AdvaMed urges Trump administration to reverse FDA layoffs

The medtech lobby group AdvaMed has asked the Trump Administration to reverse its recent firing of probationary staff at the US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). AdvaMed CEO Scott Whitaker said the administration's broad strokes approach to cutting probationary staff is inconsistent with its stated goals.

On 18 February, Whitaker posted on LinkedIn that he had written to the Department of Health and Human Services urging the Trump Administration to reverse its recent layoffs of probationary workers at CDRH. While staff across FDA have been fired, much of the reporting notes that CDRH has been the hardest hit (RELATED: Firing of FDA probationary staff creates widespread uncertainty, Regulatory Focus, 17 February 2025).

“Working together, we can achieve a more efficient and effective FDA. But, on behalf of our members, I am concerned that the cuts made over the weekend not only will not accomplish that. I am also concerned that it puts at risk our nation’s status as the top medtech market in the world—as the global leader in medtech innovation, manufacturing, and jobs,” said Whitaker. “These cuts were planned before [Health and Human Service Secretary Robert F. Kennedy, Jr.] was even sworn into office. I am sure this latest action would not align with his goal of making America healthy again.”

At a 19 February press conference, Whitaker noted that many of the fired CDRH staff were at least partially funded through the Medical Device User Fee Amendments (MDUFA V) agreement negotiated with the medtech industry and not by taxpayer dollars and that as such, there could be legal implications. The Health and Human Services Department (HHS) has not provided details on the number of people fired from FDA.

Whitaker noted that under MDUFA, FDA was able to hire experts in burgeoning technology areas such as artificial intelligence (AI), cybersecurity, and software as a medical device (SaMD) over the past two years. That could be one reason why this round of layoffs has disproportionately affected CDRH.

"MDUFA, as you all know, has scaled up hiring dramatically in the last two years, and if you're focused on those probation area employees, it's natural that they're going to be the ones that get caught up in it probably at a larger scale than others," said Whitaker.

"If you go back and look at the MDUFA agreement, which was just signed a couple of years ago, they were in the first two years of scaling up,” added Whitaker. “The fact that [CDRH was] scaling up so quickly inadvertently means that they got caught up in that probation category."

Whitaker said that medtech executives have told him they feel uncertain about the impact of the Trump administration’s actions. He said most of them understand what the administration wants but think there are better ways to achieve those goals.

"We've heard from folks who have already gotten notice that current applications may be delayed or suspended, and it's coming in a multitude of areas," said Whitaker.

While Whitaker said that he supports the administration’s efforts to trim the size of the federal government, he said the way they rolled out their plan has had unintended consequences.

"That's what we're trying to help the administration understand,” said Whitaker. “If your intent was to cut some of the fat out of an agency, the result of your action is not that. It's to cut the newest employees with the most specialized skills relative to emerging technologies, particularly in the digital and AI space."

Focus asked Whitaker if the decision to fire FDA staff who were paid under user fees was legal and, if not, whether AdvaMed is considering taking legal action against the government. Whitaker said they don’t want to go down the litigation route, but they are also trying to figure it out.

“We're very squarely focused on the MDUFA side right now to see if we can clean that up a little bit and if that's fixed, then I don't think we have a problem,” said Whitaker. He added, “If the fact is that it isn't fixed and there are a large scale of MDUFA employees that have been impacted by that, then we're going to have to consider what we do about it either through Congress or through other means. We prefer not to go down that path.”

AdvaMed has had a strong relationship with previous administrations and has effectively lobbied for policy and legislation that benefits its members, including rescinding a 2.3% medical device excise tax, which was part of the Affordable Care Act (ACA). Whitaker said that they still have good relationships with people in the administration, but the speed with which the administration is moving makes it challenging for the industry to get its messages heard.

"The secretary just got confirmed, and it's hard to establish relationships with people when they're not in that job,” said Whitaker. “We know a lot of people in and around him, and we've begun those conversations and they're very good conversations, but it's super early to establish relationships that are deep enough to impact policy right now.”

As the next round of MDUFA negotiations begins next year, Whitaker said AdvaMed is paying close attention to how things shake out. He said the administration’s actions will ultimately guide his thinking going into the negotiations.

"I'm hopeful that this just is an opportunity to remind public policymakers of the importance of CDRH in the context of FDA, the importance of a really strong public-private partnership and collaboration in order to help medical technology products get to market," said Whitaker.

Earlier in the week, the Alliance for a Stronger FDA also wrote to lawmakers at key Congressional committees about the mass layoffs. The group said they are concerned that the cuts could make the agency less efficient, harm the US economy, and stifle medical innovation while putting patients and consumers at risk.

“We share in the desire for a more efficient and effective federal government, which could include staffing changes; however, we fear that the current approach could have the opposite impact for FDA-regulated products,” said the Alliance. “We are concerned that the current staffing changes underway may stymie progress and impact emerging areas of need.

“FDA’s historic challenges in recruiting necessary talent, especially while competing with the private market, are well documented,” the group added. “Reducing the FDA's specialized workforce could significantly impair the agency’s essential functions, increasing safety risks to the public, and undermining the trust that consumers place in the safety of their food.”

AdvaMed urges Trump administration to reverse FDA layoffs

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