After months of uncertainty over Food and Drug Administration leadership, President Biden will formally nominate Robert Califf as commissioner.
Califf previously served as FDA commissioner from February 2016 to January 2017. Currently he leads clinical policy and strategy at Google’s research organization Verily Life Sciences.
Califf emerged as Biden’s top candidate for the role back in October, ahead of acting FDA commissioner Dr. Janet Woodcock. Though Woodcock had initially been viewed as close to a shoo-in for the job, some Democrats publicly questioned her perceived link to the opioid epidemic.
News of Califf’s expected nomination comes just three days before the White House’s legal deadline of November 15.
The drawn-out wait for a permanent commissioner caused its share of headaches, especially as the FDA struggled to maintain its apolitical reputation during the pandemic.
“It would be an excellent move to get a permanent nominee in place, because time is passing and the FDA is not able to take the public-facing role that it should be taking in the midst of the pandemic,” Jon Bigelow, executive director of the Coalition for Healthcare Communication, said at the time.
Reports of staff burnout and the controversial approval of Biogen’s Alzheimer’s drug Aduhelm have further beleaguered the agency. It has also grappled with an extensive backlog of biopharma inspections, which could lead to delays in drug applications and consumer safety issues.
While Califf is generally seen as a safe choice for commissioner, his confirmation isn’t a given. The consumer advocacy group Public Citizen, among others, have characterized him as a “recycled” pick and argued that he’s too closely tied to the pharma industry.
If confirmed, Califf will play an integral role in the Biden administration’s next steps in the COVID-19 vaccination campaign, as well as the federal government’s broader drug approval and health-adjacent policy goals.