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34) Because most states' food laws focused primarily on adulterated food, there were no regulations aimed at preventing food misbranding.
But the Second Circuit's opinion also discussed the First Amendment problems with FDA's off-label marketing regulations in a broader context and indicated that they would not pass muster even if prosecutions were properly characterized as misbranding cases and brought against senior company executives.
9 million settlement regarding its off label marketing of Rapamune and pled guilty to a misbranding violation under the FDCA.
45) It concluded that "any right Caronia had as Xyrem's sales representative to express as commercial speech the truthful promotion of Xyrem's off-label uses is not unconstitutionally restricted by the misbranding provisions" of the FDCA.
Both the majority and the dissent referenced the FDA's misbranding prohibition.
Wyeth pleaded guilty to one count of misbranding Rapamune, a kidney transplant drug, for unapproved uses, including other transplant procedures, the Justice Department said in a statement today.
In December, the 2nd Circuit called into question the legal underpinnings of many such drug misbranding cases when it vacated the conviction of pharmaceutical sales rep Alfred Caronia for off-label but truthful promotion, contending it violated his First Amendment rights.
But criminal and regulatory penalties for product misbranding or adulteration are by no means limited to corporate defendants.
Although none of the officers were directly involved with the activities that gave rise to the charges of misbranding, they were subject to misdemeanor convictions under Section 333(a)(1) of
The bill would increase the penalties associated with introducing or receiving adulterated or misbranded food, or causing adulteration or misbranding, from up to three years in prison to up to 10 years in prison for intentional violations.
of Quincy, Massachusetts, was convicted of misbranding seafood, a violation of the Lacey Act, a federal wildlife statute, and the economic fraud section of the Food, Drug and Cosmetic Act.
The companies also agreed to pay more than $24 million in penalties as they pleaded guilty to misbranding a material used without approval in spinal surgeries.
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