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Presenting themselves as victims of government overreach, the companies argue that their First Amendment rights are being violated: "FDA's unlawful actions already have harmed Plaintiffs and threaten greater harms in the future by restricting Plaintiffs' ability to modify their product labels without FDA preauthorization and by chilling and restricting protected speech." Although the case does not involve the federal warning labels that have been required for decades, it makes the puzzling argument that the FDA guidelines also violate the industry's Fifth Amendment rights against self-incrimination

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Pharmacodynamics 45, S53S54