Allergan, DOJ Settle Botox Investigation

Allergan has reached a resolution with the U.S. Department of Justice (DOJ) regarding the previously reported government investigation into Allergan’s past U.S. sales and marketing practices relating to certain therapeutic uses of Botox.

Allergan has been cooperating with the government in a multi-year investigation in Atlanta, GA, regarding the use of Botox for certain therapeutic treatments.

Allergan has agreed to plead guilty to a single misdemeanor “misbranding” charge covering the period 2000 through 2005 and pay to the government $375 million.

As part of its plea, Allergan has agreed that between 2000 through 2005, its marketing of Botox resulted in intended uses for the therapeutic treatment of headache, pain, spasticity and juvenile cerebral palsy. These uses were off-label during the relevant time frame and thus the labeling for Boox did not bear directions for these intended uses, resulting in the product being misbranded.

In addition, Allergan has agreed to pay $225 million to resolve civil claims asserted by DOJ under the civil False Claims Act.

The civil settlement is an element of a global settlement that Allergan believes is in the best interest of its stockholders, however the drug maker says it denies liability associated with these civil allegations and does not believe there is merit to them factually or legally.