Editor's Note: Hours after this article was published, the US District Court for the Eastern District of Texas ruled in favor of the Association for Molecular Pathology in a case challenging the US Food and Drug Administration's authority to regulate lab-developed tests. This article has been updated to note this.
NEW YORK – Reviewers at the US Food and Drug Administration working under the uncertainty and pressure of constantly looming layoffs are concerned about the agency's ability to ensure the safety and efficacy of diagnostics.
Since January, President Donald Trump's administration and Elon Musk's Department of Government Efficiency have moved to downsize the federal workforce, including at the FDA. In February, DOGE laid off around 1,000 FDA probationary workers, which hit the agency's Center for Devices and Radiological Health (CDRH) particularly hard, leading to the loss of around 200 staffers by some estimates. The FDA rehired many of those employees after the device industry expressed concern over the status of their products under review at the agency and after a federal judge ordered the FDA to rehire them since the government failed to give sufficient notice before implementing such a large reduction in force (RIF).
The US Department of Health and Human Services gave that notice late last week, announcing an RIF that could impact up to 10,000 federal employees across its agencies. HHS said it will begin informing affected federal workers as early as last Friday. The RIF has a probable effective date of May 27.
In 2024, CDRH had 2,260 employees and received more than 20,000 regulatory submissions, according to one estimate citing an annual report that the agency has since removed from its website. According to multiple reports, around 3,500 FDA employees will be laid off in the RIF, though it is unclear how many CDRH staff will be impacted. In response to a request for comment, the FDA directed GenomeWeb to reach out to HHS, which did not respond ahead of press time.
Reviewers in the FDA's medical device division, whose salaries are funded by industry user fees and who have been caught up in the turmoil at the agency amid the layoffs and rehirings, said there is little job security among staffers from one day to the next and that they are working under immense pressure to meet legally mandated product review deadlines despite reduced staff and diminishing critical expertise. Two reviewers agreed to be quoted by GenomeWeb about their experience on the condition of anonymity out of fear of professional repercussions.
Reviewers under pressure
"Going back to work has been stressful. We're focusing on our work … but when we have review deadlines coming up, having all of these things in your mind makes it very difficult," said one reviewer in the FDA's Office of In Vitro Diagnostics, who was a casualty during what agency workers are calling the "Valentine's Massacre," referring to the layoff notices that DOGE sent to FDA probationary workers on the weekend of Feb. 14.
Medical device reviewers have a data-intensive job of ensuring the accuracy of companies' claims about the safety and efficacy of their tools and tests. "When you are looking at a next-generation sequencing or PCR test, you are looking at Excel files with hundreds or thousands of lines of data. If a sponsor is saying the test [produces a certain] number of false positives, you have to cross-reference that data to make sure that's accurate," the reviewer said. "All medical device reviews are data focused, but IVDs are critical in this aspect. IVDs have very specific types of guidances and processes for review."
"I'm trying my best. I’m trying not to make any mistakes," the reviewer continued. "But I'm working with the sword of Damocles on top of my head. It's definitely not the most optimal mindset to be able to catch issues and mistakes."
In the February round of layoffs, dozens of staffers in the IVD office were impacted, the source estimated. This FDA employee, who was subsequently rehired after the device industry pushed back, has many years of experience working in the federal government and had performed "above expectations" at the FDA, according to manager reviews. In fact, the reviewer had been on a probationary period for a year, per employment rules for federal employees, because of a recent promotion.
However, the termination letter this and other probationary workers received said they were being let go because they didn't perform well, and the agency didn't need them anymore. In shock, the reviewer began madly searching for jobs, and just as they were about to go into a meeting for a possible job opportunity, there was a call from the FDA that the termination had been lifted, and they had only a few days to decide whether they wanted to return.
"I went back purely for financial stability," the reviewer said, noting that because the termination letter said that they didn't perform well, it was uncertain if they'd be eligible for unemployment benefits. However, some FDA employees laid off in February chose to take industry jobs and not return to the agency because they didn't want to work under these conditions, the source said, adding, "that means extra work for everybody, and that's going to be hard to manage."
The job insecurity and stress has continued at the agency as HHS gave notice last week of the RIF and announced it is consolidating 28 divisions into 15 new ones. The changes are expected to save taxpayers $1.8 billion. HHS Secretary Robert F. Kennedy Jr. said in a video posted on the social media site X that "HHS is a sprawling bureaucracy," which despite increases in staffing and budget in prior years, has not improved the health of Americans. "The entire federal workforce is downsizing now, so this will be a painful period for HHS, as we downsize from 82,000 full-time employees to around 62,000," Kennedy acknowledged, adding that the goal is to trim the number of HHS administrators but increase the number of scientists and frontline health providers.
