Food Drug and Cosmetic Act
In U.S. v. Caronia, the court vacated the conviction of a pharmaceutical sales rep for off-label but truthful promotion, contending it violated his First Amendment rights
“There are known knowns; there are things we know we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns–the ones we don’t know we don’t know.”
Pharmaceutical giant Merck & Co. agreed Tuesday to pay $950 million to settle criminal and civil charges surrounding the alleged false promotion of its painkiller Vioxx, which was withdrawn from the marketplace after claims of heart attacks and other injuries surfaced.