Implied Preemption And Medical Devices

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Was anyone else out there struck, like we were, that the Court described the preemptive FDA action it recognized in Pliva, Inc. v. Mensing, ___ U.S. ___, 2011 WL 2472790 (U.S. June 23, 2011), in terms of “equivalence”? Here’s what we mean:

“Under this law [Hatch-Waxman], “generic drugs” can gain FDA approval simply by showing equivalence to a reference listed drug that has already been approved by the FDA. This allows manufacturers to develop generic drugs inexpensively, without duplicating the clinical trials already performed on the equivalent brand-name drug.”

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