Califf Wins Second Act as FDA Boss in Narrow Senate Vote

Robert Califf_Mescape

Dr. Robert Califf/courtesy

Robert Califf is taking up the mantle of FDA Commissioner for a second time.

After a filibuster was broken Monday, the Senate confirmed Califf’s nomination in a 50-46 bipartisan vote. Six Republicans supported Califf’s nomination, while several Democrats, including Sen. Joe Manchin of West Virginia, voted against the nomination.

Califf previously served as commissioner of the U.S. Food and Drug Administration during the administration of President Barack Obama. A cardiologist by training, Califf held the role from February 2016 to January 2017. Current President Joe Biden, who served as vice president under Obama, tapped Califf for the role in the fall of 2021 as acting Commissioner Janet Woodcock’s temporary time in the role was running out. In contrast to the narrow confirmation today, Califf was previously confirmed 89-4, with strong bipartisan support.

“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. I am confident Dr. Califf will ensure that the FDA continues its science and data-driven decision-making,” Biden said in a statement when he nominated Califf back in the fall.

Califf had some opposition for a return to the role due to his ties to the pharmaceutical industry, as well as the mounting opioid epidemic during his previous stint as FDA Commissioner. Manchin, a Democrat from West Virginia, was strongly opposed to Califf on those grounds. He suggested a change in the culture of the FDA was warranted and that Califf would not allow that to happen.

Sen. Richard Burr, the top Republican on the Senate's Health, Education, Labor and Pension Committee, took to the Senate floor this afternoon to tout Califf’s capabilities. He said the former FDA commissioner has the “robust agency and private sector experience” to guide the agency and help the country return to a sense of normalcy following the COVID-19 pandemic.

COVID-19 will certainly be a top priority for Califf as he takes the reins of the FDA. Although infection rates have been falling and some mitigation practices are being eased, there are new variants recently discovered in South Africa that could become an issue in another wave of infections.

In addition to COVID-19, Califf will also be dealing with concerns over the FDA’s accelerated approval program. During his nomination hearing last month, Califf noted that he was a fan of accelerated approval under the right conditions.

“The very fact of [the] accelerated pathway means that we’re accepting that there’s more uncertainty and the FDA has tremendous latitude about the decision it makes with those pathways, and that means we’ve got to have a better system to evaluate these products as they’re used on the market,” Califf said during the hearing, according to the Regulatory Affairs Professionals Society.

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