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Recent Developments Since <i>Pliva v. Mensing</i>
In PLIVA v. Mensing, 131 S.Ct. 2567 (2011), a 5-4 majority of the Supreme Court held that federal regulations applicable to generic pharmaceuticals preempt state law claims alleging that the manufacturers failed to warn consumers of the drug's risks. Together with Wyeth v. Levine, 555 U.S. 555 (2009), in which the Court allowed failure-to-warn claims to proceed against a manufacturer of brand-name medications, the Court's decisions have been interpreted to establish different preemption rules for generic- and branded-drug makers based on the different obligations these manufacturers face under federal law.
Background
To obtain federal approval to market a new drug, a manufacturer must prove that it is safe and effective and that the proposed label is accurate and adequate, a process involving lengthy and expensive product testing. In contrast, generic drug makers must establish the equivalence of their product to an existing FDA-approved medication (typically, the brand-name version), demonstrating that the generic version has the same active ingredients and effectiveness as the reference drug. Generics must also adopt the same FDA-approved labeling that accompanies the equivalent brand-name version. See Mensing, 131 S.Ct. at 2574-75. This abbreviated FDA-approval process permits generic drugs to be marketed inexpensively, without the same testing and clinical trials required for brand-name medications.
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