Massive FDA Layoffs Spark Outrage and Uncertainty

In a sweeping move tied to President Donald Trump’s push to shrink the federal government, thousands of employees at the U.S. Food and Drug Administration (FDA) were abruptly laid off in the morning of April 1, 2025. Many only learned of their termination after arriving at work, where they were instructed to collect their belongings and leave.  Layoff notices began arriving at 5 a.m., workers said, affecting offices responsible for everything from global health to food safety. And it wasn’t an April Fool’s joke!

The layoffs followed last week’s announcement by Health and Human Services (HHS) Secretary Robert Kennedy Jr. of a planned reduction in force (RIF) to shrink his department from 82,000 to 62,000 employees.  In addition to the 10,000 who had already been fired or left voluntarily, this Tuesday’s layoff affected 10,000 additional employees.  Peter Marks, the Director of FDA’s Center for Biologics Evaluation and Research (CBER) was given the choice of resigning or being fired.  His last day will be April 5.  Reactions on social media said that he was forced out of CBER for speaking out his concerns of the impact of pseudoscience in regulation of lifesaving medicine in his efforts to uphold scientific rigor and refusing to kowtow to lies.

Several high-ranking officials were also terminated, including Peter Stein (Office of New Drugs), Brian King (Center for Tobacco Products), and Julie Tierney, who was slated to lead the Center for Biologics Evaluation and Research (CBER). The FDA’s leadership page now shows vacancies for CBER director and chief counsel.

Despite weeks of speculation and internal anxiety, many employees had hoped they would be spared. One anonymous worker based in Denver said they checked their email late into Monday night, saw nothing, and commuted to work—only to find the termination message waiting in their inbox when they arrived.

Backlash and Political Response

Former FDA Commissioner Robert Califf expressed dismay on LinkedIn: "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,"…. "I believe that history will see this a huge mistake.”

Rep. Rosa DeLauro (D-CT), ranking member of the House Appropriations Committee, said the cuts jeopardize public health. “They fired scientists tracking infectious diseases like HIV and measles…..” “They fired experts working on treatments for cancer, Alzheimer’s disease, and other debilitating diseases…..” “They fired people tasked with making sure our food and drugs are inspected and safe.”

Mixed Political Reactions

While many decried the mass firings, others applauded them. Sen. Jim Banks (R-IN), a member of the Senate HELP Committee, shared a video on social media mocking a fired HHS employee as a “clown” and defending the cuts.

Industry Reacts with Cautious Optimism and Concern

AdvaMed, the influential trade group representing medical device manufacturers, struck a more measured tone than in its February criticism of earlier FDA cuts. In a statement, CEO Scott Whitaker expressed alignment with HHS Secretary Robert Kennedy Jr.'s goals of greater efficiency and accountability.

“If it’s true that medical device reviewers and inspectors haven’t been affected, then that’s good news,” Whitaker stated. “Looking forward, our view is that any reduction in force should be accompanied by policy and regulatory improvements that encourage innovation in medtech.”

However, others expressed deeper concerns about the impact of the layoffs on key FDA functions. Madris Kinard, a former FDA analyst and now CEO of Device Events, highlighted the loss of staff responsible for processing Freedom of Information Act (FOIA) requests—a role confirmed to be impacted by a current employee at the Center for Devices and Radiological Health (CDRH).

“The FDA receives sensitive patient data in adverse event reports, which must be carefully redacted to protect identities,” Kinard explained. “Without FOIA personnel, this safety data can’t be released monthly as required.”

Final Thoughts

There is no scenario in which eliminating nearly a third of the Department of Health and Human Services’ workforce is a good idea—especially when these individuals are responsible for safeguarding the food, drugs, and medical devices relied upon by the American public. As recently as a few weeks ago, FDA scientists reported being reassigned nearly double the number of new applications due to February’s wave of layoffs. Many of them now fear they will be unable to meet their deadlines. For some applications, FDA reviewers are expected to complete their reviews within 180 days, but with this increased workload, that target seems completely out of reach. And now, an additional 10,000 employees have been let go?

One crucial program offered by the FDA to medical device and diagnostics manufacturers is the Pre-Submission meeting. These meetings—free of charge—allow companies to align with the FDA on analytical and clinical study designs before full submissions. They are incredibly valuable for securing early regulatory buy-in. During the pandemic, these meetings were suspended so FDA could focus on COVID-19-related products, which was understandable at the time. Their return was a welcome relief for the industry. However, with such a significant workforce reduction, it’s very likely these meetings will once again be deprioritized or eliminated.

Losing this opportunity for early feedback could mean companies are forced to repeat clinical trials, delaying product development and driving up R&D costs. Fewer reviewers will naturally lead to longer review times, slowing down patient access to life-saving treatments and diagnostics. Ultimately, this will likely result in increased prices for medicines and medical devices.

While I support the elimination of redundant or unnecessary roles, these widespread firings seem far more harmful than helpful.