Biden nominates Califf as FDA chief

“Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic,” Biden said in a statement.

A cardiologist by training, Califf previously served as FDA commissioner for nearly a year at the tail end of the Obama administration — winning Senate confirmation by a wide margin despite the objections of a handful of Democratic senators.

The White House is counting on Califf to once again garner broad bipartisan support within the divided chamber, casting him as a deeply experienced researcher and policymaker who has long worked with both sides of the aisle.

Still, the 70-year-old will need to overcome pockets of resistance within his own party.

Sens. Joe Manchin of West Virginia and Richard Blumenthal of Connecticut — both of whom voted against Califf’s nomination in 2016 — have both signaled their opposition once again over concerns about his ties to the drug industry and the FDA’s track record on opioids.

“I have made it abundantly clear that correcting the culture at the FDA is critical to changing the tide of the opioid epidemic,” Manchin said in a statement. “Instead, Dr. Califf’s nomination and his significant ties to the pharmaceutical industry take us backwards not forward.“

Blumenthal separately said he had “very grave reservations about this nomination — many of the same reservations I expressed when I voted against Dr. Califf’s confirmation in 2016.”

Another opponent of Califf’s first stint as FDA commissioner, Sen. Ed Markey of Massachusetts, also issued a terse statement that highlighted his “serious concerns about the FDA’s efforts to curb this public health epidemic“ — though it did not say which way he planned to vote this time around.

Califf could also face increased scrutiny from the Senate’s left flank over his more recent role leading health policy at Google parent company Alphabet, as well as his leadership of a Duke University research center that received some funding from the pharmaceutical industry.

The White House on Friday downplayed any concerns over Califf’s ability to be confirmed.

“Every senator can vote for or against people who are nominated, that’s their role,” White House press secretary Jen Psaki said Friday. “But we feel he is a qualified person who has the exact experience for this moment.”

Califf’s candidacy is likely to be buoyed by endorsements from a range of public health experts who have urged Biden for months to settle on a nominee.

Cytokinetics CEO Robert Blum told POLITICO that Califf‘s 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 need to 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.”

Califf’s nomination also won immediate praise from some influential advocacy groups that have worked closely with the FDA. They hailed the selection as one that would bring long-sought stability to an agency that’s spent the last two years under intense pressure.

“Robert is unquestionably qualified to lead the FDA during these unpredictable times,” said Ellen Sigal, chair of Friends of Cancer Research, adding that he should “receive strong bipartisan support in the Senate.”

Steven Grossman, executive director of the Alliance for a Stronger FDA, noted serving as commissioner early in a presidency allows Califf with a greater opportunity to exert influence over the policy direction of the FDA than his short stint under Obama.

“If confirmed, I would expect Dr. Califf to examine the agency more broadly and address priority needs more resolutely than in his prior stint,” Grossman said. “The current situation is very different from being commissioner in the seventh and eighth year, when the White House is less interested and the time frame for changes is quite limited.”

Biden‘s selection of Califf came more than nine months into a presidency so far defined by the pandemic response and Covid-19 vaccination campaign, and as his administration ran up against a Nov. 15 deadline to name a permanent FDA nominee.

Acting Commissioner Janet Woodcock, who has led the agency in the interim, will remain in charge through Califf’s confirmation process, an HHS spokesperson said.

Califf was not originally the White House’s top pick. He emerged as Biden’s choice in recent weeks after the administration had vetted or spoken to roughly a dozen other people about the job, according to a person familiar with the selection process.

As early as last winter’s presidential transition, the administration had considered nominating 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.

Biden officials spent the next several months seeking a nominee who had both the requisite FDA experience and was also considered a rising star in the field, the person familiar with the selection process said.

But some of those the administration considered were not interested in running the agency; others were ruled out over their industry ties or other financial entanglements, the person said. Among those that Biden’s team looked at were Biotechnology Innovation Organization CEO Michelle McMurry-Heath and Dana-Farber Cancer Institute President Laurie Glimcher.

The White House turned its focus to Califf in early September, nearly nine months into Biden’s presidency and with only weeks to go until a statutory deadline for nominating a permanent commissioner.

He quickly emerged as the leading candidate, driven in large part by preexisting knowledge of the agency’s inner workings and a bipartisan appeal that made him a consensus pick within the administration. In addition to his earlier stint as FDA commissioenr, Califf 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.

Califf confirmed his nomination in a statement, saying he is “honored to be nominated by President Biden for this position at a critical time for our country.“

“There’s a lot of work to do, and if confirmed I look forward to rejoining the great team at the FDA to help in their inspiring mission to serve the public,” he said.

Katherine Ellen Foley contributed to this report.