FDA Preemption

FDA Preemption

FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA (at least under the Bush Administration) and pharmaceutical manufacturers are in favor of it.

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.

External links

* [http://www.phrma.org/news_room/press_releases/phrma_statement_on_fda_preemption/] The Pharmaceutical Research and Manufacturers of America's official statement in support of FDA preemption.
* [http://www.epimetrics.com/topics/one-page?page_id=337&topic=Commentary&page_topic_id=9] A statement against FDA preemption.


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