Former US Food and Drug Administration (FDA) commissioner Robert Califf took to social media Tuesday as mass layoffs hit the top drug regulatory agency, saying, “The FDA as we’ve known it is finished.”
Several senior and mid-level leaders were ousted, along with thousands of staff. According to the White House last week, the total anticipated cuts were 3,500 at the FDA alone and nearly 20,000 across agencies.
Reflecting on the shake-up, Califf told Yahoo Finance in an interview that the relationship and stability that the agency provides the industry is going to be disrupted in the near term.
“It’s almost nonexistent because all the leaders are gone,” Califf said. “And a very large number of mid-level leaders are gone. In addition, all the very many people who helped with the communications work and interact in project management have been decimated by the firings.”
“So it’s going to have to be rebuilt,” he said. “That leads to unpredictability, which I know is a concern in the industry.”
Another former commissioner, Scott Gottlieb, who helmed the agency under Trump’s first presidency, also expressed frustration on social media. He reflected on how the agency had been pushing for reform over the years to give the US a leg up in drug research and not lag behind Europe.
“Today, the cumulative barrage on that drug-discovery enterprise, threatens to swiftly bring back those frustrating delays for American consumers, particularly affecting rare diseases and areas of significant unmet medical need,” Gottlieb wrote.
Califf said the attention should turn now to future plans.
“I think it’s a waste of time to try to think of the FDA the way it was, and now we turn our attention to construct an FDA which is going to get the job done,” Califf said. “For an administrative that proclaimed radical transparency, I haven’t seen transparency. No one I can find knows what to expect at this point.”
Califf has some reservations. He has read Project 2025, a white paper that surfaced as a potential roadmap for the Trump administration during the election cycle. That has been viewed as closely tracking the administration’s moves so far.
“I have read what’s been written in Project 2025, and I’ve also talked to many people who have been involved on the periphery, it really sounds like an effort to destroy the FDA,” Califf said.
The reduction in force is the second gut punch for the agency, creating alarm and uncertainty for the pharma and biotech industries.
