|Shire Pharmaceuticals LLC has agreed to pay $56.5 million to settle allegations that it overstated the efficacy of several of its drugs, including the attention-deficit treatment Adderall XR, the Department of Justice said Wednesday.|
Shire Pharmaceuticals, a unit of Dublin-based drugmaker Shire PLC, allegedly violated the False Claims Act from 2004 to 2007 by promoting that Adderall could "normalize" recipients, making them indistinguishable from non-ADHD peers.
Shire didn't have clinical data to back up the claims, the Department of Justice said. Shire also said in its marketing that Adderall would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease, the DOJ alleges.
"Shire cooperated throughout this investigation and, in advance of this settlement, began to correct its marketing activities," said U.S. Attorney Zane David Memeger in a statement Wednesday.
"We are pleased to have reached a resolution and to put this matter behind us," Chief Executive Flemming Ornskov said. "The company has had, and will continue to have, a comprehensive compliance program and internal controls to ensure we comply with applicable laws and regulations."
Shire hasn't admitted wrongdoing in connection with the settlement, according to the company's statement.
The pact resolves one outstanding issue ahead of Shire's planned $54 billion acquisition by AbbVie Inc.
The allegations stem from...