Wayne, Pa.-based Shire Pharmaceuticals has agreed to pay $56.5 million to resolve allegations it violated the federal False Claims Act by promoting Adderall XR for uses that were not supported by clinical data and for overstating the effectiveness of the drug, according to the Department of Justice.
Shire manufactures and sells pharmaceuticals, including Adderall XR, Vyvanese and Daytrana, which are all approved for the treatment of attention deficit hyperactivity disorder.
The lawsuit alleged between January 2004 and December 2007 Shire marketed Adderall XR as being clinically superior to other ADHD medications because it would "normalize" its recipients, meaning those who took the drug would be indistinguishable from others who did not have ADHD, which was unsupported by clinical data.
The lawsuit further alleged Shire marketed Adderall XR based on other unsupported claims, such as the drug would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents and sexually transmitted disease.
Concerning Vyvanes, the lawsuit alleged Shire sale representatives made false statements regarding the "abuseability" of the drug by stating Vyvanes "provides less abuse liability" than "every other long-acting release mechanism" on the market, which was a claim unsupported by any study conducted on the drug. Shire also allegedly claimed Vyvanse would prevent car accidents, divorce, arrests and unemployment.
The lawsuit was filed under the qui tam, or whistle-blower provision, of the False Claims Act by a former Shire executive and a former sales representative.
Although Shire agreed to settle the case, there has been no admission of guilt.
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