Shire Plc, which is in the process of being acquired by AbbVie Inc, has agreed to pay $56.5 million to resolve allegations of making false claims in the marketing of its ADHD drug Adderall XR and other medicines, the U.S. Justice Department said on Wednesday.
The settlement involved charges that Ireland-based Shire, between January 2004 and December 2007, promoted its extended release Adderall with claims of superiority over rival medicines that were not supported by clinical data, the Justice Department said.
The company was also accused of promoting the drug for unapproved uses and of making other false claims not supported by data, such as that Adderall XR would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents, and sexually transmitted disease.
The settlement also resolves allegations that, between February 2007 and September 2010, Shire sales representatives allegedly made false and misleading statements about the efficacy and abuse liability of its other attention deficit hyperactivity disorder (ADHD) medicine Vyvanse to state Medicaid formulary committees and doctors.
"Shire cooperated throughout this investigation and, in advance of this settlement, began to correct its marketing activities," Zane David Memeger, U.S. Attorney for the Eastern District of Pennsylvania, said in a statement.
The company said it has not admitted any wrongdoing in connection with the agreement.
In addition to the $56.5 million settlement, Shire said it will pay $2.9 million to resolve a civil suit filed by the state of Louisiana over marketing practices that allegedly violated state law.
As part of the larger settlement, Shire agreed to enter into a five-year corporate integrity agreement with the Office of Inspector General for the Department of Health and Human Services.
"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 Chief Executive Flemming Ornskov said in a statement.
In July, U.S. drugmaker AbbVie said it would acquire Shire for about $54 billion.
