Customized Medicine and the Limits of Federal Regulatory Power

Anna Laakmann · 19 Vand. J. Ent. & Tech. 2

Abstract

The Food and Drug Administration (FDA) plays a dominant role in setting national policy and standards for the biomedical industry. Yet there are significant statutory constraints on the agency’s power. The FDA’s main implementing statute, the Federal Food, Drug, and Cosmetic Act (FDCA), bounds the scope of the FDA’s regulatory authority. The FDCA cabins FDA power in two important ways: (1) with a few notable exceptions, the FDA lacks power to regulate local activities that are not directly connected to interstate commerce, and (2) the agency may regulate product manufacturers, but not service providers. The FDA has long grappled with the limits of its authority to regulate conduct that encompasses the practice of medicine or the practice of pharmacy, such as physician off-label prescribing and drug compounding. These tensions will intensify as the life science industry evolves from a mass-market distribution scheme to a more customized, service-oriented business model. Autologous stem cell therapies and 3D-printed drugs and devices are two prominent examples of medical innovation that may evade the FDA’s purview. Sophisticated, organized patient advocacy groups that develop and share individualized treatments further expose the limits of the FDA’s statutory authority. These technological and social changes in medical product development and dissemination raise profound questions about the FDA’s future place within our contemporary healthcare regulatory system.