According to people familiar with the matter, President Joe Biden is hiring former Food and Drug Administration Director Robert Calif on Friday to lead this powerful regulatory agency again.
Califf’s nomination was made after months of concerns about the lack of permanent leaders in agencies near the government’s COVID-19 response center. Before Califf was selected by the White House, more than six names were nominated for this job.
The person familiar with the matter, who asked not to be named, said that Biden will officially announce the news later on Friday.
Califf, a 70-year-old cardiologist and clinical trial expert, served as an FDA commissioner during the last 11 months of President Barack Obama’s second term. Prior to this, after more than 35 years as a distinguished researcher at Duke University, he served as the agency’s second officer for one year, where he helped many of the world’s largest drugmakers design research.
After leaving the government, in addition to continuing to work at the Duke Clinical Research Institute, he also served as a policy adviser to the tech giant Google.
If confirmed by the Senate, Califf will oversee the decision on the COVID-19 vaccine and a series of other thorny issues, including the regulation of e-cigarettes and the effectiveness standards of prescription drugs. He will become the first FDA commissioner to assume the leadership role of the agency again since the 1940s.
“Rob is a relatively safe choice because he is widely known and respected in Washington,” said Wayne Pines, a former FDA deputy commissioner, who has helped several commissioners complete the confirmation process. “He will receive broad support from FDA stakeholders.”
The FDA regulates vaccines, drugs, and tests used to fight COVID-19. This is the normal duty of overseeing a range of consumer products and medicines, including prescription drugs, medical devices, tobacco products, cosmetics and most foods.
Dr. Janet Woodcock, the agency’s long-term drug director, has been acting commissioner since January. She has been expected to get a permanent position for several months, but her nomination has been opposed by major Democratic lawmakers, including Senator Joe Manchin of West Virginia, because she has handled opioid prescription pain relief during more than 30 years at the agency medicine.
The White House faces a statutory deadline of mid-November for nominating a permanent commissioner or appointing another acting commissioner.
Califf arrived at the FDA in 2015, determined to modernize the agency’s way of reviewing drug and device research data. But his short time as a commissioner was dominated by unrelated drug controversies, including epidemics of opioid addiction and overdose.
He is one of the first FDA officials to publicly admit that the FDA has misregulated OxyContin and other painkillers. OxyContin has been widely blamed for triggering the ongoing opioid epidemic driven by heroin and fentanyl.
“If opioid addiction and opioid abuse are the enemy, then we at the FDA, like all other parts of society, underestimate the enemy’s tenacity,” Kalif told The Associated Press in a 2016 interview. “So we have to adjust.”
Califf’s extensive collaboration with the pharmaceutical industry was reviewed at the Senate’s confirmation hearing, although he was eventually confirmed by an overwhelming advantage. In view of the urgent need for a permanent commissioner, he is expected to win the confirmation of the two parties again. He also has the support of powerful pharmaceutical and medical device lobby groups in Washington.
Califf has served as a consultant for several large pharmaceutical companies and is a member of the board of directors of two smaller biotech companies.
Federal ethics rules do not require government officials to sell all investments, but they must avoid matters that may affect these investments. As part of the review process, FDA nominees usually disclose and sell stocks, funds, and other investments that may create a financial conflict of interest.
FDA observers said that Califf has several key advantages over other candidates, some of whom will face stricter scrutiny in the Senate.
“He knows how the FDA works, and as a commissioner, he avoids making any heinous decisions,” said Diana Zuckerman of the non-profit National Center for Health Research. “These are essential if the FDA wants to regain the trust of the public.”
His top priority will include reducing burnout and boosting morale among FDA’s 18,000 employees. For months, the agency’s medical examiners have been strained under the heavy workload of the coronavirus pandemic, while the agency’s reputation for scientific independence has been hit hard by a series of public controversies.
Two congressional committees are investigating the agency’s approval of the controversial Alzheimer’s drug Aduhelm in June. Despite the advice of outside experts, three of them resigned due to the decision. Then in September, the FDA’s two top vaccine regulators announced that they would leave the agency after disagreeing with the Biden government’s plan to provide COVID-19 vaccine boosters widely.
In recent weeks, the FDA has authorized additional doses of all three COVID-19 vaccines for certain groups, but the scope is not as broad as Biden originally proposed. Pfizer recently applied to extend its booster qualifications to all adults, and the FDA is expected to approve this request.
The latest FDA troubles occurred after months of turmoil between the agency and the White House under President Donald Trump, who falsely accused the agency of deliberately slowing down its COVID-19 vaccine review to influence the presidential election.