Califf as FDA chief

Biden poised to nominate Califf as FDA chief

The move would bring the Obama-era official back for a second tour atop the agency.

By ADAM CANCRYN, DAVID LIM, SARAH OWERMOHLE and KATHERINE ELLEN FOLEY

President Joe Biden is expected to nominate former Commissioner Robert Califf to lead the Food and Drug Administration Friday, in a move that would bring the Obama-era official back for a second tour atop the agency, two sources familiar with the announcement told POLITICO.

The selection would end the administration's lengthy search for a permanent FDA commissioner and comes as the agency weighs a series of decisions that will determine the direction of Biden's Covid-19 vaccination campaign.

If confirmed by the Senate, Califf would also play a key role in charting the government's wider pharmaceutical and tobacco policy ambitions — as well as managing growing scrutiny of the FDA's drug approval process.

The White House has not responded to multiple requests for comment. Attempts to reach Califf were unsuccessful.

Califf, a cardiologist by training, previously served as FDA commissioner for nearly a year at the tail end of the Obama administration. He also spent two years as deputy commissioner of the FDA's medical products and tobacco office and worked closely with Biden on the then-vice president's Cancer Moonshot Initiative.

He emerged in recent weeks as the White House's top candidate to run the FDA, driven in large part by his preexisting knowledge of the agency's inner workings and bipartisan appeal.

Califf garnered broad support during his first stint as FDA commissioner, winning confirmation by an 89-4 margin. This time around, he's likely to be buoyed by endorsements from a bipartisan group of fellow former FDA commissioners — as well as public health experts who have urged Biden for months to settle on a nominee.

Cytokinetics CEO Robert Blum told POLITICO that Califf personality and track record is well suited to the moment, describing him as someone who "commands a lot of respect" despite an often low-key demeanor. Califf joined Cytokinetics' board of directors in February 2018, a position he will likely step down from.

"He is somebody who is deeply interested in clinical evidence and basically built his career around it," Blum said. "Rob understands the appropriate proper interplay between the private sector and the public sector, both in terms of science, industry and regulatory matters. He's certainly not a shill for any one stakeholder. He demonstrated that when he was already at FDA."

Despite the agency’s prominent role in the Covid-19 response, it has been without a permanent leader since Biden took office. The White House had originally considered nominating longtime regulator and acting Commissioner Janet Woodcock to the role. But her candidacy stalled in the face of Democratic opposition over her track record on opioids and a more recent decision to green-light a controversial Alzheimer's drug.

"It's a very unorthodox thing that he would be himself asked to go back, but he's a quite uncommon person," Blum said. "I don't know if that's the case for a lot of other people where they would choose to go back like that. I think he's got a real call to duty right now, given the politicization of what's happening around Covid and other things."

Several other candidates — including Biotechnology Innovation Organization CEO Michelle McMurry-Heath and Dana-Farber Cancer Institute President Laurie Glimcher — were also considered and eventually ruled out during the wide-ranging, nine-month search process.

Still, Califf could face questions of his own. In addition to working at the Duke Clinical Research Institute, he has helped lead health policy at Google parent company Alphabet since 2019 — a role that may draw scrutiny from the Senate’s left flank.

Sens. Joe Manchin (D-W.Va.) and Sen. Bernie Sanders (I-Vt.) also voiced concerns about Califf during his confirmation process in 2016, with both questioning his ties to the drug industry. Califf at the time had written papers with pharmaceutical industry executives and consulted for drug and device makers.

Yet in the run-up to Califf's official nomination, several outside health experts hailed his selection as one that would bring long-sought stability to an agency that's spent the last two years under intense pressure.

“From the perspective of fulfilling FDA's tobacco mission, Dr. Califf would be a superb choice," Campaign for Tobacco-Free Kids President Matthew Myers told POLITICO, saying the former commissioner has a record of encouraging the agency to take "strong action to reduce tobacco use.”