The Senate narrowly confirmed Dr. Robert Califf, a cardiologist and biomedical scientist, to lead the Food and Drug Administration, with several Republicans crossing the aisle to make up for Democratic dissent.
Califf was confirmed by a vote of 50-46, with support from such Republicans as Mitt Romney of Utah, Mitch McConnell of Kentucky, and Richard Burr of North Carolina, compensating for the “no” votes from a handful of Democrats. The Democrats who opposed the confirmation have cited Califf’s ties to the pharmaceutical industry as well as his handling of the opioid crisis during his previous tenure atop the agency during the Obama administration.
“What started as an OxyContin prescription for back pain became full-blown dependence on heroin for countless Americans,” Massachusetts Democrat Ed Markey said on Tuesday. “The FDA continued to approve powerful new opioids either over the express objections of its own advisory committees or without convening an advisory committee at all. The FDA became the country’s biggest pill pusher [and] Big Pharma made billions in profits.”
Markey was one of the “no” votes on the Senate floor Tuesday.
“We cannot forget how we reached this epidemic in the first place, or we are doomed to repeat it for those families,” Markey said. “Those failures started at Big Pharma and were aided and abetted by the Food and Drug Administration.”
Sen. Joe Manchin, a centrist West Virginia Democrat, has proven one of the most outspoken opponents of Califf’s nomination. Manchin has railed against the pharmaceutical industry for its role in perpetuating the epidemic of opioid addiction as well as the FDA’s perceived complicity with regard to approving addictive drugs for public use.
“We have insight into how he will lead the agency. [During] Dr. Califf’s previous tenure, drug-related overdoses went up. Five years later, they’re up again, and this time at record numbers,” Manchin said on Monday. “In fact, despite his pledge to overhaul the FDA policy, during his tenure and immediately following it, the FDA approved five new opiates for the market, and at the same time, they removed only one.”
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Manchin also voted against Califf’s nomination to head the FDA under former President Barack Obama. He was confirmed by an 89-4 vote. In a cloture vote on Monday to advance his nomination for a full floor vote on Tuesday, Califf was approved by a vote of 49-45. Four Democrats voted against him — Manchin, Markey, Richard Blumenthal of Connecticut, and Maggie Hassan of New Hampshire — as well as independent Bernie Sanders of Vermont, who caucuses with the Democrats.
“The wise Dr. Maya Angelou famously said, ‘When someone shows you who they are, believe them.’ Well, Dr. Califf has shown us who he is, and he has shown a complete lack of interest in actually making the difficult decisions that we need the leader of the FDA to make,” Manchin said Monday.
Other Republicans who opposed Califf’s nomination have cited concerns over his leniency with making medication-induced abortions easier to access. The Biden administration permanently lifted dispensing requirements for the two-drug abortion-inducing medication in December, making it possible for women to be given a prescription via telehealth appointments and receive the drugs in the mail. For instance, Montana Republican and outspoken abortion opponent Steve Daines said on Tuesday that Califf “has refused to distance himself from the FDA’s decision to abandon vulnerable pregnant women to the reckless and predatory actions of the abortion industry.”
Califf is a professor of medicine in the Division of Cardiology at Duke University, as well as a practicing cardiologist. He has also had a long career in medical research at Duke and is one of the most frequently cited authors in biomedical science, with over 1,200 peer-reviewed publications. But his ties to Big Pharma have alienated Democrats.
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He was paid as a consultant for pharmaceutical companies Merck, Johnson & Johnson, and GlaxoSmithKline from 2009 to 2013. After serving as FDA commissioner from 2016 to 2017, he became the head of medical strategy and policy at Verily, Google’s health sciences arm.
Califf will inherit a post at an agency that has struggled to regulate e-cigarettes and authorize COVID-19 vaccines and tests. The position was filled temporarily by Dr. Janet Woodcock, but there had not yet been a permanent commissioner under the Biden administration.
