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FDA preemption is the legal theory in the United States that products licensed or otherwise approved for use by the Food and Drug Administration (FDA) are exempt from various state efforts to preclude their use. It has been raised as a counter to both direct efforts to ban such products, and as a defense against tort claims regarding such products. The doctrine hinges on the assertion of Congressional intent to designate FDA as the national clearinghouse for determinations of the safety of pharmaceutical products, and the Supremacy Clause of the Constitution of the United States placing federal law over state law.
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.
The doctrine has also been raised in connection with the growing efforts of some states to ban or severely restrict the use of the abortion drug mifepristone, in a manner contrary to the regimen set forth by FDA.
Michigan was the only state that voluntarily applied FDA preemption to its own state tort law through a regulatory compliance defense, having enacted this provision in 1995 to draw pharmaceutical companies to the state, but the law was controversial and efforts to repeal it were underway in 2009. In 2023, a bill to repeal the Michigan statute passed both houses of the Michigan state legislature, and was signed into law in December 2023.
FDA preemption has also been raised against direct efforts by states to ban disfavored FDA-licensed pharmaceutical products, as with the failed effort by the state of Massachusetts to ban opioid analgesic Zohydro.
Relevant cases
- Riegel v. Medtronic, Inc. (2008): The U.S. 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.
- Mutual Pharmaceutical Co. v. Bartlett (2013): The U.S. Supreme Court ruled that generic drug manufactures cannot be held liable under state law for not adequately labeling medication when federal law prohibits them from changing the label from the original brand name drug.
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.
- Grossi, P (March 15, 2023). "FDA preemption of conflicting state drug regulation and the looming battle over abortion medications". Journal of Law and the Biosciences. 10 (1): lsad005. doi:10.1093/jlb/lsad005. PMC 10017072. PMID 36938304.
- 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.
- Castronuovo, Celine (November 17, 2023). "Michigan Pharma Shield Law Furthers Debate on FDA Preemption". Bloomberg News.
- King, Jon (December 7, 2023). "Whitmer signs repeal of nation's only immunity law that shielded drugmakers from legal liability". Michigan Advance.
- Lars Noah, "State Affronts to Federal Primacy in the Licensure of Pharmaceutical Products", Michigan State Law Review, Vol. 2016, No. 1 (August 2016).
External links
- Pharmaceutical Research and Manufacturers of America's official statement in support of FDA preemption.
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