Panelists observe FDA sea changes in inspections, manufacturing, and drug & device reviews

Kicking off the FDA-focused panel conversation at Horizons Boston, Lynn Mehler, head of the pharmaceutical & biotechnology regulatory practice and co-head of the life sciences sector group at Hogan Lovells, provided background on FDA's leadership transition, asking the panelists where they have observed changes in agency behavior over the past year. Elizabeth Jungman, partner in the Hogan Lovells pharmaceutical and biotechnology regulatory practice and former head of CDER Office of Regulatory Policy, pointed out that the biggest change at FDA has been in its staffing. Describing the “scattershot” effects of the various programs that incentivized staff to leave even before the reduction-in-force (RIF) was initiated, Jungman noted that the staff reductions were not limited to the functions or offices targeted by the RIFs. There are “pockets” of FDA that look “nothing like” they did six months ago, she described, leaving remaining staff to take on additional work, sometimes outside of their historical areas of expertise.

At FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), Mehler agreed that staff reductions have led to mixed results related to applications for drugs and biological products. Jungman and Mehler agreed that the basics of interacting with the agency have not changed, but that staffing changes and new priorities may affect companies' strategy for agency engagement.

Regarding applications reviewed by FDA's Center for Devices and Radiological Health (CDRH), Lina Kontos, partner in the Hogan Lovells medical device & technology regulatory practice, forecast more opportunities in 2026 to engage with FDA leaders on creative and novel medical products, observing an “appetite for innovation and development” and increased engagement with sponsors in the device center. Although there have been a number of FDA device leaders and review staff that have departed the agency over the past 6 months, the baseline for medical device review is fundamentally operating in the same way as it did in 2024, relying on existing pathways and sound scientific evidence, Kontos said. 

US promotion of onshoring manufacturing

As life sciences companies are increasingly pledging to onshore manufacturing operations in the U.S., Chris Middendorf, senior director in the Hogan Lovells pharmaceutical & biotechnology regulatory practice and former FDA investigator, described some of the layers of complexity involved with technology transfer, which requires the seamless migration of process knowledge, quality systems, and regulatory compliance with FDA rules. Regardless, the panelists agreed, the Trump administration is willing to engage positively with companies that are trying to onshore manufacturing in the U.S. Jungman pointed out that the administration “wants wins on their new policies,” which may present opportunities for companies with plans for domestic facilities.

Sally Gu, senior associate in the Hogan Lovells pharmaceutical and biotechnology practice, described how the administration is using “both carrot and stick” to encourage onshoring manufacturing in the U.S., citing the potential benefits of FDA's newly launched PreCheck program, which is a voluntary initiative designed to promote onshoring by streamlining regulatory oversight and fostering early engagement in manufacturing facility development. FDA recently held a public meeting to obtain feedback on its PreCheck program, which we summarized online here.

FDA inspections & enforcement

Shifting the conversation to survey FDA's manufacturing site compliance regulations, Gu said she has observed increased agency inspections as well as enforcement activity. “We're seeing an uptick in inspections on the device side as well,” Kontos agreed, cautioning: “There's room for innovation, but you still have to follow the rules.”

Kontos further described how FDA is “connecting dots behind the scenes,” which industry has seen in FDA's investigation into biocompatibility data integrity issues and use of directed inspections, among other situations. In addition, Jungman noted that the agency's heightened focus on AI extends to potential uses for compliance and enforcement. As the agency's AI capabilities grow, it may have enhanced capabilities to detect fraud and data integrity issues.

In the drug advertising space, Mehler predicted a sustained hike in FDA enforcement activity against promotional materials that the agency deems to be potentially “misleading,” on top of the thousands of warning letters that FDA has already sent to companies as part of its September direct-to-consumer (DTC) drug advertisement crackdown, which we summarized online here. In addition, Mehler commented on the release of complete response letters (CRLs) by FDA, drawing attention to how both of these actions suggest the administration “is not afraid of getting sued.” Indeed, “this will be an interesting space to watch,” the panelists agreed.

Next steps

The Horizons 2025 event hosted in Boston is part of our global series connecting professionals across offices in Zurich, Tokyo, and the U.S. If you are interested in joining future discussions focused on the intersection of business, regulatory, and political developments affecting the life sciences industry, click here to register, and be sure you are signed up for Our Thinking to receiving daily updates from our team.