He assured these changes would eliminate waste and inefficiency while improving morale and the quality of service. "We're going to do more with less. No American is going to be left behind."
After hearing the political rhetoric during the presidential campaign, another reviewer in the Office of In Vitro Diagnostics knew that a new administration would make changes at the FDA but didn't expect them to be so sudden and severe. On Feb. 14, a Friday, with some FDA employees having already gotten termination letters, this reviewer compiled all the documents and notes related to ongoing IVD reviews that they were working on and shared it with their boss, so this essential work could continue in case they were let go.
"I agree with government efficiency and making sure that you're doing financially responsible things. That sounds very logical to me, and therefore, [I expected] they would take a very logical approach to learning how the different agencies function, and they would involve key stakeholders and leaders in those decisions," said this reviewer, who was laid off as a probationary employee in February, then rehired, only to be put on administrative leave.
During this process, as this person's employment status changed, there were no processes in place to answer questions from laid-off staff. "It felt incredibly rash … and not very well thought out at all," said the source, who like the first reviewer also received a termination letter stating they weren't performing well despite performance evaluations that said their work was above expectations.
The suggestion in these letters that FDA reviewers aren't doing their jobs is especially "insulting," because they have to meet legally mandated timelines under the Medical Device User Fee Act — 180 days for premarket approval applications and 90 days for a 510(k) filing. "We can't pretend to work," the first reviewer said. "It doesn't work like that."
The second reviewer said they are now hearing from colleagues inside the agency that with reduced staff, reviewers' workloads have gotten heavier, making it harder for them to take a deeper dive into the data in these massive application files. The source has also heard from colleagues on the inside that unless there's something "horribly egregious" in these applications, reviewers are "being told to just get them through," which is making some reviewers reluctant to cite smaller deficiencies that they otherwise would. If what this reviewer is hearing from FDA colleagues is true, then that indicates "there's a lowering of the standards compared to what we're usually doing," the source said. "[And] they're trying to balance not upsetting the industry that is applying to the FDA while also trying to ensure [product] safety and efficacy."
Sheila Walcoff, CEO and founding principal of regulatory consulting firm Goldbug Strategies and former FDA associate commissioner, said she has interacted with FDA review staff alongside clients seeking feedback on multiple submission types for molecular tests in late October before the presidential election, in January, before Trump's inauguration, and again at the end of February, after the layoffs and in-person work requirements for staff had begun. The biggest difference that Walcoff noticed over these three periods is in the level of activity at the agency's White Oak campus in Maryland. In October, there were so few people at the FDA's campus that most of the main atrium and hall lights weren't on, she recalled, but by the end of February, many of the managers were there in person.
All three meetings between sponsors and the FDA that Walcoff attended were hybrid, involving a mix of in-person and online attendance, and she said she “didn't notice a difference in the FDA's willingness and ability to engage in conversations with us." When she learned how hard-hit the FDA's Division of Molecular Genetics and Pathology was by the firings last month, Walcoff said she was initially concerned about the status of her clients' applications, but she has been reassured to learn that the agency has rehired most of the staff in that group.
However, at the last FDA meeting in late February, Walcoff could sense that FDA staffers were more stressed. FDA review teams are very dedicated, she said, and "they are definitely doing their best to manage."
Concerns as LDT oversight comes into focus
The workforce reductions come as the FDA, controversially, is moving to bring laboratory-developed tests under its oversight. "How are we going to do all that work if we're going to have to review LDTs potentially, and they're reducing the workforce?" the first reviewer said. "It's going to be chaos."
After many decades of trying to bring LDTs under its oversight and being thwarted by lab industry pushback, the FDA last May published a final rule on its plan to phase in premarket review of LDTs over four years. Although LDTs are currently regulated under the Clinical Laboratory Improvement Amendments administered by the US Centers for Medicare & Medicaid Services, the FDA has argued that the growing complexity and widespread use of LDTs necessitate greater assurance of their safety and efficacy to protect public health.
The agency plans to roll out requirements in five stages, the first of which is approaching quickly on May 6, when it will expect labs to comply with medical device reporting, correction and removal reporting, and quality system (QS) requirements regarding complaint files. Next year, labs will have to comply with registration and listing, product labeling, and investigational use requirements; in 2027, they'll have to meet other QS requirements. Premarket review requirements will start in the fall of 2027 for high-risk LDTs and for moderate- and low-risk devices in 2028.
