Corporate Compliance

Allergan will pay $600M for promoting off-label uses of Botox®

Compliance Monitor, September 15, 2010

Pharmaceutical company Allergan Inc. will pay $600 million in fines after pleading guilty to criminal and civil liability claims for promoting Botox® for uses the Food and Drug Administration (FDA) did not approve, according to a Department of Justice (DOJ) press release.

Allergan allegedly exploited one of Botox’s® approved uses, which is to treat cervical dystonia (involuntary neck muscle contraction), by linking it to headache and pain symptoms. Allergan allegedly claimed that physicians could diagnose cervical dystonia based solely on headache and pain symptoms, according to the DOJ.

Allergan participated in several other illegal off-label marketing tactics, including:

  • Holding workshops to teach doctors and their office staff how to bill for off-label uses
  • Conducting detailed audits of doctors’ billing records to demonstrate how they could make money by injecting Botox®
  • Lobbying government health care programs to expand coverage for off-label uses
  • Directing physician workshops and dinners focused on off-label uses
  • Paying doctors to attend advisory boards promoting off-label uses

As part of the civil settlement, Allergan will pay an additional $225 million to the federal government and the states affected to resolve false claims submissions to Medicare, Medicaid, TRICARE, Federal Employees Health Benefit Program, the Department of Veterans’ Affairs, and the Department of Labor’s Office of Workers’ Compensation Programs.

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