FDA commissioner nominee Califf makes ethics pledge to Warren in bid for her support: report

With Robert Califf's FDA nomination facing Senate headwinds, the Obama administration-era chief has made an ethics pledge to win a key vote, according to Politico.

After his stint as FDA commissioner—assuming he gets the gig—Califf has agreed to a four-year break from employment or payment from any drugmaker or medical device company he crosses paths with in office, Politico reports, citing a letter he sent to Sen. Elizabeth Warren.

Concerns over Califf’s handling of the opioid crisis and his ties to the biopharma industry have made the nomination for his second FDA tenure anything but a slam dunk. He recently moved forward in his confirmation process, thanks to a 13-8 vote by the Senate Committee on Health, but lawmakers on both sides of the aisle have voiced reluctance about the nomination.

Five democrats in the evenly divided Senate have telegraphed plans to oppose the Biden administration nominee, while only four republicans have publicly backed Califf’s candidacy, Politico notes.

Thanks to Califf’s post-FDA concessions, he can now count Warren among his supporters. A spokesperson for the Massachusetts Democrat told Politico that Warren would back Califf if his nomination ultimately hinged on a vote.

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Califf has also consented to a four-year period during which he won’t participate in FDA decisions linked to companies he’s had relationships with, up from an original recusal period of two years. In 2019, Califf joined Google's parent, Alphabet, to help lead health policy at Google and the work of its sister company, Verily. Meanwhile, Califf joined the boards of Cytokinetics and Centessa Pharmaceuticals following his two-year run as commissioner. 

“The Biden-Harris administration has set the highest ethical standards of any administration for its political appointees,” Califf wrote in his letter, as quoted by Politico. “However, in response to your letter, I am willing to voluntarily extend the recusal period from two years to four years for all particular matters involving companies with which I have a previous working relationship.”

Beyond that, he won’t be involved in any FDA matters linked to Duke University. Califf was a professor of cardiology and medicine at Duke University, as well as the founding director of the Duke Clinical Research Institute. Califf retired from the university in 2019.

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Warren met with Califf earlier this month and asked him to “sign on to ethical standards that go beyond the administration’s high standards, and he agreed,” a Biden administration official told Politico.

Warren and several other Democrats were troubled by the $2.7 million paycheck Califf snagged from Verily Life Sciences, where he serves as a senior advisor, according to the company’s website.

At the Senate Committee on Health meeting earlier this month, Democratic Sen. Maggie Hassan and independent Sen. Bernie Sanders voted against his nomination, with Sanders citing Califf’s “revolving door” ride from the industry to the FDA.

The FDA has now gone more than a year without a permanent leader. Califf, for his part, won the nomination back in October.

In February 2015, during the waning years of Barack Obama’s presidency, Califf was appointed deputy commissioner. He served as full commissioner from February 2016 to January 2017. His first confirmation went much smoother than this time around. For that run, Califf passed the full Senate by a vote of 89-4.