According to the report, the administration fired recently hired FDA employees reviewing, among other things, medical devices. Probationary employees (those hired within 1-2 years) in the FDA received notice of job elimination on Saturday evening, AP says. The news outlet cited three FDA staffers speaking on the condition of anonymity.
Multiple posts on LinkedIn suggest that employees received template letters outlining their termination. One employee said the letter they received stated that they were terminated due to “inadequate performance,” despite a high score on their most recent performance review.
A terminated NIH employee said all probationary employees received the same letter claiming “performance has not been adequate to justify further employment at the Agency.”
AP said the total number of positions eliminated remain unclear. AdvaMed President and CEO Scott Whitaker told MedTech Dive that he heard between 230 and 240 people were cut at the FDA’s Center for Devices and Radiological Health (CDRH).
Cuts appeared to center around employees in the agency’s centers for food, medical devices and tobacco products. This follows reports that officials expected the U.S. Dept. of Health and Human Services (HHS) to fire 5,200 probationary employees after the confirmation of Robert F. Kennedy Jr. as HHS secretary last week.
According to the report, anonymous AP sources said they expected nearly 1,300 CDC employees to get laid off. As of early Sunday afternoon, the AP said about 700 people had received notices.
(Read about on the Trump administration’s actions and their potential impact on medtech HERE.)
AdvaMed statement on latest cuts
An AdvaMed spokesperson shared the following statement by Whitaker with MassDevice via email:
“We understand the ultimate goal of ensuring a more efficient and accountable federal government across the board. It is critically important, however, that the process of getting the latest and most promising U.S. 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. Patients’ lives, as well as our nation’s global leadership in medtech innovation, manufacturing, and jobs are potentially at stake. We are looking closely at this latest action, and will have further comment when we have a better sense of its potential impact.”
Whitaker later took to LinkedIn to announce that he sent a letter to HHS outlining concerns about the job cuts.
“We understand and support the administration’s overall goal to be more efficient with the taxpayer dollar,” Whitaker wrote. “Our concern is that this round of cuts to FDA staff runs counter to that shared goal.”
He added that there “remains time to change course,” but, on behalf of AdvaMed’s members, is concerned that the cuts put the industry in a place in which it can’t accomplish that. Whitaker also expressed concern that it puts at risk the U.S.’s status as the top medtech market in the world. That particularly rings true with AI and the cutting of jobs in the AI space at the agency.
“Eliminating FDA’s recent critical new hires in the AI space will dramatically slow review times and require reassigning non-experts already at FDA to review these technologies who will inevitably make slower and potentially inappropriately conservative decisions,” Whitaker said.
He concluded by saying the cuts were planned before Kennedy was sworn in. Whitaker said he feels the cuts “would not align” with Kennedy’s “goal of making America healthy again.”
“I hope we are able to work with Secretary Kennedy, his leadership team, and that of FDA to reverse these cuts, and then put our heads together on policies that will achieve the aims of President Trump and DOGE but without putting patients and America’s leadership role in medtech at risk,” Whitaker said.
FDA firings have an interesting relation to Musk’s Neuralink
Reuters reports that the FDA cuts extended to some agency employees reviewing Elon Musk’s Neuralink brain-computer interface (BCI) company.
The report said the firings included around 20 people in the FDA’s office of Neurological and Physical Medicine Devices. Several of those employees worked on Neuralink and other BCI devices, the report said, citing two sources with knowledge of the matter.
Reuters said both sources did not believe the Trump administration — and Musk as head of the Dept. of Government Efficiency (DOGE) — specifically targeted them due to their work on Neuralink’s regulatory submissions. The report, however, quoted former FDA official, Victor Krauthamer, expressing concern over the impact the cuts could have. Krauthamer spent more than three decades at the FDA and spent time as acting director of the office that reviews human trial requests for BCIs.
“It’s intimidating to the FDA professionals who are overseeing Neuralink’s trial,” said Krauthamer. “We should be worried about the whole trial, and the protection of the people in the trial.”
Commentary from former HHS heads
A group of leaders former HHS leaders, including Carole Johnson (HRSA); Dawn O’Connell (ASPR); Miriam Delphin-Rittmon (SAMHSA); Mandy Cohen (CDC); Chiquita Brooks-LaSure (CMS); Robert Califf (FDA); Monica Bertagnolli (NIH); and January Contreras (ACF) released a joint statement:
“We are honored to have worked with dedicated and skilled public servants who have been leading the fight for a healthier America at the U.S. Department of Health and Human Services (HHS).
“The Trump Administration now has begun arbitrarily removing HHS staff from their positions, leaving no doubt that the health and well-being of families and communities across the country will suffer as a result.
