The Justice Department announced an American pharmaceutical manufacturer Allergan Inc. has agreed to plead guilty and pay $600 million to resolve its criminal and civil liability arising from the company’s unlawful promotion of its biological product, Botox® Therapeutic, for uses not approved as safe and effective by the Food and Drug Administration (FDA).
Brian D. Lamkin, Special Agent in Charge, FBI Atlanta, Sally Yates, U.S. Attorney, Northern District of Georgia; Tony West, Assistant Attorney General Civil Division U.S. Department of Justice; Daniel Levinson, Inspector General, U.S. Department of Health & Human Services; and Margaret Hamburg, M.D., FDA Commissioner of Food & Drugs sharing results from the collaboration of the Department of Justice and the Department of Health and Human Services and their promise to crack down on health care fraud.
Allergan, a pharmaceutical manufacturer, agreed to pay $600 million to resolve serious criminal and civil fraud allegations of promoting the drug Botox for uses that were not safe nor approved by the FDA. Allergan also paid kickbacks to doctors for off-label use of the drug and taught them how to bill for off-label uses leading to millions of dollars of false claim submissions to federal and state programs.
Sally Quillian Yates, U.S. Attorney, Northern District of Georgia listens as Assistant Attorney General Tony West discusses the consequences of fraud.
“Fighting health care fraud is a top priority for the Obama Administration, for Attorney General Eric Holder and for me.”… “These are not victimless crimes. When our public health care programs are burdened with fraudulent charges, it drives the cost of health care up for all of us – consumers pay more in premiums; companies pay more to cover their employees. And when a pharmaceutical manufacturer violates the integrity of the drug approval process established by Congress and the FDA by paying kickbacks to encourage the off-label use of an unapproved drug, that not only undermines the judgments of health care professionals; it also threatens to put patients’ health and safety at risk.”
Daniel R. Levinson, Inspector General of the U.S. Department of Health and Human Services warns of the dangers of off-label promotion and kickbacks.
“Fraudulent marketing of drugs through off-label promotion or kickbacks to prescribers undermines the protections afforded by the drug approval process and medical decision-making. As a result of this settlement, [HHS] OIG will oversee a Corporate Integrity Agreement with Allergan that increases the transparency of Allergan’s interactions with physicians and helps to ensure the company’s future compliance and accountability.”