Robert M. Califf, MD, today became the second former FDA commissioner to win U.S. Senate confirmation a second time, as senators narrowly approved his returning to the position he held for most of the final year of President Barack Obama’s administration. [FDA]

Robert M. Califf, MD, today became the second former FDA commissioner to win U.S. Senate confirmation a second time, as senators narrowly approved his return to the position he held for most of the final year of President Barack Obama’s administration.

The Senate approved President Joe Biden’s re-nomination of Califf by a 50–46 vote, the narrowest margin of any confirmed commissioner in the agency’s 115-year history. Six Republicans joined the Democratic majority, while four Democrats and Bernie Sanders (I-VT) voted against. Sen. Mike Rounds (R-SD) voted present, while Sen. Ben Lujan (D-NM), who has suffered a stroke, did not vote.

Califf becomes the second FDA commissioner to serve two stints at the agency’s helm. The first was Walter G. Campbell, who served from 2021–24 and from 1927–44—under four U.S. presidents, from Warren G. Harding through Franklin D. Roosevelt.

Biden, who served as Obama’s vice president, re-nominated Califf in November.

During his confirmation hearing before the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP), Califf summarized his priorities as “emergency preparedness and response; consumer and patient protection; and modernization and innovation.”

“When it comes to emergency preparedness and response, the FDA must continue to be a strong partner in battling COVID-19. And, it must have infrastructure in place that reflects lessons learned from this pandemic so it is ready for the next one,” Califf testified on December 14. “Secondly, all FDA’s actions regarding the products the agency regulates must focus on protecting consumers and patients. Safety matters.”

Califf also called for the FDA to improve how it generates and acts upon postmarket or “real-world” evidence on the performance of drugs that advance through clinical trials and receive approvals or emergency authorizations.

At the FDA, Califf will succeed Janet Woodcock, MD, a veteran of the agency who has served as its acting commissioner since the departure of Stephen M. Hahn, MD, the second of two commissioners who served under Donald Trump. His first commissioner, Scott Gottlieb, MD, was confirmed in 2017 by what was until today the narrowest margin in agency history, 57–42.

After breezing through his first nomination, winning Senate confirmation by an 89–4 Senate vote, Califf succeeded Obama’s first FDA commissioner Margaret Hamburg, MD, who served from 2009–2015. When Trump succeeded Obama as president in 2017, Califf resigned and returned to the Duke Clinical Research Institute (DCRI), which he founded in 2006, with a new appointment as the Donald F. Fortin professor of cardiology.

Two years later in 2019, Califf joined Alphabet-owned Google Health and Verily Life Sciences as a senior advisor.

Califf spent 33 years with Duke University School of Medicine and the Duke University Medical Center, most notably as its vice chancellor of clinical and translational research before founding DCRI, and before joining the FDA in 2015 as its deputy FDA commissioner for medical products and tobacco.

Sanders and the Democrats who voted against Califf chiefly cited objections to the agency’s response to the opioid epidemic during his first tenure at the FDA’s helm, as well as his ties to biopharmaceutical companies. Democrats opposing Califf’s reconfirmation included Richard Blumenthal (CT), Maggie Hassan (NH), Joe Manchin (WV), Ed Markey (MA), and Elizabeth Warren (MA).

“Given the dire situation facing our communities, it makes absolutely no sense to install a candidate who has already led the FDA in its most senior position but failed to address [the opioid] crisis in any meaningful way,” Manchin and Sen. Mike Braun (R-IN) wrote in a February 11 commentary published in USA Today. “We need new, dedicated leadership that understands the gravity of the drug epidemic and will fight back against the greed of the pharmaceutical industry.”

Califf tried to persuade Warren by promising not to seek employment or compensation for four years from any biopharma or medical device developer with which the agency would interact during his second tenure. He made a similar pledge, but only for two years, when he pursued the FDA commissioner position in 2015–16.

Today, Califf lost the votes of 20 Republican Senators who voted for his first confirmation as FDA commissioner—including Senate Minority Leader Mitch McConnell (KY) and Assistant Republican Floor Leader John Thune (SD). Republican objections to Califf focused on his past support for access to abortion drugs, and his support for the FDA’s recent decision to permanently allow such drugs to be available by mail order.

“With a track record of rubber-stamping abortion industry demands and with permanent authorization of unsafe mail-order abortion hanging in the balance, Califf is the wrong choice for FDA Commissioner,” leaders of six organizations opposing abortion rights wrote in a January 12 letter to Senators.

Six Republicans who crossed the proverbial aisle to vote for Califf included Roy Blunt (MO), Richard Burr (NC), Susan Collins (ME), Lisa Murkowski (AK), Mitt Romney (UT), and Pat Toomey (PA). The six joined Democrats yesterday in ending debate on Califf’s reconfirmation through a procedural vote.

“It has been 391 days since the FDA has had a Senate-confirmed Commissioner,” Burr said in remarks made on the Senate floor earlier today. “No matter how effective and successful an acting Commissioner may be, and we’ve been blessed with Janet Woodcock’s leadership, the full backing of a Presidential nomination and confirmation by the United States Senate carry a weight that allows a confirmed Commissioner to push forward necessary, meaningful change and leadership within a federal agency.”

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