Allergan Settles with DOJ Related to the Sales and Marketing of BOTOX

September 1, 2010

By Nisha P. Shah

At the conclusion of a multi-year federal investigation, Allergan Inc. ("Allergan") announced today it has reached a settlement with the U.S. Department of Justice (DOJ) and will pay $600 million to resolve criminal and civil claims related to the sales and marketing of BOTOX (onabotulinumtoxinA).  According to the press release issued by the company, the DOJ alleged that Allergan was marketing BOTOX for the treatment of headache, pain, spasticity, and juvenile cerebral palsy.  During the relevant time of 2000 to 2005, these uses were off-label for which Allergan had not received approval from FDA.  A copy of the DOJ's press release is available here.

According to the Allergan press release, Allergan will plead guilty to a single misdemeanor misbranding charge, which  alleged that the drug product’s labeling did not contain adequate directions for the intended uses.  The misbranding charge is a strict liability offense. Allergan will pay $375 million in criminal penalties to settle the misbranding charge. 

Additionally, Allergan agreed to pay $225 million to settle civil claims under the civil False Claims Act.  Those lawsuit (here, here, and here) were filed in federal court in the Northern District of Georgia under the qui tam provisions of the False Claims Act.  As part of the global settlement, the company entered into a five-year Corporate Integrity Agreement ("CIA") with the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services.  It seems that no criminal or civil charges were brought against individuals in this case.

Notably, the Allergan press release mentions that the Government required Allergan to dismiss its First Amendment case, in which Allergan sought a decision that it could distribute truthful scientific and medical information to healthcare professionals to assist physicians in evaluating the risks and benefits if they decide to use BOTOX for off-label purposes. 

Categories: Drug Development