- About
- Journal Archives
- Symposium
- Blog
- News
- Publish
- Resources
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.
Recent Blog Posts
- Will the Angels Face Liability for the Death of Tyler Skaggs?
- A Different Kind of Piracy: North Carolina Claims Immunity from Copyright Infringement in Dispute over Queen Anne’s Revenge
- The Homegrown Player Rules in the MLS
- Why Data Portability Promotes Competition
- A Hot Rod or Just a Fraud?
- The Death of § 2(a) and the Ascent of Native American Trademarks
Blog Archives
Tags
advertising antitrust Apple books career celebrities contracts copyright copyright infringement courts creative content criminal law entertainment Facebook FCC film/television financial First Amendment games Google government intellectual property internet JETLaw journalism lawsuits legislation media medicine Monday Morning JETLawg music NFL patents privacy progress publicity rights radio social networking sports Supreme Court of the United States (SCOTUS) technology telecommunications trademarks Twitter U.S. ConstitutionBlogroll
US Government Websites