Politico - Biden nominates Califf as FDA chief

Adam Cancryn, David Lim, Alex Thompson, and Sarah Owermohle | November 12, 2021

President Joe Biden has nominated 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.

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.

“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.

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.

A cardiologist by training, Califf 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.

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 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.

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.

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‘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 planned 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."

Still, Califf is likely to face some opposition throughout the confirmation process over his own industry connections and role in the FDA’s past work on opioids.

Three Democrats — Sens. Joe Manchin of West Virginia, Richard Blumenthal of Connecticut and Ed Markey of Massachussets— voted against Califf in 2016 amid concerns about his ties to the drug industry and the FDA’s track record on opioids. Sen. Bernie Sanders (I-Vt.) also voiced objections, though he did not end up voting either way. Califf at the time had written papers with pharmaceutical industry executives and consulted for drug and device makers.

More recently, he has helped lead health policy at Google parent company Alphabet — a role that could draw further scrutiny from the Senate‘s left flank.

On Friday, Manchin vowed to oppose Califf again, calling his planned nomination “an insult to the many families and individuals who have had their lives changed forever as a result of addiction.”

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

Blumenthal has also signaled he would vote against him again — meaning Califf will need to win over at least a handful of Republicans to win confirmation.

“I would have very grave reservations about this nomination – many of the same reservations I expressed when I voted against Dr. Califf’s confirmation in 2016,” he said in a statement.

Katherine Ellen Foley contributed to this report.

https://www.politico.com/news/2021/11/12/biden-poised-to-nominate-califf-as-fda-chief-521060