The U.S. Senate on Tuesday voted to confirm Robert Califf as commissioner of the FDA, filling a position that had remained vacant for more than a year despite the agency playing a leading role in the nation's response to the COVID-19 pandemic. The final vote was 50-46 in favor of Califf's confirmation.
Republican support proved crucial for President Joe Biden's nominee, as a group of Democrats opposed Califf over the FDA's approval of opioid painkillers during his first stint as FDA commissioner and deputy, as well as over his ties to the pharmaceutical industry.
"He's the leader we need today, but also for the future," Sen. Richard Burr, R-N.C., the senior Republican on the Senate Health, Education, Labor and Pensions Committee, said before the vote. "There's never been a more critical time for the FDA to have effective leadership." Five other Republicans joined 43 Democrats and independent Sen. Angus King of Maine in voting for Califf.
Sen. Joe Manchin, D-W.Va., led Democratic opposition to Califf, forcefully arguing that the agency's stance on opioids would not change under Califf.
"This administration under Dr. Califf will take the same-old same-old policies as before," he said.
Now confirmed, Califf will take the reins as the agency's 25th commissioner with a long agenda in front of him. The FDA has been led on an interim basis by Janet Woodcock, formerly the head of the agency's drug review division and at one point viewed as a likely candidate for Biden's nomination. However, a permanent chief will have more authority to set far-reaching policies, even though Woodcock has considerable influence at the agency.
Woodcock, in an email to FDA staff, said she will serve as "principal deputy" to Califf during the transition.
While the medical side of the FDA dominated debate over Califf's confirmation, the new commissioner has several big issues in food regulation coming under his purview — including many labeling matters that have been pending for years.
Califf will preside over the department as it works toward regulations for cell-based meat. Several companies have been working toward using cell cultures to grow meat, but it cannot be sold or served until the federal government can ensure it is safe — as well as set down rules for how these products can be labeled and marketed. In March 2019, the FDA and USDA issued a formal agreement that the agencies would jointly regulate the space, though the FDA will solely regulate cell-based seafood because of jurisdictional issues. While much of the work toward a regulatory framework has been going on out of public view, last year the FDA opened a docket for comment on cell-based seafood labeling. At the end of last year, the USDA also received comments on a similar docket for other cell-based meat products. No proposed regulations have been issued yet.
There is also the lack of a federal regulatory framework for CBD and cannabis-infused food and beverages, even as manufacturers debut new products and invest in R&D in preparation for any developments.
Califf will also have the opportunity to finish the work on two major food labeling issues that was started during the Obama administration, but have not yet been completed. In 2016, the FDA announced it would work toward redefining the term "healthy" for food labeling purposes. There was a public hearing on the issue in 2017, and the USDA has come out with new parameters for the term, but there has been no publicly known progress from the FDA.
Another commonly used — but undefined — labeling term is “natural.” The term has been the basis of countless lawsuits and consumer actions because there is no consensus on what it means. The agency put out a press release trying to explain natural and artificial flavors in 2016, which some thought could be a precursor to an official action to set a definition. Nothing further has come out of the department since then.
But there may also be coming action on other controversial labeling issues that haven't seen much action lately. The National Milk Producers Federation put out a statement cheering Califf's confirmation, hopeful that he will use his powers to target plant-based products using dairy terminology on their labels. At Califf's confirmation hearing, he responded to a question about the issue from Sen. Tammy Baldwin, D-WI, by saying there is "almost nothing more fundamental about safety than people understanding exactly what they’re ingesting, so I am committed to making this a priority if I am confirmed.”
There are less controversial major actions around food that are pending before the FDA. The department is working toward implementing the New Era of Smarter Food Safety, a 10-year blueprint to improve the system through better traceability, predictive analytics and quicker response rates. This framework was announced last year during the Trump administration, and it has been a priority since President Biden took office.
Food industry groups released statements on Tuesday citing their eagerness to work with Califf.
"As we have seen throughout the COVID-19 pandemic, strong leadership and clear guidance from the FDA is essential to the success of the consumer packaged goods industry," Roberta Wagner, Consumer Brands Association vice president of regulatory and technical affairs, said in a written statement. "We are pleased to see the Senate has confirmed Dr. Califf and look forward to continuing a productive relationship with the FDA under his leadership.”
Califf served as FDA commissioner in the final year of President Barack Obama's administration, when he was elevated from a position as deputy commissioner. Lawmakers raised objections over opioid policies then, too, but his confirmation was cleared by a much more decisive 89-4 vote.
This time around, there was more sustained opposition, drawing out the nomination process over three months. Manchin and Sen. Mike Braun, R-Ind., even wrote an op-ed in USA Today against Califf, noting the FDA approved five opioids while he was commissioner in 2016 and 2017.
Backing Califf, on the other hand, were former FDA commissioners Scott Gottlieb, Margaret Hamburg and Mark McClellan, who, along with former Medicare chief Andy Slavitt, pointed out in an op-ed in The Hill that Califf helped design trials aimed at preventing and treating opioid addiction.
Before joining the FDA, Califf was a cardiologist and researcher at Duke University who was known for his contribution to modernizing clinical trial design. After leaving the FDA the first time, he advised Google and joined its life sciences spinoff Verily as a health policy expert.
Note: This story has been updated for publication on Food Dive, with additional details added throughout.