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Biden nominates one-time FDA commissioner Robert Califf to run the agency again

November 12, 2021, 3:24 PM UTC

Robert Califf is expected to be nominated Friday by President Joe Biden to run the U.S. Food and Drug Administration, according to two people familiar with the process. The move would put a one-time commissioner back at the health agency’s helm in the midst of a still-raging pandemic.

Califf, a doctor and widely published scientist, is currently head of clinical strategy and policy at Alphabet Inc.’s Verily and Google Health units. He previously served as FDA commissioner during the final year of the Obama administration.

If confirmed by the Senate, he would take the place of acting FDA Commissioner Janet Woodcock. Califf’s first appointment to lead the FDA was approved in an 89-4 vote in 2016.

The selection would put a permanent leader in charge of the vast regulator for the first time since Biden took office. Woodcock has steered the FDA’s day-to-day operations through some of the most tumultuous moments of the coronavirus pandemic, but the White House signaled months ago she wouldn’t be in line for the top job.

Califf will be faced with an imposing to-do list if he returns to his old post. The FDA continues to be a central player in the pandemic response. At the same time, it is reviewing thousands of vaping products amid lingering concerns over their potential to addict new users to nicotine, navigating a thorny controversy over the approval of an Alzheimer’s disease drug some former advisers say shouldn’t have been allowed on the market, and facing questions about its capacity to oversee the safety of the global drug supply chain.

“Robert is unquestionably qualified to lead the FDA during these unpredictable times,” said Ellen Sigal, chair of Friends of Cancer Research. “He has always been a strong proponent of science, patient safety and innovation and should receive strong bipartisan support in the Senate.”

Big steps

The agency has taken significant steps to provide front-line health workers with tools to battle COVID-19. It has cleared three vaccines and is on the cusp of broadening access to them to younger children. It has also authorized new treatments such as monoclonal antibodies and remdesivir to fight infections, and is set to consider a new antiviral pill in coming weeks.

In his previous turn as commissioner, Califf took on the early stages of extending the FDA’s oversight of tobacco to include electronic cigarettes, as well as its response to the opioid addiction and overdose crisis. 

Howard Sklamberg, a deputy commissioner under Califf, described him as an “avuncular, pleasant person” who sets direction rather than micromanages.

“All the center directors liked him, which is not always true with commissioners and center directors,” said Sklamberg, who is now an attorney at Arnold & Porter.

Trained cardiologist

A cardiologist by training, Califf is a prolific researcher with more than 1,200 publications in peer-reviewed literature. That work drew questions from some lawmakers who were worried about his ties to the industry he’d be regulating when he was nominated by Obama. 

Skalmberg said Califf took care to avoid conflicts as commissioner. Califf kept a whiteboard in his office that listed all the projects he couldn’t work on, Sklamberg said, and “was very, very, very careful” about recusing himself.

After leaving the FDA, Califf initially split his time between Duke University, where he was a longtime professor and vice chancellor and earned his medical degree, and Google’s Verily. He then moved to Silicon Valley to become the head of clinical policy and strategy for Verily and Google Health.

He is one of several former commissioners who called to make the FDA a more independent agency from the Department of Health and Human Services to shield it from political influence.

—With assistance from Justin Sink.

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