President Joe Biden is considering nominating former FDA Commissioner Robert Califf to once again lead the agency, according to multiple reports citing unnamed sources familiar with the process.
The administration's search for a nominee to run the agency has now stretched nearly nine months, even as the public health response to the coronavirus pandemic remains a top priority of the White House.
Janet Woodcock, a longtime top agency official, has served as interim commissioner since January, and was at one point viewed as a leading contender for the position. But her role running the FDA's main drug review office as opioid overdoses became an epidemic has drawn criticism from lawmakers, as did the agency's controversial approval of Biogen's Alzheimer's drug under her watch.
The Washington Post first reported the administration was "closing in" on Califf in a story Thursday, citing unnamed sources.
White House Press Secretary Jen Psaki said during a Thursday press briefing that Biden has not yet made a decision on who he will nominate.
"The President is definitely eager to make a decision about an FDA nominee, and of course make that decision public once it's made," Psaki said. "We're just not quite at that point yet."
Califf served as the FDA commissioner from February 2016 to January 2017 at the end of the Obama administration. He was confirmed by a vote of 89-4 but still faced criticism for his connection to pharmaceutical companies. At the time, a number of Democratic senators also expressed concerns about the FDA's approach to regulating opioids.
If nominated, the former commissioner may face similar opposition from some of the same Senate Democrats who voted against him in 2016. Three of the four — Joe Manchin of West Virginia, Ed Markey of Massachusetts and Richard Blumenthal of Connecticut — still serve in the Senate.
Since leaving government, Califf's ties to industry have strengthened, as he consulted for Google and later joined the leadership team of Google's spinout healthcare company Verily.
Between 2014 and 2020, Califf received over $93,000 in payments from multiple drugmakers, including Merck & Co., AstraZeneca, Eli Lilly and Amgen, according to the Centers for Medicare and Medicaid Services' Open Payments Database. The payments were predominately consulting fees.
Califf, a cardiologist and researcher, is also a professor at Duke University.
Analysts at Cowen wrote that Califf "would be a victory for supporters of the status quo at the agency when it comes to the overall approach to new drug reviews and interactions with industry," adding that "there is little reason to believe he would not be comfortably supported this time around."
At least one group, however, has already voiced opposition to Califf, should he be Biden's pick. "The country desperately needs an FDA leader who will reverse the decades-long trend in which the agency's relationship with the pharmaceutical and medical-device industries has grown dangerously cozier ... Califf would not be that leader," Michael Carome, of the advocacy group Public Citizen, said in a statement.
Ned Pagliarulo contributed reporting.