Biden nominates Robert Califf to return as FDA head

President Joe Biden on Friday nominated former FDA head Robert Califf to return to the agency as its commissioner, choosing a familiar name to lead the regulator after a drawn-out search.

Califf, a cardiologist and prolific researcher, served as FDA commissioner for less than a year at the end of the Obama administration. After leaving government, he advised Google and its health spinoff Verily Life Sciences, taking a job leading health policy there in November 2019.

“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,” Biden said in a statement.

Biden’s choice was long awaited as he left one of the nation’s highest-profile public health roles unfilled for more than eight months, even as his administration made the U.S. response to COVID-19 its top priority.

Janet Woodcock, a longtime top agency official, has served as acting commissioner during the search process, and was at one point considered a leading contender for the position. But her role overseeing the FDA’s main drug review office as opioid overdoses became a nationwide epidemic drew criticism from lawmakers, as did the agency’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm under her watch.

In his statement, Biden said Woodcock “has done an incredible job leading the agency during what has been a busy and challenging time.” 

Woodcock can only serve as acting commissioner until Nov. 15 under federal rules, although she can continue in her role afterwards while the Senate considers Califf’s nomination.

Califf’s experience and familiarity with the agency will likely count in his favor, said Mark McClellan, an FDA commissioner during the early 2000s. “He has led the FDA, so he knows the agency and how to build on its strengths and address challenges from day one,” McClellan told BioPharma Dive in a recent email.

Confirmation still may not be smooth sailing in the Senate, though. In 2015 and early 2016, several Democratic senators delayed confirming him to the role over their anger with the FDA for its approvals of opioid painkillers. (Califf served as a deputy director at the agency before being nominated.)

He was ultimately confirmed as commissioner by an 89-4 vote.

A number of other candidates were floated as Biden’s commissioner, including former FDA leaders like Joshua Sharfstein as well as former Obama administration official Greg Simon. Also reportedly considered were Michelle McMurry-Heath, the CEO of the drugmaker lobbying group BIO, and medical academics like Dana-Farber Cancer Institute president Laurie Glimcher and Harvard Medical School’s Monica Bertagnolli.

The Washington Post first reported Califf was a leading candidate on Oct. 14. The Associated Press and The Wall Street Journal, among others, reported earlier on Friday that Biden had made his decision.

While Califf would have his hands full with the medical side of the FDA, there are also some big issues at play in food. Peter Lurie, president of the Center for Science in the Public Interest President and a former FDA deputy commissioner, said he hopes that if confirmed, Califf can fully remove politics from the agency.

“Job one will be to restore the agency’s reputation for scientific integrity — a reputation which took a considerable beating during the administration of Donald Trump,” Lurie said in a written statement. “This requires a commitment to high scientific standards and full transparency in agency decision-making. Besides restoring the primacy of science at the agency, to fully leverage their position the next Commissioner must be prepared to harness the role that food and nutrition play in advancing public health.”

FDA is getting close to issuing a major regulatory framework on 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, FDA and USDA issued a formal agreement that the agencies would jointly regulate the space, though 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 FDA opened a docket for comment on cell-based seafood labeling. No action has been taken so far, and USDA is at the end of a comment period on a similar docket for other cell-based meat products.

If confirmed, Califf could have the opportunity to finish the work on two major food labeling issues that he started but never saw completed in the almost five years since he led the department. In 2016, 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 USDA has come out with new parameters for the term, but there has been no publicly known progress from 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.

There are less controversial major actions around food that are pending before 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 in January. FDA’s fiscal year 2022 budget includes significant funds to work toward implementing this framework, and the department has been active in webinars and contests to promote it.

Although Biden was criticized for leaving the FDA without a permanent leader during a critical moment, the gap between confirmed commissioners is not unusually long by historical standards.

The FDA was without a permanent head for over a year after McClellan, President George W. Bush’s first appointee, resigned to lead the Centers for Medicare & Medicaid Services, for example. More than 10 months passed between Margaret Hamburg’s resignation and the start of Califf’s tenure during Barack Obama’s administration, and eight months elapsed between Scott Gottlieb and Stephen Hahn during Donald Trump’s presidency.