“The work of the members of the HHS team is not just important to the health of this country, it is also vital to the economic security of our nation. … These individuals are not numbers on a spreadsheet. They are dedicated and passionate public servants who have committed their careers to working on behalf of the American people.
“We owe them a debt of gratitude, not a pink slip.”
More from former FDA head Robert Califf
Kelly Gordon, CEO and founder of Boudicca Dx, took to LinkedIn to share her thoughts on the FDA cuts. Her post also elicited a response from Califf, the former head of the FDA.
Gordon said she worked with CDRH for more than 13 years as an IVD and medical device developer and is “so devastated” to hear about the cuts.
“The majority of CDRH reviewers are scientists who have dedicated their entire careers to bring medicines and clinical tests to Americans,” she wrote. “America leads the world in drug and device approvals-this is not an area of our government that needs an efficiency improvement! With the surge in emerging precision medicine technologies, this is the absolute wrong time to let CDRH reviewers go! They should be retained!”
In response to Gordon’s post, Califf shared his disappointment in the developments at the FDA.
“I am grieving for the many talented & dedicated FDA employees who have been mistreated & those left to do the work of protecting public health,” he said. “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.”
Affected FDA employees take to social media
Here are some LinkedIn posts from current and former FDA employees detailing the impact of the latest cuts:
Nathan Weidenhamer (biomedical engineer at FDA):
“Unfortunately, I was impacted by HHS’s recent decision to terminate probationary employees at the FDA. I am proud of the important work I accomplished with my colleagues in support of the FDA’s public health mission. I fear that these cuts will further exacerbate the challenges faced by the Agency to complete thorough regulatory review in a timely fashion. My colleagues in industry should be alarmed by these recent events and the potential impact to their development timelines.”
Ramin Bighamian (biomedical engineer at FDA):
“I usually don’t talk about myself or my professional life on social media, but I feel it’s important to share the real impact of the recent federal layoffs on young professionals. Yesterday, I was terminated via a template letter—despite consistently receiving outstanding performance evaluations throughout my federal service. … After completing a full year of leadership training to prepare for a leadership role last year, I am now being terminated with just three months left in my probation—despite nearly six years of service.”
Julie Sullivan (FDA/CDRH division director — Radiological Imaging and Radiation Therapy Devices):
“My office in CDRH was not spared from the purge that happened this weekend. We lost some really excellent people in the radiological health space who are now looking for work. Members of our teams have expertise in AI/ML, x-ray imaging (e.g., CT, mammography), radiation therapy- including carbon ion therapy, and software. They’re adaptable, innovative, and hardworking.”
Ghada Zhamzmi (staff scientist at FDA CDRH):
“I never thought I would say this, but unfortunately, I have been terminated from my position as a Senior Staff Scientist for reasons beyond my control. The termination was sudden, without notice, and without valid justification. It’s hard to comprehend why a group of AI researchers working on regulatory science was abruptly terminated. … To my colleagues still at the FDA—I’ve been privileged to work alongside you. I know you’re under pressure, facing uncertainty, and mourning the loss of your peers. But please, keep pushing forward. Your work is more important now than ever.”
Ryan Pewowaruk (biomedical engineer & regulatory affairs):
“Unfortunately, I was affected by HHS’s decision to terminate probationary employees at the FDA over the weekend along with countless colleagues. I am incredibly proud of the important work my colleagues and I have performed in support of the FDA’s mission to protect and promote public health, and I fear that these cuts will directly limit the U.S. public’s access to safe and effective medical technologies.”
Brendan Weintraub (National Institute of Mental Health):
“On Friday, my fiancé and I were unfortunately a part of the thousands of Americans across U.S. Department of Health and Human Services (HHS) to be terminated, without proper cause, due to our status as probationary employees (i.e., having been hired within 1-2 years). According to the letter I received on Friday, I was terminated due to ‘inadequate performance,’ after just receiving the highest score possible on my most recent performance review.”
Taili Thula (biomedical engineer):
“My position as a biomedical engineer/lead reviewer was abruptly ended by HHS’s recent decision to terminate probationary employees at the FDA. Although my job was suddenly taken away without real justification, my gratitude to my colleagues and stakeholders as well as the satisfaction and pride for a work well done can never be taken away. … Unfortunately, these massive cuts are dramatically increasing the challenges already faced by the Agency due to understaffing, which will sadly hamper the safety of the public and the evolution pace of medical devices in the U.S. market.
Ashley Hackett (communications manager, NIH):
“Along with around 1,500 NIH workers, my employment was terminated on Saturday night with the explanation that our ‘performance has not been adequate to justify further employment at the Agency.’ This same language was sent to all NIH probationary employees, or people who had been federally employed at the agency for less than two years.”
