(4) The FDCA prohibited misbranding
food and beverages using false or misleading labels to further this goal.
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.
In July 2013, Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc., entered into a $490.9 million settlement regarding its off label marketing of Rapamune and pled guilty to a misbranding
violation under the FDCA.
Both the majority and the dissent referenced the FDA's misbranding
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.
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.
Attorney, and Stryker Biotech, Ard and Whitaker were charged with misbranding
Nichols Institute pleaded guilty to felony misbranding
as part of the criminal case filed against the company and will pay a $40 million fine.