing a new head to lead the U.S. Food and Drug Administration (FDA) – and it’s a familiar name.
Robert Califf, who was FDA Commissioner between February 2016 and January 2017, is the top pick once again to lead the federal health agency, three sources who spoke on the condition of anonymity told The Washington Post.
The role is currently held by Acting Commissioner Dr Janet Woodcock, who assumed the title in January 2021.
A full-time commissioner must be named soon, because Woodcock cannot hold the title past November.
Califf would come back to the FDA as it has several high-profile decisions to make.
The new commissioner will be responsible for seeing out the end of the COVID-19 pandemic – especially as relates to boosters and vaccines in young children – and handling recent controversies related to the agency such as the approval of a new Alzheimer’s drug despite scant evidence.
Robert Califf led the FDA for less than one year during the end of the Obama administration and was confirmed on February 22, 2016 in an 89-4 vote.
Califf, a cardiologist with ties to the pharmaceutical industry, previously led the FDA for less than a year from February 2016 to January 2017, when Biden was Vice President. Pictured: Biden delivers an update on the COVID-19 response and vaccination program, October 14
The new commissioner will be responsible for seeing out the end of the COVID-19 pandemic and handling recent controversies related to the agency. Pictured: Signage is seen outside of the FDA headquarters in White Oak, Maryland
The Post reports that his nomination was met with opposition from some Senators such as Bernie Sanders of Vermont, who criticized his ties to the pharmaceutical industry.
Califf graduated from Duke University School of Medicine in 1978 and began an internal medicine residency in North Carolina, only to switch to cardiology.
He was a professor of cardiology at Duke from 1980 to 2015 and founding director of the Duke Clinical Research Institute, which is the self-proclaimed ‘largest academic research organization’ in the world.
Califf had close ties to pharmaceutical companies, convincing them to fund large trials at Duke, and was a paid consultant for firms such as Johnson & Johnson, Merck & Co and Eli Lilly.
In January 2015, he was appointed Deputy Commissioner of the FDA’s Office of Medical Products and Tobacco before becoming head of the entire agency.
He stepped down in January 2017 and Scott Gottlieb took over the role as the first FDA chief during the Trump administration.
On Thursday, White House press secretary Jen Psaki said Biden has not yet made a final decision.
‘We are certainly eager to do this in short order,’ she said.
Prior to the news that Califf is the front-runner for the job, POLITCO reported that at least four others were being considered.
Dr Janet Woodcock (pictured) is the Acting Commissioner of the agency, though her interim tenure is set to end next month. She faces opposition from some Democrats in the Senate
Dr Laurie Glimcher (pictured) was among the favorites to be named FDA commissioner by President Joe Biden. She currently serves as president and CEO of the Dana-Farber Cancer Institute
The shortlist included Woodcock, Dr Laurie Glimcher of the Dana-Farber Cancer Institute, Dr Joshua Sharfstein of Johns Hopkins University and Michelle McMurry-Heath of the Biotechnology Innovation Organization.
Woodcock was named acting commissioner upon Biden’s inauguration, replacing Dr Stephen Hahn, a Trump appointee who resigned amid the start of a new administration.
She was among those being considered for the role, but a few Senators have vocally opposed her appointment to the role – Senators she would need to confirm her appointment due to the slim margin Democrats currently hold in the Senate.
Sens Maggie Hassan of New Hampshire, Ed Markey of Massachusetts and Joe Manchin of West Virginia have all been critics of Woodcock.
Sen Manchin could prove to be a barrier in particular, because he has shown willingness to break from party lines.
The Senators, all from states that have struggled due to America’s opioid epidemic, place some of the blame for the problem of the Center for Drug Evaluation and Research which is led by Woodcock.
Dr Joshua Sharfstein (pictured) was considered for the FDA commissioner role under Obama in 2008, though missed out on the role after facing some internal opposition
Dr Michelle McMurry-Heath is another former Obama official being considered for the role. She is currently president and CEO of the Biotechnology Innovation Organization
Dr Glimcher is the president and CEO of the Dana-Farber Cancer Institute.
POLITICO reported her nomination could face a few roadblocks as well because she has industry ties that require her to divest from some of her holdings.
Dr Sharfstein is a former Obama-era FDA official who currently serves as vice dean for public health practice at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland.
He was reportedly a finalist for commissioner of the agency under Obama, when Biden was vice president, but was eventually named Principal Deputy Commissioner of the agency.
Dr McMurry-Health is also a former Obama-era FDA official, and she is currently the president and CEO of the Biotechnology Innovation Organization – an advocacy group that represents over 1,000 biotech firms in more than 30 countries.
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