The Department of Justice announced that Allergen Inc. will pay $600 million to resolve a federal probe of how it has marketed Botox, the injectable wrinkle smoother. The company will plead guilty to a single misdemeanor that it misbranded the drug during the period of 2000-2005, making claims for uses not then approved as safe and effective by the FDA. These included “off label” treatments of headaches, pain, spasticity, and juvenile cerebral palsy. At the time, Botox had only been approved for treating various muscle contractions, crossed eyes, and excessive sweating.

The DOJ accused Allergan of promoting Botox for therapeutic uses not approved by the FDA, paying kickbacks to encourage doctors to prescribe it and teaching them how to bill for off-label uses. The resolution includes a criminal fine and forfeiture totaling $375 million. As part of the civil settlement, Allergan has agreed to pay an additional $225 million to the federal government and the states to resolve claims that its unlawful marketing practices caused false claims to be submitted to government health care programs.

As part of today’s resolution, the five whistleblowers who brought the charges to the government’s attention will receive $37.8 million from the federal share of the settlement amount.

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