Allergan, Inc. has admitted to attempting to market and sell Botox for unapproved uses. There has been a criminal investigation into Allergan’s marketing activities for the product Botox. Prosecutors report that the marketing was aimed at increasing off label sales as a treatment for headaches, spasticity, pain and cerebral palsy.
Based on the allegations within the lawsuit, as a part of their shady marketing practices the company trained doctors how to bill for using Botox for unapproved uses and set up a Reimbursement hotline to help doctors get reimbursed for using Botox for unapproved uses.
The settlement of the investigation includes an admission of guilt by Allergan, Inc. a criminal fine of $375 million and a $225 million civil settlement to the federal government. The civil settlement resolves the allegations that Botox has induced doctors to trick the government into paying for the use of Botox for non-sanctioned uses. The company has also agree to a 5 year corporate integrity agreement with the government to ensure through independent audits and monitoring that the company is following the federal drug marketing regulations and rules.
At this time the guilty plea by Allergan is a misdemeanor, if there are similar infractions in the future it would be considered a felony and the U.S. Department of Health and Human Services would remove all of the company’s products from the market and from all government health plans. While everyone would love to see a product that could significantly reduce the problems caused by birth injuries such as cerebral palsy the safety of the patients should be of the utmost importance. This means that all drugs should be approved by the FDA and used in the method intended.
