An inside look at the changing culture of the FDA
The U.S. Food and Drug Administration (FDA) remains committed to advancing public health, but changes under the Trump administration have made communication with industry less predictable, raising concerns about transparency and the development of new medical technologies.
Health Exec spoke with Aubrey Shick, a digital health policy expert on regulatory and product strategy with Launch and Logic LLC, and a former senior digital health advisor at the FDA, in the above video interview. She said agency reviewers remain committed to their public health mission. However, she said the agency has become less visible in industry discussions as leadership navigates policy changes, staffing challenges and uncertainty over the administration’s regulatory approach.
“At the heart of it, the reviewers’ hearts are still in the same place,” Shick said. “The teams that are still at FDA, they’re very committed to moving things forward in public health.”
The challenge, she said, is that agency staff appear to have fewer opportunities to communicate publicly about regulatory developments, engage with innovators and explain how the FDA is approaching emerging technologies, including artificial intelligence (AI) in healthcare.
Less FDA communication with industry
Shick pointed to resources developed by the FDA’s Digital Health Center of Excellence, including a regulatory accelerator intended to help innovators navigate the regulatory process and identify potential challenges early in product development. However, making these resources available and promoting their use has become more difficult, she said. In the past, agency reviewers and teams often participated in healthcare conferences and informal discussions with industry representatives. That engagement has now become more limited amid uncertainty about the administration’s regulatory direction.
“Because of the goal of providing regulatory innovation while at the same time not having a lot of certainty of exactly what that’s going to be, the strategy has been to really say less,” Shick said, describing the approach as a “less is more” strategy.
A key example of this was the annual FDA town hall meeting track at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference, the largest gathering in interventional cardiology. For years, the FDA regulators directly responsible for reviewing innovations in cardiology would speak and have open discussions with cardiologists and industry at the town hall to share ideas and gain clarity in policy or what bar should be set reviewing for new technologies. Despite the FDA under the Trump administration initially making bold claims about "radical transparency" in all its FDA press releases, there were no FDA representatives at the TCT town hall meeting in 2025.
Updates to the FDA website and news releases also slowed noticeably in 2025 under the new administration, providing less information rather than greater transparency.
She said the reduced communication has created challenges for both transparency and innovation. Companies developing AI-enabled medical technologies need to understand regulatory expectations as they design products, generate clinical evidence and prepare submissions for FDA review. But without consistent communication, developers may try to infer regulatory expectations from the products already available on the market. Shick cautioned against relying on that approach.
“What I’ve seen a lot of is folks using the market landscape as a regulatory litmus test,” she said. “If you brought your pre-submission to FDA, they might say something completely different about your product.”
That uncertainty can complicate development strategies, particularly in digital health, where technologies and applications are evolving rapidly.
Staffing and organizational changes
Shick said the changes in communication have extended beyond digital health and reflect broader challenges across the agency. She also pointed to staff attrition and changes affecting where employees are expected to work. In her own case, she said she was not directly affected by cuts to her team, but was permanently working remotely from Boulder, Colorado, when the administration pushed employees to work from the FDA’s main campus in Silver Spring, Maryland.
She said employees based at the main campus were better positioned under that arrangement, illustrating how changes to workplace policies can affect staff differently.
The broader concern, she said, is that reduced engagement and staffing changes could limit the agency’s ability to share expertise with the healthcare technology sector at a time when companies are seeking clarity on how new products will be evaluated.
Potential return to transparency
The administration has emphasized transparency and efforts to accelerate AI adoption in healthcare. However, Shick said the FDA’s reduced public engagement has made it harder for industry to understand how regulatory policy is evolving. She expressed hope that the agency will return to more frequent publication of guidance and greater engagement with medical technology developers, clinicians and professional societies.
“I’m really hopeful that we’re going to see a change on the horizon that will include the publishing of more guidance, more engagement with industry,” she said.
Shick added that the desire for greater communication remains within the agency, even if employees have been limited in their ability to engage publicly.
“I think a lot of this thinking exists within the agency,” she said. “It’s really just waiting for that opportunity for perhaps the administration or otherwise leadership to be comfortable opening the dialogue as it used to be.”
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]