FDA Approval as Property: Considerations for Pharma Regulation, Innovation, and Access to Medicines скачать в хорошем качестве

FDA Approval as Property: Considerations for Pharma Regulation, Innovation, and Access to Medicines

Join CIPLIT and the Mary and Michael Jaharis Health Law Institute for "FDA Approval as Property: Considerations for Pharmaceutical Regulation, Innovation, and Access to Medicines", a talk by Ryan Knox (Jaharis Fellow, DePaul Law). Description: FDA approval is the gold standard of drug regulation globally and the key to the pharmaceutical market. Given its significance, some manufacturers have claimed property rights in their FDA approvals, yet the legal status of FDA approval—and the availability of constitutional protections for its holders—remains unsettled. This talk will explore whether FDA approval resembles property under traditional property theories, intellectual property theories, and new property theory. Ultimately, Professor Knox argues that FDA approval is best understood under new property theory and the legitimate claim of entitlement doctrine, similar to other recognized categories of government-created property such as licenses and franchises. Further, Professor Knox will discuss the implications of recognizing FDA approval as property for the FDA’s regulatory authority, pharmaceutical innovation, and patients’ access to medicines. Bio: Ryan Knox is a health law and policy scholar who joined DePaul Law as a Jaharis Faculty Fellow in July 2024. His research focuses on issues of FDA regulation and access to medicines, including drug approval, competition and pricing. Prior to coming to DePaul, Ryan was a postdoctoral fellow at the Harvard-MIT Center for Regulatory Science and a research collaborator with the Program on Regulation, Therapeutics, And Law (PORTAL) at Harvard Medical School and Brigham & Women’s Hospital. His recent research has been published or is forthcoming in the UC Law Journal, Oklahoma Law Review, Journal of Law & the Biosciences, JAMA, JAMA Health Forum, Health Affairs Scholar, and Nature Biotechnology. Ryan earned his BS, magna cum laude, in Health Science from Boston University and his JD from New York University.