Shire PLC has agreed to pay $56.5 million to settle False Claims Act claims arising out of the improper marketing and promotion of five drugs intended to treat both attention deficit hyperactive disorder (ADHD) and ulcerative colitis. The settlement with the U.S. Department of Justice resolves claims raised in two FCA suits filed in Pennsylvania and Illinois that the company had made claims to prescribers about the uses and benefits of its drugs without proper supporting data. Shire was accused of claiming that its ADHD medication Adderall XR would help to prevent certain issues linked to the condition including poor academic performance, criminal behavior, traffic accidents and sexually transmitted disease. U.S. Attorney for the Eastern District of Pennsylvania Zane Memeger said:
Marketing efforts that influence a doctor’s independent judgment can undermine the doctor-patient relationship and shortchange the patient. Where children’s medication is concerned, it can interfere with a parent’s right to clear information regarding the risks to the safety and health of their child. Shire cooperated throughout this investigation and, in advance of this settlement, began to correct its marketing activities.
The first of the two whistleblower suits was filed in the Eastern District of Pennsylvania in 2008 on behalf of former Shire executive Gerardo Torres. The second was filed in the Northern District of Illinois in 2009 on behalf of three former Shire sales representatives. The suits claimed that the pharmaceutical giant’s boasts about Adderall — as well as the medications Vyvanse and Daytrana — caused false claims seeking payment for the drugs to be submitted to government programs including Medicare and Medicaid. Shire was also accused of claiming without supporting data that patients would be less likely to abuse Vyvanse and Daytrana than Adderall.
In addition, the company was accused of promoting ulcerative colitis medications Lialda and Pentasa for uses not approved by the U.S. Food & Drug Administration (FDA). Lialda was promoted for the prevention for colorectal cancer. Pentasa, meanwhile, was marketed without FDA approval as a treatment for indeterminate colitis and Crohn’s disease.
In addition to providing compensation to the government and paying windfalls to the relators, officials said that Shire had agreed to work with the U.S. Department of Health & Human Services to put new controls in place to oversee marketing and promotional practices. Companies can’t be allowed to profit using false and misleading claims about their products. That is especially true when it comes to drugs and medicines and is even more compelling when drugs marketed for children are involved.
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