Regulatory

AdvaMed Warns of ‘Negative Impact’ From FDA Job Cuts

Organization's CEO claims the government's attempt to reduce the federal workforce will lead to slower product review times and jeopardize U.S. medtech leadership.

By: Michael Barbella

Managing Editor

Photo: Andrey_Popov/Shutterstock.

The medical device industry’s largest trade group is pushing back at the Trump Administration’s efforts to reduce the federal workforce.

Within days of mass terminations at the U.S. Food and Drug Administration (FDA), AdvaMed issued a stark warning about the potential impacts of job cuts on the medical device industry. President/CEO Scott Whitaker expressed his concerns in a Feb. 18 letter, claiming the dismissals are counterproductive to politicians’ mission to streamline U.S. government. Whitaker compiled the letter roughly two weeks after penning a missive to the Trump Administration requesting the industry be exempted from tariffs.

“Over the weekend, significant job cuts were made to the FDA that could have a very negative impact on patient care in this country,” Whitaker wrote in his letter to the U.S. Department of Health and Human Services. “We understand and support the administration’s overall goal to be more efficient with the taxpayer dollar. Our concern is that this round of cuts to FDA staff runs counter to that shared goal.”

First announced in mid-February, the terminations mostly affected FDA employees working in the agency’s centers for food, medical devices, and tobacco products. No precise totals were provided for the number of employees who lost their jobs, but the Associated Press reported that probationary workers were notified on Feb. 15 about the cuts. It was not clear whether workers who review drugs were among those being fired.

However, barely a week after receiving termination notices, some probationary staffers learned the government wanted them back on the job. FDA employees overseeing medical devices and other key areas received calls and emails on Feb. 21 (in the evening) notifying them that their recent terminations had been “rescinded effective immediately,” according to messages viewed by The Associated Press.

Still ‘Time to Change Course’

In his letter, Whitaker claims the FDA workforce reduction will slow product review times and jeopardize U.S. medtech innovation.

“Device review times were already too long, though they were improving as the result of our latest user-fee agreement. FDA was already struggling to keep pace with our industry’s tens of thousands of new medical technology applications every year, all of which are intended to improve the lives of patients in this country,” Whitaker’s letter reads. “And in this regard FDA was improving as well (and also due to our latest user-fee agreement). That agreement, for the first time ever, created private sector-like incentives for FDA to be more efficient, transparent, and predictable in its review process. And this was of tremendous benefit to the patients whose lives and health depend on access to America’s leading-edge medical technologies and treatments.”

“Unfortunately, as a result of these reductions, FDA will lose hundreds of new employees, the best and most innovative hires under our most recent agreement,” the letter states.

Whitaker urged the Trump Administration to work with the industry to achieve dual missions of a streamlined government and more effective FDA.

“…there remains time to change course. Working together, we can achieve a more efficient and effective FDA,” he said. “But, on behalf of our members, I am concerned 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.”

“AI in healthcare is a clear, illustrative example. hashtag#AI is driving earlier and more accurate diagnoses, which means earlier treatments and better outcomes for patients—which, in turn, translates into lower costs to patients and to our health care system overall. 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.”

“These cuts were planned before Secretary Kennedy was even sworn into office. I am sure this latest action would not align with his goal of making America healthy again,” Whitaker noted. “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.”

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