FDA suffers setback in pedigree suit brought by secondary wholesaler

The U.S. Court of Appeals for the Second Circuit has affirmed the granting of a preliminary injunction by the District Court in the RxUSA et al v. FDA suit. The suit was filed by a secondary wholesaler, RxUSA, and others against the Food & Drug Administration over its requirement for drug pedigree. It's not clear yet whether FDA will seek further review by the U.S. Supreme Court. Even if FDA chooses not to go that route, the case still has to be litigated. Lawyers for RxUSA are preparing for discovery and trial.

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