Biden Nominates Robert Califf to Lead FDA at Critical Juncture

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Word broke Friday morning that President Joe Biden was getting ready to nominate former U.S. Food and Drug Administration Commissioner Robert Califf to reprise his role at the agency’s helm. It is now official. 

"As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA. I am confident Dr. Califf will ensure that the FDA continues its science and data drive decision-making," Biden said in a written statement released by the White House late Friday morning. 

The news comes nearly a month after it was reported that Califf was being vetted for the top spot, and almost ten months after Janet Woodcock was named acting commissioner when Biden took office on January 20, 2021. While considered early on as a potential candidate for the permanent role, it has been widely assumed in recent months that Dr. Woodcock, who has come under fire for her support of the approval of Biogen Alzheimer's drug Aduhelm, would not stay in the role. The FDA approved the drug contrary to its overwhelming rejection by the agency’s advisory committee, sparking calls for Woodcock’s resignation. Her track record on opioids was also a sticking point for some members of the Democratic party.

Califf, well qualified for the job as a cardiologist and clinical trial specialist, served as FDA commissioner for the final 11 months of President Barack Obama’s second term in 2016/2017. Prior to that, he had a one-year stint in the FDA’s second spot. The bulk of Califf’s career has been spent at Duke University, where he specialized in designing studies for several pharmaceutical companies.  He has spent the past four years involved with the Duke Clinical Research Institute and has also served in an advisory role to Google – the tech giant whose parent company, Alphabet, owns DeepMind Technologies and recently launched AI startup Isomorphic Laboratories, which will focus on AI-driven drug discovery.

The search for a new commissioner culminates at a pivotal time in the nation’s battle against COVID-19, and just a week after President Biden announced a sweeping new vaccine mandate that would require private employers with more than 100 employees to ensure all employees are vaccinated by January 4, or implement stringent testing programs. If confirmed, Califf will be called on to help see the country through the remainder of the pandemic. After his previous nomination in 2016, Califf was confirmed by a vote of 89-4 in the Senate.

"I am honored to be nominated by President Biden for this position at a critical time for our country," Califf told CNN in a statement. "There's a lot of work to do, and if confirmed I look forward to rejoining the great team at the FDA to help in their inspiring mission to serve the public."

With strong bipartisan appeal, Califf would seem to be a safe choice, but he was apparently not the administration’s first. According to a source familiar with the selection process, Biden officials had sought a nominee who not only had the requisite FDA experience but was also considered a rising star in the field.

Candidates were considered from both industry and academia, including Biotechnology Innovation Organization CEO Michelle McMurry-Heath and Dana-Farber Cancer Institute President Laurie Glimcher. Joshua Sharfstein, another Obama-era official and vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, was also thought to be a potential candidate.