Botox maker agrees to pay $600 million for misbranding

The Associated Press: "Allergan Inc., the maker of wrinkle-smoothing Botox, has agreed to pay $600 million to settle a yearslong federal investigation into its marketing of the top-selling, botulin-based drug. The Justice Department and the company said Wednesday in a statement it will plead guilty to one misdemeanor charge of 'misbranding,' in which the company's marketing led physicians to use Botox for unapproved uses. Those included the treatment of headache, pain, spasticity and cerebral palsy in children. Companies are prohibited from promoting drugs for unapproved, or 'off-label,' uses. Allergan said it will pay $375 million in connection with the plea, which includes the forfeiture of $25 million in assets. Additionally, the company will pay $225 million in civil fines — $210 million to the federal governments and the rest to several states — related to the investigation, although the company denies liability for the civil claims" (Perone, 9/1).

CBS News: "While drug maker Allergan has pled guilty to illegally marketing its drug Botox for unapproved uses such as migraines, CBS News has learned that the manufacturer has been busy testing the drug overseas for the same ailments. … Allergan is recruiting patients and running these trials in countries such as India, Poland, Russia, Egypt, Lebanon, Turkey and Serbia" (Strickler, 9/1).

Reuters: "The U.S. Department of Justice will continue to 'aggressively pursue' pharmaceutical companies that illegally market drugs for uses that have not been approved by health regulators, a top agency official said on Wednesday" (Pelofsky, 9/1).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.