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.’”
"역사적으로 FDA는 최고의 표준으로 여겨져 왔으며, 실제로 제품의 판매 가능 여부와 승인에 대한 안전성과 효과에 대한 최종 결정권자로 여겨져 왔습니다."라고 Beaver는 덧붙입니다. "그리고 우리는 미래에는 그런 세상이 존재하지 않을 수도 있다는 것을 알았습니다."
