Firing of FDA probationary staff creates widespread uncertainty

Correction: This article has been updated to clarify Jay Vaishnav’s former title at FDA.

An unknown number of probationary staff at the US Food and Drug Administration (FDA) were fired this weekend as part of the Trump Administration’s effort to shrink the size of the federal government. While the administration has not provided any specifics on the scope of the reductions, the round of firings, which affected staff across several federal health agencies, targeted workers with fewer employment protections.

Focus contacted the Department of Health and Human Services (HHS) and FDA for more details about the layoffs; however, officials have declined to comment as of publishing.

On 15 February, numerous probationary staff at FDA began receiving emails notifying them they had been fired. CBS News obtained a letter that outlined the reasons that staff at the Department of Health and Human Services (HHS) were given for their firing.

"Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency's current needs, and your performance has not been adequate to justify further employment at the Agency," said the letters.

Former FDA Commissioner Robert Califf told Focus he's waiting to learn the "full extent of the purge" before making a complete assessment, though he shared his preliminary thoughts on LinkedIn and BlueSky.

“I am grieving for the many talented and dedicated FDA employees who have been mistreated and those left to do the work of protecting public health,” Califf wrote. “Also, for those who will be harmed by this among patients and the public.”

“Those who are complicit in their silence will be judged harshly by history,” he added.

During his tenure, Califf prioritized increasing pay and incentives for FDA staff to ensure the agency's competitiveness with the private sector. However, the Trump administration has actively encouraged federal workers to leave their jobs for the private sector. (RELATED: FDA officials say FY 2025 budget increase needed to offset inflationary pay increases, Regulatory Focus 16 April 2024)

In a recent letter to federal workers, the administration urged employees to take a deferred resignation and leave their jobs by 30 September. "We encourage you to find a job in the private sector as soon as you would like to do so," the letter stated. "The way to greater American prosperity is encouraging people to move from lower productivity jobs in the public sector to higher productivity jobs in the private sector."

Jay Vaishnav, director of regulatory affairs at Canon Medical Informatics* and a former acting associate director of the Office of Science and Engineering Laboratories (OSEL) at the Center for Devices and Radiological Health (CDRH), told Focus that during her tenure at the agency, the review divisions were generally understaffed, and it was particularly difficult to recruit and retain staff with specific clinical expertise and expressed concern about the impact of the recent cuts.

"Since those days, the Agency has made a lot of progress, with the increased ability to recruit people outside the DC area helping them fill a lot of gaps in knowledge," said Vaishnav. "I am concerned about the loss of talented people with specialized training.”

“Review work is complex and highly technical, and training a good reviewer takes a long time--about two years,” she added. “I am also concerned about the loss of research scientists, whose work informed complex reviews."

While the Trump Administration may be pushing FDA staff to join the private sector, Vaishnav said that may not be viable for many who have been laid off.

"Many medtech companies, especially startups, had a difficult 2024 and had rounds of layoffs,” she said. “I am uncertain about the ability of the regulatory space in the private sector to absorb a large number of displaced FDA staff at once."

Since the layoffs targeted probationary workers, Vaishnav said they hit staff recently hired to work on burgeoning fields such as artificial intelligence and machine learning (AI/ML) in medical imaging devices the hardest. AI/ML is still a very new area for the agency, and medtech manufacturers rely on FDA's Q submission process for input on their products. Vaishnav said she is concerned that the firings will demoralize remaining staff and could slow down regulatory decisions.

"In industry, time is money, and predictability of timelines is as important as the timelines themselves," said Vaishnav. "Small companies can fold entirely if a marketing authorization takes too long. Delays in products reaching market do not benefit the public."

"Industry needs good people at the FDA," she added. "FDA review staff have knowledge and skills that transfer particularly well to the private sector, and have a number of career options. Instability and large-scale turnover make the FDA a less attractive place to work, which I do not see as being in anyone's interest."

