(WASHINGTON) — President Joe Biden on Friday is tapping former Food and Drug Administration (FDA) commissioner Robert Califf to again lead the powerful regulatory agency, according to a person familiar with the decision.
Califf’s nomination comes after months of concern that the agency near the center of the government’s COVID-19 response has lacked a permanent leader. Califf was one of more than twenty names that were offered for the role before it was finally settled by the White House.
Biden will make the official announcement Friday night, according to a person who was familiar with the matter. The source spoke under anonymity in order to give a preview of the announcement.
A cardiologist and clinical trial specialist, Califf, 70, served as FDA commissioner for the last 11 months of President Barack Obama’s second term. Before that, he spent one year as the agency’s No. 2 official after more than 35 years as a prominent researcher at Duke University, where he helped design studies for many of the world’s biggest drugmakers.
After leaving the government, his work as a policy consultant to Google and at the Duke Clinical Research Institute has continued.
Califf, if confirmed by the Senate would be responsible for COVID-19 vaccinations and a host of other issues such as regulation of electronic cigarettes or effectiveness standards of prescription drugs. Californiaf would become the FDA’s first commissioner to return since the 1940s and lead the agency for the second time.
“Rob is a relatively safe choice because he is known in Washington and is widely respected,” said Wayne Pines, a former FDA associate commissioner who has helped several commissioners through the confirmation process. “He will have broad support from FDA stakeholders.”
FDA oversees vaccines and drug testing to counter COVID-19. That’s on top of its normal duties regulating a swath of consumers goods and medicines, including prescription drugs, medical devices, tobacco products, cosmetics and most foods.
Dr. Janet Woodcock, the agency’s longtime drug director, has been serving as acting commissioner since January. Her nomination for permanent office was anticipated. However, she ran into opposition from prominent Democratic lawmakers including Senator Joe Manchin (West Virginia) over her handling opioid prescription painkillers.
Mid-November was the legal deadline for the White House to name a permanent or acting commissioner.
Califf joined the FDA as a commissioner in 2015. He was determined to improve the FDA’s process of reviewing data from device and drug studies. However, his short time as Commissioner was overshadowed by non-pharmaceutical controversies like the rising epidemic of opioid addiction and overdoses.
He was among the first FDA officials to publicly acknowledge missteps in the agency’s oversight of painkillers like OxyContin, which is widely blamed for sparking the ongoing opioid epidemic, now driven by heroin and fentanyl.
“If addiction to opioids and misuse of opioids is an enemy then we at the FDA—like every other part of society—underestimated the tenacity of the enemy,” Califf told The Associated Press in a 2016 interview. “So we’ve got to adjust.”
Califf’s extensive work with the drug industry drew scrutiny during his Senate confirmation hearing, though he was ultimately confirmed by an overwhelming margin. Because of the need for a permanent commission, he will likely be confirmed by both parties again. The powerful Washington lobbying organizations for pharmaceuticals and medical devices support him.
Califf worked as an advisor for many major pharmaceutical companies. He also sits on the boards of two smaller biotech firms.
The federal ethics regulations do not mandate that government officials must sell all of their investments. However, they are required to withdraw from any matters that may affect these investments. FDA nominees usually disclose stock, funds, and other investments that might pose a conflict of financial interest to the FDA vetting committee.
FDA observers said that Califf has several advantages over the other applicants vetted to the job. Many of them would face more scrutiny by the Senate.
“He knows how the FDA works, and he avoided making any outrageous decisions as commissioner,” said Diana Zuckerman of the non-profit National Center for Health Research. “Those are essential if the FDA is going to regain the public trust.”
His first tasks would include easing burnout and boosting morale among the FDA’s 18,000 employees. The agency’s medical reviewers have been straining for months under a crushing coronavirus pandemic workload, while the agency’s reputation for scientific independence has been battered by a string of public controversies.
Two congressional committees are investigating the agency’s June approval of the much-debated Alzheimer’s drug Aduhelm against the recommendation of its outside experts, three of whom resigned over the decision. Two FDA officials who were top regulators of vaccines announced that they will be leaving the agency in September after opposing the Biden Administration’s plans to increase COVID-19 vaccine boosters availability.
The FDA granted additional doses of the three COVID-19 vaccinations to certain populations in recent weeks, but not as widely as Biden had originally suggested. Pfizer applied recently to extend eligibility for the booster to all adults. The FDA will likely grant this request.
After months of tension between FDA and President Donald Trump’s White House, the latest FDA problems follow false accusations that the White House deliberately slowed down its COVID-19 vaccinations review to influence the election.