Nathan Beaver and Kyle Faget Discuss FDA, State Regulatory Authority in Health Care and Life Sciences Issues

Foley & Lardner LLP partners Nate Beaver and Kyle Faget joined The Vanguard Network to discuss how health care and life sciences executives are navigating contrasting regulatory processes across the state and federal levels.

During the discussion, titled “The FDA and State Governments. Is the FDA the Final Arbiter?” Beaver and Faget addressed how shifting federal priorities are impacting the approval process, the growing regulatory variations between states, key challenges in pharmaceutical marketing and AI-driven products, and circumstances in which medical devices may be outside of U.S. Food and Drug Administration oversight.

Commenting on the evolving regulatory landscape, Beaver noted the influence of Secretary Kennedy, advising that “being aware of what his areas of focus are and how they may impact FDA is critical to understanding the current FDA.”

On the topic of AI-driven products, Faget noted, “the regulatory framework is really set up to address device innovation in discrete increments,” which presents challenges for reframing regulation on rapidly evolving AI technologies.

In a recorded highlight from the discussion, Faget added, “It is really the case that you’ve got states now that are trying to, in the face of a hotly contested political issue, trying to become ‘mini-FDAs.’”

“Historically, FDA has been seen as the gold standard, and really the final arbiter of whether a product can be sold and whether it’s safe and effective for approval,” Beaver added. “And we’ve seen that might not be the world that exists in the future.”

The full episode is available from The Vanguard Network and on SoundCloud.