Quentin Moore, who served as an FDA reviewer specializing in artificial intelligence and software as a medical device (SaMD), posted on LinkedIn about his firing. He said he began working as a senior staff fellow on the imaging software team almost three years ago and earned a competitive promotion about a year ago with a probationary period that was to end this week, which would have made him a career civil servant. However, like other FDA staff he received an email this weekend telling him that his employment was terminated.

"I have been holding my breath for a few weeks but with only one week to go in my probation period, I was let go for reasons fully outside of my control," said Moore. "In life we can look at significant events like these as unfortunate ends, or exciting new beginnings. It is time for me to explore new opportunities with an open mind, and optimistic attitude."

Jason Brooke, a medical device attorney, also took to LinkedIn to express his concern that firing FDA staff will negatively impact the industry.

"I am disheartened to hear that, on this President's Day weekend, the FDA has been forced to fire many qualified professionals," he said. "From what I'm hearing, CDRH employees appear to have taken the brunt of the impact (as compared to the other centers)."

"Even before the current administration, efforts to staff the FDA was difficult," he added. "The loss of these talented professionals will have significant, deleterious effects on the Medical Device industry and the patients who rely on life-saving innovative technologies. The impact will be felt for many years to come."

According to sources with knowledge of the details, other high-level FDA probationary staff have also been affected by the recent purge. They noted that Ross “Rusty” Segan, director of the Office of Product Evaluation and Quality (OPEQ) at CDRH, who joined the agency last September, was allegedly among those let go.

Focus has reached out Segan and CDRH for confirmation but has not heard back as of publishing.

Sources, however, have confirmed to Focus that so far, seven employees were fired from the Office of Center Director (OCD) at CDRH, as well as 17 staffers from the Office of Strategic Partnerships and Technology Innovation (OST). So far, at least 20 staffers at the Office of Neurological and Physical Medicine Devices (OHT5), 17 at the Office of Radiological Health (OHT8) and 18 at the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) have also reportedly been fired. The sources note that the situation is rapidly evolving, and additional layoffs may happen in the coming days and weeks.

“A lot of us feel like that we don’t have a voice and industry does,” an FDA staff member who has been granted anonymity due to fear of reprisal told Focus. “I'm seeing them starting to step up and I'm hoping it is sustained.”

“We're all in this together, we're all trying to get to the end goal, which is to get good products to the market,” the source added.

Medtech lobby group Advamed told Focus they are looking closely at the administration's actions and will comment further when they have a better sense of their potential impact. In particular, the group is evaluating whether the layoffs will conflict with the new full-time equivalent (FTE) requirements agreed upon with FDA under the Medical Device User Fee Amendments (MDUFA V) deal.

“We understand the ultimate goal of ensuring a more efficient and accountable federal government across the board," said AdvaMed CEO Scott Whitaker. "It is critically important, however, that the process of getting the latest and most promising US medical technologies into the hands of our doctors and patients isn’t put at risk."

"A strong and effective FDA is an essential element of that process," he added. "Patients’ lives, as well as our nation’s global leadership in medtech innovation, manufacturing, and jobs are potentially at stake."

FDA wasn’t the only health agency that was affected by this weekend’s purge. More than a thousand employees at the National Institutes of Health (NIH) were also fired this weekend, according to Reuters.

Advocacy groups, including Friends of Cancer Research, the American Diabetes Association, and UsAgainstAlzheimer's, wrote to the administration on 14 February, raising concerns that firing staff at health agencies would hamper medical research in the US and prevent new treatments from coming to market.

“The cumulative effects of threatened cuts to federal health research funding and forced departures at our nation’s premier health agencies will put our global leadership and our nation’s health at risk," said the group.

“The February 11 executive order to cut the federal government wisely exempts our military and public safety infrastructure," the letter added. "Health is an essential component of public safety and national security, and therefore, we respectfully urge the President to include our health agencies as a part of the executive order’s exemptions."

*Jay Vaishnav’s statements reflect her opinions and not those of her company.

Firing of FDA probationary staff creates widespread uncertainty

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