FDA in flux: Highlights from DLA Piper’s 2025 Product Liability Symposium panel

DLA Piper’s 2025 Product Liability Symposium featured a panel discussion on key considerations related to shifting Food and Drug Administration (FDA) regulation.

The conversation featured in-house counsel Neena Patil (Executive Vice President and Chief Legal Officer, Jazz Pharmaceuticals), Partner Jae Kim (Philadelphia, Washington, DC), Partner Sharon Mayl (Washington, DC), Of Counsel Christopher Gismondi (New York), and moderated by DLA Piper Associate Megan Kinney (San Diego). The panelists explored a central question: How can in-house counsel stay ahead in an evolving regulatory landscape while adapting to the FDA’s evolving priorities?

We provide a summary of the panelists’ insights below.

Leadership overhauls and policy curveballs

The panel began with a discussion of the factors contributing to today’s regulatory uncertainty. Sharon noted the impacts of significant leadership turnover at the FDA, Department of Health and Human Services, and Centers for Disease Control and Prevention, along with a major reorganization of FDA’s Human Foods Program. These developments have prompted the Trump Administration to revise its regulatory approach within the FDA.

Policy is now shaped through a mix of traditional tools (eg, notice-and-comment rulemaking), as well as non-traditional tactics, including private meetings, expert panels, far-reaching Executive Orders, and social media. The “Make America Healthy Again” initiative has also taken a prominent role, with a focus on chronic disease and increased state-level activity.

The bottom line: As FDA’s priorities shift, the path forward may be difficult to predict.

Spotlight on FDA’s approach to AI and ultra-processed foods

Jae highlighted FDA’s introduction of its artificial intelligence (AI) tool, Elsa, and accompanying industry guidance on AI uses, noting both opportunities and challenges for companies eager to innovate. Sharon and Neena addressed considerations for implementing AI under evolving rules.

Sharon also discussed the complexities of navigating FDA and state activity around ultra-processed foods, while Chris highlighted the growing volume of litigation in this area.

The panel further addressed the impact of staffing reductions at FDA and the implementation of new approval procedures. These changes have contributed to delays and affected the predictability of agency meetings and informal collaboration.

Across the board, companies are navigating shifting policies around transparency, such as the release of complete response letters, as well as the decrease in FDA guidance documents.

How to engage with regulators amid change

The panelists noted that companies should consider their approach to engagement with regulators. Neena and Jae emphasized the value of a risk-based approach – such as knowing when to push back, when to collaborate, and when to involve expert counsel. Sharon stated that many food policy decisions are now driven by senior political leadership, underscoring the importance of evaluating engagement options, whether individually or through trade associations.

Chris highlighted the key role of trade associations in representing industry interests when disputes arise. He suggested that delaying engagement may be appropriate when traditional pressure tactics no longer work.

Looking ahead: Staying nimble and informed

FDA is evolving, and companies are encouraged to stay alert. To thrive in this changing environment, organizations should consider closely monitoring developments, adapting compliance strategies, and maintaining proactive engagement with regulators and industry peers.

Learn more

Register your interest to join us in-person at the 2026 Product Liability Symposium in Philadelphia, where we will continue the conversation on navigating emerging trends in product liability and class action litigation. For more information regarding shifting FDA regulation, please contact the authors.