Allergen, Inc., the maker of Botox Therapeutic, has agreed to plead guilty and pay $600 million, following the criminal and civil accusations that it was actively promoting Botox for “off-label” uses between 2001 and 2008.
The criminal information filed indicates that Allergen substantially increased its efforts to market the Botox for off-label purposes, helping doctors to bill Medicaid and other health providers for the injections not covered by Botox’s limited FDA approval. Allergen also “conducted detailed audits of doctors’ billing records to demonstrate how they could make money by injecting Botox, and operated the Botox Reimbursement Hotline, which provided a wide array of free on-demand services to doctors for off-label uses,” among other illegal activities.
“The Food, Drug and Cosmetic Act protects the public from drugs and biologic products that are not proven to be safe and effective. When drug companies make unsubstantiated and misleading statements about their products, they undermine the Act’s protection of public health,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice.
As a result of the three qui tam civil lawsuits filed against Allergen under the False Claims Act, the five whistleblowers involved will receive $37.8 million from the federal portion of the settlement.