“The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed,” former FDA Commissioner Dr. Robert Califf said on LinkedIn, calling it “a dark day for public health.”
“I believe that history will see this a huge mistake,” he continued, noting he’s been and noting he’s been “overwhelmed with messages about the firings.”
“I will be glad if I’m proven wrong, but even then there is no good reason to treat people this way,” Califf said. “It will be interesting to hear from the new leadership how they plan to put Humpty Dumpty’ back together again.”
Previously: Califf weighs in on Trump’s election as he plans his own exit: ‘Stand by the people’
HHS previously said FDA inspectors and drug, medical device and food reviewers will not be affected by the cuts, but Barron’s reports the terminations include Dr. Peter Stein, the longtime head of FDA’s Office of New Drugs.
“The loss of staff with huge experience, dedication, and expertise — in essential roles — will undermine critical functions at FDA,” Stein told the publication. “It’s hard to imagine more foolish, poorly considered, and thoughtless actions—actions that will hurt Americans.”
The cuts also included at least four directors of the NIH’s 27 institutes and centers and “nearly entire communications staffs,” according to the Associated Press, which also reported “extensive layoffs in programs that track asthma, air pollution, smoking, gun violence, reproductive health, climate change and other health threats” at the CDC and “less drastic” cuts at the Centers for Medicare and Medicaid Services.
Former FDA Office of External Affairs Associate Commissioner Erica Jefferson said “the entire FDA media team” has been eliminated, along with “CBER, CDER, CDRH, CVM and Office of Foods communications teams who worked with the Office of the Commissioner communicators to ensure timely and accurate public health information was disseminated to the public” and most of the Center for Tobacco Products communications team.
“Imagine waking up to learn that the FDA as you know it no longer exists,” she said on LinkedIn. “America, buckle up because it’s going to be a very bumpy and likely deadly carnival ride.”
Related: Former CDRH Director Jeff Shuren on what FDA cuts might mean for device developers
Major medical device manufacturers have mostly stayed publicly silent on the layoffs, while industry group AdvaMed last week said that HHS and its subagencies should be “more efficient and accountable” and that “any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech.”
But some medtech leaders are speaking out.
“Reasonable and appropriate regulation of healthcare technology is vital to support not just patient safety but also public trust in innovation,” Adona Medical President and CEO Brian Fahey said on LinkedIn. “The ongoing gutting of the FDA is likely to cause American deaths.”
Medtech manufacturers are also bracing for a new round of import taxes as Trump promises to implement sweeping tariffs this week, which could increase costs for medtech materials, components and finished devices.
The reduction in federal spending combined with new taxes on buyers of goods imported to the U.S. are making a higher inflation and a recession more likely, Goldman Sachs and other analysts are warning.
Manufacturers outside of medtech are also warning of the disruption that Trump’s policies are causing, saying they’re losing business and having a harder time planning for the future.
Former Medtronic CEO Bill George recently weighed in on what he called the Trump Administration’s “game plan,” quoting from a 2021 interview of JD Vance in which he said, “We really need to be really ruthless when it comes to the exercise of power.”
“The challenge confronting American conservatives is that we have lost every major powerful institution in the country except for maybe churches and religious institutions, which of course are weaker now than they’ve ever been,” said Vance, who is now the nation’s vice president. “We’ve lost big business. We’ve lost finance. We’ve lost the culture. We’ve lost the academy. And if we’re going to actually really effect real change in the country, it will require us completely replacing the existing ruling class with another ruling class.”
Remote medtech jobs: These medical device employers have remote job openings
