FDA preemption
FDA preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding products approved by the Food and Drug Administration (FDA).[1] It has been a highly-contentious issue. In general, consumer groups are against it, but the FDA and pharmaceutical manufacturers are in favor of it and argues that the FDA should set both the floor and the ceiling for drug regulation.
Michigan is the only state that voluntarily applies FDA preemption to its own state tort law through a regulatory compliance defense, but the law has been controversial and efforts to repeal it were underway in 2009.[2]
Relevant cases
- Riegel v. Medtronic, Inc. (2008): The US Supreme Court ruled that manufacturers of FDA-approved devices are protected from liability under state laws.
- Wyeth v. Levine (2009): The U.S. Supreme Court ruled that Vermont tort law was not preempted.
See also
References
- Glantz, Leonard H.; Annas, George J. (May 2008). "The FDA, Preemption, and the Supreme Court". New England Journal of Medicine. 358 (18): 1883–1885. doi:10.1056/NEJMp0802108. ISSN 0028-4793. PMID 18450601.
- When and How to Defer to the FDA: Learning from Michigan's Regulatory Compliance Defense Michigan Telecommunications and Technology Law Review, Vol. 15, p. 565, 2009.
External links
- Pharmaceutical Research and Manufacturers of America's official statement in support of FDA preemption.
- A statement against FDA preemption
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.