Allergan Pleads Guilty for Off-Label Promotion of Botox®


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Allergan Inc., a pharmaceutical manufacturer, is pleading guilty and agreeing to pay $600 million after being charged for unlawfully promoting and using its biological product, Botox® Therapeutic, for off-label uses not approved by the U.S. Food and Drug Administration (FDA).  When companies submit a drug to the FDA under the Food, Drug, and Cosmetic Act (FDCA) they must specify the use of the biological product.  The FDA can then approve the product as safe and effective for the specified uses only.  Any other use, known as off-label use, is illegal as it is not approved as safe and effective by the FDA and can endanger patients using the drug.  Allergan marketed Botox® for off-label uses which were not specified as safe and effective by the FDA.  The five whistleblowers in the case—Dr. Amy Lang, Charles Rushin, Cher Beilfuss, Kathleen O’Conner-Masse, and Edward Hallivus—will receive $37.8 million.

Botox® was approved several times since 1989 for numerous uses, including treatment of “strabismus (cross eyes),” “blepharospasm (involuntary eyelid contraction),” “cervical dystonia (involuntary neck muscle contraction, “ “primary axillary hyperhidrosis (excessive underarm sweating),” “adult upper-limb spasticity.” While Botox® was approved and deemed safe and effective for these uses, Allergan marketed the product for other uses as well, including pain, headaches, spasticity, and juvenile cerebral palsy. Allergan used the approval to treat cervical dystonia with Botox® to stretch the uses of the drug to headaches and pain.  The company claimed that cervical dystonia was “’underdiagnosed’” and that even if the doctor saw no visible signs of cervical dystonia it could be diagnosed by headache and pain.  “According to the criminal information, Allergan made it a top corporate priority to maximize sales of Botox® for such off-label uses.”

According to Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, the FDCA is meant to protect consumers from products that are not deemed to be safe and effective.  He explains that by breaching the FDCA, drug companies “‘undermine the Act’s protection of public health’” and “’violate the Act for their own gain.’”

Allergan also used doctors who are known to prescribe patients with medications with off-label drug uses.  The company taught doctors how to bill federal health care programs by miscoding claims for off-label uses and how they can make more money by using Botox® to treat cases (and therefore instructed them to use inject more Botoxâ).  Allergan also directed workshops about off-label usage of drugs.  The company even lobbied government health care programs to try to convince them expand their coverage to off-label usage of drugs.

For such off-label usage and promotion, Allergan will pay $600 million.  The $600 million includes $375 for the criminal fine and forfeiting of assets and  $225 million for the federal government and the states for false claims.  Of this $225 million, $210,250,000 will go to the federal government ($37.8 of which goes to the whistleblowers) and $14,750,000 will go to participating states. The $225 million covers the false claims submitted to “Medicare, Medicaid, TRICARE,, and to the Federal Employees Health Benefit Program, the Department of Veteran’s Affairs, and the Department of Labor’s office of Workers’ Compensation Programs.”  These false claims included billing for the off-label usage of the drugs which were not “medically accepted and therefore not covered by federal health care programs.” According to Sally Yates, U.S. Attorney for the Northern District of Georgia, this recovery is important because, “’Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective.’”

Allergan also breached its Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of the Inspector General (HHS-OIG) by using Botox® for off-label reasons.  The CIA demands that someone on Allergan’s Board of Directors review the company’s compliance program yearly and report on its effectiveness.  Furthermore, the senior executives of Allergan are supposed to oversee their departments to ensure that they are compliant with federal health care programs.  Doctors are supposed to be informed about the CIA, and information about the payment of doctors is supposed to be made available to the public on Allergan’s website.  Allergan may be excluded from federal health care programs for breaching the CIA.

Allergan is pleading guilty and will pay $600 million if the U.S. District Court finalizes the sentence.

This case does not affect Botox® Cosmetic.

Source: Office of Public Affairs, United States Department of Justice. “Allergan Agrees to Plead Guilty and Pay $600 Million to Resolve Allegations of Off-Label Promotion of Botoxâ.” 1 Sept. 2010.



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