Shire agrees to settle whistle-blower suit for fraudulent marketing for $57.5 million

Shire PLC, the Irish pharmaceutical company which makes ADHD drugs including Adderall XR and Vyvnase, said it has agreed to pay $57.5 million to resolve a federal investigation into the marketing of its drugs for treating attention deficit hyperactivity disorder. Œ

Adderall has been approved by the FDA for treatment of ADHD and also to treat narcolepsy. Although there has been no comment from the government concerning the details of off label marketing, currently, the off-bale (non-approved) uses of Adderall include treatment for depression or helping with weight loss. Adderall is a psychostimulant and is a combination of four amphetamine salts. Sometimes, the drug is prescribed for children who are not doing well in school and is widely used as a “study drug” in colleges and universities. This is because of the reported ability to help individuals focus and concentrate at a much higher rate than normal. It also helps individuals stay awake and has been used by the military to help soldiers concentrate and perform in dangerous situations for longer periods of time. Œ

In September 2009, Shire received a subpoena from the U.S. Department of Health and Human Services and the U.S. Attorney’s Office for the Eastern District of Pennsylvania related to documents concerning the sales of adderall XR, Vyvanse and Daytrana. Jeffrey Newman represents whistleblowers.