Experts: Trump’s FDA moves create uncertainty, opportunities for other regulators

Editor’s Note: This article has been updated to clarify a statement by one of the panelists regarding IMDRF participation.

LINTHICUM HEIGHTS, MD – The upheaval at the US Food and Drug Administration (FDA) under the Trump Administration has created significant uncertainty for healthcare product stakeholders, according to experts who spoke at RAPS Regulatory Intelligence Conference. Those moves may create a leadership void on the global stage that other regulators could fill in the coming years.

Josh Silverstein, director for regulatory science and policy at Philips, and Amra Racic, vice president for global government affairs at Veeva Systems, presented on these and other regulatory trends during a session on Friday. One of the key updates they discussed was the Trump administration’s actions to downsize FDA and limit certain activities, such as staff travel, communication, and the issuance of new regulations.

"The situation in the US, or the current climate, is impacting Europe,” said Racic. “It's impacting the rest of the world. There's definitely a domino effect."

She said that one area that is seeing an effect is global regulatory harmonization.

President Donald Trump issued a slew of executive orders that have affected FDA, including restricting the ability of agency staff to communicate with external stakeholders. Notably, FDA staff, who typically play a significant leadership role in the International Medical Device Regulators Forum (IMDRF), were not present in person at the group’s spring meeting in Tokyo earlier this year.

Racic said that experts have told her that European Commission officials are readying for the prospect of taking “the driver’s seat” at IMDRF's working groups due to FDA’s apparent staff limitations. She noted that communication limitations will probably ease up after the agency gets a permanent commissioner – expected to be Johns Hopkins surgeon Martin Makary after his nomination was sent to the full Senate for consideration last week – but budget limitations and other factors will likely limit how the agency engages with external stakeholders.

“Different organizations that I interact with and work with have already started to make changes to bring their conferences closer to where the FDA is,” she said. “This is going to be more of a busy place to come because everybody is going to try and roundup around the Washington area to make it easy for them to come in in-person.”

Racic told attendees that while the executive order prevents FDA staff from participating in conferences and other events, the agency is still able to communicate on issues that relate to device reviews and other urgent matters.

Silverstein noted that there has been a loosening of communications beyond direct talks between FDA and manufacturers, that included discussions related to premarket submissions, postmarket surveillance, and inspections.

“Where we’ve started to see a little bit of loosening up so far is in standardization,” he said. “Initially, FDA walked away from standards entirely.”

Silverstein noted that while FDA didn’t attend a recent meeting on the ISO/TC 210 standard on quality management and isn’t voting on the standard, it is back at the table and is listening to the discussions around the standard. He said it is an important development not only for the future of medical technology but for global harmonization and patient safety.

As a regulatory intelligence professional, Silverstein also voiced frustration that FDA hasn’t been able to send out regular email updates with information, such as updates to its website and developments regarding premarket submissions, which are necessary for medical manufacturers and other stakeholders. The lack of communication has meant that regulatory professionals like himself have missed the information they need to inform their clients.

Racic also noted that FDA has been trying to comply with President Trump’s directive to rescind any language in its documents that the administration deems to be related to diversity, equity and inclusion (DEI). As a result, she noted that the agency has been updating documents and regulations, often in the evenings and weekends, leaving stakeholders unaware of the changes.

“Unless you are going in and double checking and triple checking, it is really difficult to know what has changed and what has not changed,” said Racic.

Silverstein added that in some of those cases FDA was compelled to change those documents back due to a court order. He added that the administration’s actions and court orders have created an atmosphere where regulatory intelligence professionals feel like they are on a pendulum trying to figure out where regulations land, which makes it hard for them to advise their clients.

Racic highlighted the impact of Trump’s executive order to rescind 10 regulations, rules, or guidances for every new one that is issued.

“I don’t think, at least in the short term, that we’ll be seeing very many regulations come out from the FDA unless they figure out innovative ways to find a way around the 10-for-one [order],” she said.

Racic noted that FDA will likely prioritize fulfilling statutory requirements such as reviewing premarket submissions, but other programs, such as the Voluntary Improvement Program (VIP), are more likely to languish.

Silverstein agreed and noted that he has heard that when FDA staff send their weekly emails listing five things they achieved that week, they prioritize work that is congressionally mandated. He added that this raises questions about how FDA is getting other work done, such as holding pre-submission meetings, which are not in statute.

More broadly, Silverstein said the personnel cuts and other actions taken by the Trump administration have created more uncertainty and risk for the sector.

“A lot of the muscle that [the Center for Devices and Radiological Health (CDRH)] has built up over the last few years was in [artificial intelligence (AI)] and other digital health matters,” Silverstein added. “Some of those people are gone, maybe they’re on their way out.”

“It does present uncertainty for the future,” he added.

Experts: Trump’s FDA moves create uncertainty, opportunities for other regulators

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