Almost ten months into his presidency, Joe Biden has announced his pick to lead the US Food and Drug Administration (FDA). If confirmed by the Senate, the nominee, Dr Robert Califf, would become commissioner for a second time after leading the agency for almost a year at the end of the Obama administration.
President Biden described Califf as “one of the most experienced clinical trialists in the country” in a statement, arguing that the former commissioner has the experience and expertise to lead the FDA during a “critical time” in the country’s fight against the pandemic. Most recently, Califf worked as head of health policy at Google parent company Alphabet.
According to recent reports, the FDA has been “plagued by a series of missteps” in the past decade, “ranging from its approval of controversial drugs to its perceived bowing to political pressure,” that have undermined public confidence in it.
One of the main battles ahead of the agency will be balancing its own push to regulate e-cigarettes as to not interfere with the Biden administration’s plans to ban menthol-flavored tobacco products, along with vital decisions on coronavirus vaccines and treatments, as well as taking decisions on health tech challenges.
Uncertain Road to Confirmation
While the clinical trials experience described by President Biden is one of Califf’s major qualifications for the job, considering that the FDA oversees the drug approval process which has come under scrutiny in recent months, it is also a controversial section of his resume.
The former commissioner’s clinical trials involvement took place during his time at Duke University School of Medicine, where he graduated in 1978 and was later granted tenure as a professor of cardiology. He was the founding director of the Duke Clinical Research Institute, the world’s largest academic clinical research center.
As part of that role, Dr. Califf created extensive relationships with Big Pharma, “convincing them to do large, expensive, and, for Duke, profitable clinical trials,” according to Forbes.
His “close ties” have already become center stage of his Senate confirmation process, where he will need a simple majority (51 votes) in an evenly divided chamber. Already two Democratic senators have signaled their opposition to Biden’s pick, just as they did in 2016 when Barack Obama nominated Califf.
According to ProPublica, Califf was a paid consultant for MSD, Johnson & Johnson, GlaxoSmithKline, AstraZeneca, Roche, Amgen, Eli Lilly, among others, from 2009-2013.
“Dr Califf’s nomination makes no sense as the opioid epidemic continues to wreak havoc,” senator Jose Manchin said in a statement. “[His] nomination and his significant ties to the pharmaceutical industry take us backwards not forward.”
The Biden Administration, however, downplayed any concerns over Califf’s confirmation. “Every senator can vote for or against people who are nominated, that’s their role,” White House press secretary Jen Psaki said. “But we feel he is a qualified person who has the exact experience for this moment.” Back in 2016, then an Obama nominee, Califf was confirmed in an 89-to-4 vote.