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] 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 is also being 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.[2]
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.[3]
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
- {{Cite journal |last1=Glantz |first1=Leonard H. |last2=Annas |first2=George J. |date=May 2008 |title=The FDA, Preemption, and the Supreme Court |url=http://www.nejm.org/doi/abs/10.1056/NEJMp0802108 |journal=New England Journal of Medicine |language=en |volume=358 |issue=18 |pages=1883–1885 |doi=10.1056/NEJMp0802108 |pmid=18450601 |issn=0028-4793}
- Grossi, P. "FDA preemption of conflicting state drug regulation and the looming battle over abortion medications".
{{cite journal}}: Cite journal requires|journal=(help) - 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