The agency has said it will exercise enforcement discretion over several types of LDTs, such as tests marketed before publication of the final rule and not altered and tests for unmet needs made and performed at labs integrated within health systems. While these carve-outs are expected to reduce the number of LDTs that the FDA must oversee, the implementation of the final rule is still expected to significantly increase reviewers' workload.
To Bruce Quinn, a regulatory and reimbursement consultant to diagnostics companies, the LDT final rule, which could cost the FDA and industry multiple billions of dollars annually to implement, seems completely anomalous to the Trump administration's small-government objectives. "It seems very hard to imagine how reviewers could do 10 to 20 times more work while they have shrinking staff," Quinn said. "That's kind of mind-boggling."
Whether the FDA will ultimately implement the LDT rule depends on the outcome of a lawsuit challenging the agency's authority to regulate the space. The American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) have both sued the agency arguing that it lacks the authority to regulate LDTs and that the final rule violates the Administrative Procedure Act. The lawsuits have been consolidated and the case was pending in the US District Court for the Eastern District of Texas until today, when the court granted AMP’s motion for summary judgment and vacated the rule through which the FDA sought to regulate LDTs as medical devices under the Federal Food, Drug and Cosmetic Act. It remains to be seen how the agency will respond.
In oral arguments in February in that case, a lawyer for the US Department of Justice defended the FDA's legal authority to issue the final rule, a surprise to many who expected the Trump administration to take the opposite stance. Quinn predicted that if the FDA wins in court, then the government will be constrained to defend the rule, especially if ACLA and AMP appeal the decision. If the FDA loses, on the other hand, Quinn expects the government will reassess its stance on LDT regulation, especially if more conservative-minded employees that served during the first Trump administration are brought in. For example, Brett Giroir, who was HHS assistant secretary for health during Trump's first term and then served as acting FDA commissioner for a few months in 2019, has reportedly been tapped as an adviser to Kennedy at HHS.
The timing of workforce reductions is less than ideal if FDA maintains its regulatory timelines for LDT oversight, agreed Julie Eggington, cofounder and CEO of the Center for Genomic Interpretation, a nonprofit that helps labs, regulators, and payors ensure the clinical and analytical validity of genomic tests.
"People at the FDA working in the diagnostics space do excellent and important work safeguarding the public. I don’t see the value to the public in disrupting the operations of the FDA when the FDA needs to prepare for regulating LDTs," said Eggington, who is an outspoken proponent of FDA regulation of LDTs. "This disruption of FDA employees seems to me to be collateral damage that is most likely to do more harm than good to the general public in the long run. I hope things settle down quickly."
Walcoff believes things will settle down at the FDA as more leadership positions are filled. She noted, for example, that biotech investor Jim O'Neill, who served in HHS under President George W. Bush and understands IVDs, has been nominated by Trump to serve as deputy HHS secretary. While the new administration has lots of big priorities and the LDT final rule may not be at the top of the list, Walcoff believes O'Neill will be someone who can provide more stability to the sector on this front.
While Walcoff wasn't willing to speculate on where the already-in-effect LDT regulation will fall if it is reassessed, she said she'll be seeking more clarity from the FDA on deregulatory mechanisms like the pending down-classification of companion tests, announced by the FDA over a year ago, and fully implementing the FDA’s new authority for using predetermined change control plans to reduce burden on labs and the agency.
Ultimately, it remains to be seen if the federal downsizing will jeopardize the FDA's ability to ensure the safety and efficacy of IVDs, a category the agency says LDTs fall under. While the May 6 deadline for implementing the first stage of the rule may not represent that much added work, labs readying premarket submissions in a few years will increasingly want to meet with the FDA through the pre-submission program to garner feedback, which could put review staff under significant strain. As Hyman, Phelps & McNamara lawyers Jeff Gibbs and Allyson Mullen recently wrote in the FDA Law Blog, a surge in pre-submission applications while the agency is short-staffed may cause delays in feedback or result in no feedback at all. "Only time will tell if the current FDA disruptions will matter over the next few years," Eggington said.
Meanwhile, both FDA reviewers, despite the pressure they're under, said they joined the agency because they deeply believe in public service and its commitment to unbiased science and protecting the public health. "I love the FDA," said the second reviewer. "Everybody I ever worked with there was fantastic. I have nothing negative against the agency, but it has essentially, in my opinion, been taken over from the outside."
If you're working on genomics research, in vitro diagnostics, or precision medicine and have been impacted by government workforce reductions, please email [email protected] to share your experience.