Last month, drug company Allergan, Inc. agreed to pay $225 million to resolve civil allegations that it unlawfully promoted its drug Botox® Therapeutic for unapproved uses and that it paid illegal remuneration to health care providers to induce them to prescribe the company’s products. In addition, the company agreed to pay a $375 million criminal fine and to plead guilty to a misdemeanor charge of introducing this misbranded drug into interstate commerce. Earlier this week, the court approved Allergan’s plea agreement.

Prior to the sentencing hearing, the government filed a sentencing memorandum, detailing the allegations. According to the government’s memo, Allergan entered into a co-promotion agreement with a pharmaceutical company that had an FDA-approved headache drug, with the underlying goal of promoting Botox to neurologists who were customers of the other company.

“As a result of this unlawful off-label marketing scheme, Botox sales skyrocketed,” the court document said. By 2007, for example, the medical uses of Botox had annual sales of more than $500 million, with up to 80 percent from unapproved uses, primarily headache, pain and spasticity, the government’s document said.

The government began investigating Allergan’s marketing efforts after Nolan & Auerbach’s clients filed a qui tam action against the company.

For more information about qui tam law and pharmaceutical fraud, contact Nolan and Auerbach, PA.