Solicitor General argues for preemption
Pharma Compliance Alert, January 9, 2008
In an opinion posted on the Department of Justice Web site, U.S. Solicitor General Paul Clement states FDA approval of a drug's label preempts state law.
In the case of Wyeth v. Diane Levene, the Vermont Supreme Court ruled that a patient could sue Wyeth over the labeling of Phenergan, an anti-nausea drug. Clement said the petitioners' claims are "impliedly preempted" by the Food, Drug, & Cosmetic Act and the Vermont Supreme Court's "contrary conclusion rests on its mistaken view that an FDA regulation allow[s] unilateral changes to drug labels whenever the manufacturer believes [the changes] will make the product safer."
Clement added that even though the Vermont Supreme Court's decision is wrong, it does not require plenary review at this time.
Click here to read Clement's complete opinion.
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