After a drawn-out period of uncertainty, a familiar candidate has emerged to serve as commissioner of the Food and Drug Administration: Robert Califf, who held the same role between February 2016 and January 2017.
Califf currently heads clinical policy and strategy at Google’s research organization Verily Life Sciences. If nominated and confirmed, he would replace acting commissioner Dr. Janet Woodcock, who has served in the post since January.
Califf’s nomination is not set in stone, according to The Washington Post, which first reported the news.
Terry Haines, founder of healthcare policy consultancy Pangaea Policy, noted that Califf amounts to a safe candidate, with his known-commodity status likely to bolster his credibility. That said, Haines doesn’t believe that the confirmation process will be a cakewalk.
Califf has been characterized by Democrats and consumer advocacy group Public Citizen alike as a “recycled” pick with too-close ties to the pharma industry. Califf’s close association with Google might also be viewed as a drawback.
“It’s a very different situation in 2021 compared to 2016,” Haines explained. “Califf being trashed as a friend of pharma and part of these big tech companies – those are two difficult hurdles.”
The potential nomination arrives at a moment when the FDA is staring down a large amount of uncertainty. The agency recently faced criticism around its rollout of booster shots and its controversial approval of Biogen’s Alzheimer’s drug Aduhelm. Additionally, reports of staff burnout have proliferated in recent months.
While Woodcock was considered a relatively stable choice as acting commissioner, she didn’t have as much clout addressing these issues as a permanent commissioner would, according to Coalition for Healthcare Communication executive director Jon Bigelow. Other looming items on the to-do list include clearing the air on the accelerated approval process, appropriate messaging around COVID-19 approvals and finalizing Prescription Drug User Fee Amendments (PDUFAs).
In short, the arrival of a permanent commissioner could do wonders for the FDA, which is perceived to have faltered in recent years.
“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,” Bigelow said. “There’s still a lot of settling of the waters to be done.”
Biden is expected to make his final decision before the White House’s legal deadline of November 15.