ネイサン・ビーバーとカイル・ファゲットが、医療・ライフサイエンス分野におけるFDAと州規制当局について議論する

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.’”

「歴史的に、FDAはゴールドスタンダードと見なされ、製品が販売可能か、承認に値する安全性と有効性を備えているかの最終的な判断機関でした」とビーバーは付け加えた。「しかし、将来はそうした世界が存在しない可能性もあると私たちは認識しています」

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