IRVINE, Calif. (Mealey's) - Allergan Inc. said Sept. 1 that it will plead guilty to a federal misdemeanor charge related to off-label marketing of Botox and will pay a total of $600 million to the federal government in criminal and civil penalties.
In addition, Allergan said it will dismiss its federal lawsuit challenging the federal government's prohibition against providing information about off-label uses of drugs (Allergan, Inc. v. United States of America, et al. (No. 09-1879, D. D.C.).
The U.S. Justice Department held a press conference about the settlement.
According to Allergan, it will plead guilty to one charge of misbranding Botox between 2000 and 2005 and pay a $375 million criminal fine. In addition, Allergan said it will pay the government $225 million to resolve a False Claims Act lawsuit.
The company said both actions take place in the U.S. District Court for the Northern District of Georgia. No cases had been docketed as of Sept. 1.
In addition, Allergan said it entered into a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.
The company said the Georgia criminal and civil actions concern Allergan's marketing of Botox for off-label uses such as headache, pain, spasticity and juvenile cerebral palsy.
In the District of Columbia action, Allergan sought to enjoin the Food and Drug Administration from prohibiting the company from giving "truthful" information to health care practitioners about off-label uses of Botox.
Botox is botulinum toxin A and was initially approved to temporarily paralyze certain facial muscles that create frown lines. It was subsequently approved to treat muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.
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