Allergan, Inc. Wednesday said it has agreed to pay $600 million in criminal and civil penalties and plead guilty to one misdemeanor count of “misbranding” its drug BOTOX® as part of a global settlement (pdf) with the federal government over off-label uses of the drug.
As part of the plea deal, the Irvine, Calif.-based drug company agreed to drop its First Amendment legal action against the U.S. government. This action, filed last fall, contended that the government’s legal position — that it’s a crime for a drug company to communicate truthful information to physicians about off-label uses of its products — violates the First Amendment and is inconsistent with the Federal Food, Drug & Cosmetic Act.
