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Allergan, Department of Justice reach agreement over sales and marketing issues related to Botox
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IRVINE, Calif. — Allergan has reached a comprehensive legal settlement with the U.S. Department of Justice over the sales and marketing of Botox, the company announced in a press release.
The global settlement covers criminal and civil actions concerning off-label marketing of Botox (botulinum toxin type A).
"This settlement is in the best interest of our stockholders as it resolves all matters at issue in the investigation, avoids substantial costs of litigation, as well as the substantial risks to Allergan associated with government enforcement action in these matters, and permits us to focus our time and resources on productively developing new treatments for patients and the medical community," Douglas S. Ingram, executive vice president of Allergan, said in the release.
Allergan agreed to enter a guilty plea to one misdemeanor charge of misbranding and pay the federal government $375 million. The government said labeling for Botox did not include adequate directions for off-label or "intended" uses of Botox for headache, pain, spasticity and juvenile cerebral palsy from 2000 to 2005.
Botox has since been approved by the U.S. Food and Drug Administration for treatment of increased muscle stiffness in the elbows, wrists and fingers of adults with upper limb spasticity and is under review for treatment of chronic migraine.
Allergan also agreed to remit $225 million to settle civil claims filed under the civil False Claims Act. However, the company said the allegations lacked legal and factual merit.
The settlement required Allergan to dismiss a First Amendment lawsuit in which the company sought a ruling that it could share valid scientific information with the medical community to help physicians study the benefits and risks of using Botox off-label to treat certain types of spasticity.
Allergan also entered a Corporate Integrity Agreement with the Office of Inspector General of the U.S. Department of Health and Human Services. The company agreed to strictly monitor and maintain compliance with training, auditing, education and disclosure standards for 5 years. The firm also agreed to undergo a third-party assessment of corporate compliance measures, according to the release.