Biden likely to tap Robert Califf to return as FDA head

President Biden is expected to nominate Robert Califf to lead the Food and Drug Administration (FDA), multiple sources familiar with the deliberations said Thursday.

Califf previously held the role of FDA commissioner during the Obama administration, where he served for less than a year. 

One source said the pick was not fully finalized amid back and forth with Califf about the job, but he is the likely choice.

A second said that the nomination is expected, calling Califf the favorite, but noted that the decision is not firm yet.

Under federal law, Biden faces a Nov. 15 deadline to pick a leader for the agency or nominate the current acting commissioner, Janet Woodcock. 

Woodcock has been leading the FDA since Biden was elected, but key Democrats have indicated they would not support her nomination because of what they view as her role in failing to control the opioid epidemic. 

The White House has stressed it wants its choice for the critical position to be someone with a smooth path to Senate confirmation, and it believes it has found that candidate in Califf. He was confirmed by a vote of 89-4 in 2016.

Sens. Joe Manchin (D-W.Va.), Ed Markey (D-Mass.) and Richard Blumenthal (D-Conn.) and former Sen. Kelly Ayotte (R-N.H.) voted against the nomination.

Senators at the time expressed concerns that he was too close to industry, because he had served as a consultant to drug and device firms. Since he left the agency, Califf advised Google Health and later ran health policy at its spinoff, Verily Life Sciences. He is currently a professor of cardiology at Duke University School of Medicine. 

Senators also expressed concern over opioids, but the opposition was focused more on the FDA’s role in regulating them as a whole than Califf specifically.

The Washington Post was first to report that Biden was zeroing in on Califf earlier Thursday. 

“There has not been a decision made for the FDA commissioner and we remain grateful to the strong acting leadership at the FDA,” a White House official told The Hill when asked about reports the choice was likely to be Califf. 

White House press secretary Jen Psaki told reporters later Thursday that Biden is “eager” to make a decision but she added, “we’re just not quite at that point yet.”

Califf would take the helm of an agency that has not had a confirmed leader since Biden took office in January. The FDA is in charge of leading the nation through the eventual end of the COVID-19 pandemic, and it faces key decisions in authorizing COVID-19 booster shots and vaccines for children. 

Biden hinted last week that an announcement on his FDA nominee was imminent. 

“We’ll be talking about that in a little bit,” he told reporters last Tuesday when asked about his nominee for the agency after returning to the White House from a trip to Michigan.

Asked about the lack of a nominee and its impact on agency morale during a briefing earlier this week, Psaki said that Biden was focused on “nominating exactly the right person” for the job.

She also said that the FDA is full of “talented” career employees “who have moved forward on the approval of vaccines, the approval of boosters, the approval of, you know, a range of treatments that can help save lives in the public” without a confirmed leader in place.

Mark McClellan, who helmed the FDA under President George W. Bush, said Califf “would make an excellent commissioner.”

Lawrence Gostin, a global health law professor at Georgetown University, applauded Califf’s “impeccable scientific credentials” but raised concerns about his ties to the pharmaceutical industry and potential shortfalls in his experience. 

“Dr. Califf has most experience in academic medicine and has not led a major public health agency or been at the forefront of battles against infectious diseases,” Gostin said. “Overall, Dr Califf is a person of great stature and integrity, but he must be judged on making the FDA fiercely independent and especially on his leadership in the COVID-19 response.”

—Updated at 4:06 p.m.