Abstract
Despite newfound attention to how artificial intelligence (AI) may accelerate pharmaceutical development, federal regulators may find that current statutes are ambiguous or silent about their applicability to AI-based drug design and manufacturing methods. This poses a serious problem in the era of Loper Bright and the Major Questions Doctrine. As federal agencies struggle to adjust to courts’ growing demand for Congress to craft clear, explicit, and express delegations of authority, this note develops a statutory framework in which the Food and Drug Administration (FDA) would have more flexibility to regulate the use of AI in advanced drug manufacturing. Guided by lessons from AI-adjacent statutes and international regulatory schemes, this note proposes amendments to 21 U.S.C. §§ 355, 356, and 360 that would undergird said framework.
Recommended Citation
AJ Tsang,
Enhancing 21 U.S.C. §§ 355, 356, and 360 to Encompass Artificial Intelligence-Based Drug Design and Manufacturing Methods,
31
Mich. Tech. L. Rev.
166
(2024).
Available at:
https://repository.law.umich.edu/mtlr/vol31/iss1/4
Included in
Artificial Intelligence and Robotics Commons, Food and Drug Law Commons, Pharmaceutics and Drug Design Commons, Science and Technology Law Commons
