(WASHINGTON) – President Joe Biden on Friday is calling on former Food and Drug Administration (FDA) commissioner Robert Califf to lead the powerful regulator again, according to a person familiar with the decision. determined.
Califf’s nomination comes after months of concerns that the agency near the heart of the government’s COVID-19 response lacked a permanent leader. More than half a dozen names were chosen for the job before the White House settled in Califf.
Biden will make an official announcement late Friday, said a person familiar with the matter, who spoke on condition of anonymity to preview the announcement.
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A cardiologist and clinical trial specialist, Califf, 70, served as an FDA commissioner for the last 11 months of President Barack Obama’s second term. Before that, he spent a year as the agency’s No. 2 official after more than 35 years as a distinguished researcher at Duke University, where he helped design studies for many major drug manufacturers. best of the world.
Since leaving government, he has worked as a policy advisor for the tech giant Google, in addition to his current job at the Duke Clinical Research Institute.
If confirmed by the Senate, Califf will oversee decisions on a COVID-19 vaccine along with a host of other troubling issues, including regulation of e-cigarettes and effectiveness standards for prescription drugs. . He will be the first FDA commissioner since the 1940s back to lead the agency for the second time.
“Rob is a relatively safe choice because he is well known in Washington and widely respected,” said Wayne Pines, a former FDA commissioner who helped several commissioners with the confirmation process. “He will receive broad support from FDA stakeholders.”
The FDA regulates the vaccines, drugs, and tests used to fight COVID-19. It is its usual mandate to regulate a wide range of goods and medicines for consumers, including prescription drugs, medical devices, tobacco products, cosmetics and most foods.
Dr. Janet Woodcock, the agency’s longtime director of drugs, has served as commissioner since January. For months, she was expected to be chosen for the permanent position, but her nomination was met with opposition from key Democratic lawmakers, including Senator Joe Manchin of the West. Virginia, on handling opioid prescription pain relievers during her 30+ years at the agency.
The White House faces a legal deadline of mid-November to nominate a permanent commissioner or appoint another acting commissioner.
Califf came to the FDA in 2015 determined to modernize the way the agency reviews drug and device research data. But his brief stint as commissioner has been dominated by unrelated pharmaceutical controversies, including growing opioid addiction and overdoses.
He was one of the first FDA officials to publicly acknowledge the agency’s oversights of pain relievers like OxyContin, which are blamed for the ongoing opioid epidemic, now caused by heroin and fentanyl.
“If opioid addiction and opioid abuse are the enemy, then we at the FDA — like every other segment of society — have underestimated the enemy’s persistence,” Califf told The Associated Press in an interview last year. 2016. “So we have to adjust.”
Califf’s extensive work with the pharmaceutical industry drew scrutiny during his Senate confirmation hearing, though he was ultimately confirmed by an overwhelming margin. Due to the urgent need for a permanent commissioner, he is expected to win bipartisan confirmation again. He also has the backing of powerful medical device and pharmaceutical lobbying groups in Washington.
Califf has served as an advisor to several large pharmaceutical companies and sits on the boards of two smaller biotech companies.
Federal rules of ethics do not require government officials to sell all of their investments, but they must repurpose themselves from problems that might affect those investments. As part of the vetting process, FDA nominees often disclose and sell stocks, funds, and other investments that could create a financial conflict of interest.
FDA watchers say Califf has several key advantages over other candidates who have been screened for the job, some of whom will face closer scrutiny in the Senate.
“He knows how the FDA works and he has avoided making any outrageous decisions as commissioner,” said Diana Zuckerman of the nonprofit National Center for Health Research. “It’s essential if the FDA wants to regain the public’s trust.”
His first assignment will include alleviating burnout and lifting the morale of 18,000 FDA employees. The agency’s medical reviewers have been strained for months with workloads crushing the coronavirus pandemic, while the agency’s reputation for scientific independence has been battered by a series of controversies. public controversy.
Two congressional committees are investigating the agency’s June approval of the controversial drug Aduhelm against recommendations by outside experts, three of whom have resigned over the decision. this. Then in September, two of the FDA’s top vaccine regulators announced they were leaving the agency after disagreeing with the Biden Administration’s plan to make the boosters widely available. COVID-19 vaccine.
In recent weeks, the FDA has authorized the addition of additional doses of all three COVID-19 vaccines to certain groups, though not as widely as Biden initially suggested. Pfizer recently applied to expand eligibility for its booster program to all adults, a requirement the FDA is expected to grant.
The FDA’s latest troubles come after months of turmoil between the agency and the White House under President Donald Trump, who falsely accused the agency of deliberately slowing down the review of a COVID-19 vaccine to sway the presidential election.
