Shire Pharmaceuticals Taking Matters Into Their Own Hands

 

Shire Pharmaceuticals  will pay $56.5 million to settle allegations that it violated the False Claims Act by engaging in unlawful drug marketing and promotion practices of several drugs.  Shire manufacturers and sells pharmaceuticals including Adderall XR, Vyvanse and Daytrana, which are approved for the treatment of attention deficit hyperactivity disorder (ADHD) and Pentasa and Lialda, which are approved for the treatment of mild to moderate active ulcerative colitis. 

The settlement resolves allegations that Shire violated the False Claims Act by making false and unsupported claims related to Adderall XR, Vyvanse and Daytrana and that Shire promoted Pentasa and Lialda for off-label uses not approved by the FDA and not covered by federal healthcare programs. As part of the settlement, Shire entered into a Corporate Integrity Agreement that requires comprehensive compliance safeguards, oversight of Shire promotional activities, and compliance certifications from Shire’s board of directors and  management.