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. Allergan "paid kickbacks to induce [physicians] to inject Botox for off-label uses and Allergan also taught doctors how to bill for off-label uses, including coaching doctors how to miscode Botox claims leading to millions of dollars of false claims being to submitted to federal and state programs," Assistant Attorney General Tony West said.
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