Botox maker Allergan Inc. agreed to pay $600 million and plead guilty to a misdemeanor charge to settle a federal investigation of its marketing practices, AFP reports.
The company will pay the government $375 million for illegally marketing Botox to treat headaches, pain, muscle stiffness, and juvenile cerebral palsy between 2000 and 2005. None of those uses had been approved by the U.S. Food and Drug Administration at the time, though some have since been approved or are being considered now.
According to Assistant Attorney General Tony West, Allergan illegally ”paid kickbacks to induce physicians to inject Botox for off-label uses.”
“Allergan also taught doctors how to bill for off-label uses, including coaching doctors on how to miscode Botox claims, leading to millions of dollars of false claims being submitted to federal and state government programs like Medicare and Medicaid,” he said.
Allergan will pay another $225 million to settle civil charges of promoting off-label uses of Botox. The settlement will be divided between federal and state health insurance programs such as Medicare and Medicaid. The company, however, admitted no wrongdoing with regard to the civil allegations.
The settlement ends a two-and-a-half year investigation that some analysts say has slowed FDA approval of the medicine to treat migraines, Bloomberg News reports.
Douglas Ingram, Allergan executive vice president, said the “settlement is in the best interest of our stockholders.”
Separately, the FDA sent Baxter International Inc. a warning letter for distributing promotional materials that exaggerated the benefits of Aralast, a drug prescribed for patients at risk for lung disease, BusinessWeek reports.
