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$56.5M Shire Pharma Scam Exposed
Pharmaceutical giant Shire Pharmaceuticals LLC has agreed to pay $56.5 million to settle civil allegations that it defrauded the US government through its false marketing and promotion practices, the Grimy Times has learned. The scandal rocked the nation, highlighting the dark underbelly of the pharmaceutical industry.
According to sources, Shire Pharmaceuticals LLC, based in Wayne, Pennsylvania, manufactured and sold several prescription medications, 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 investigation, led by Acting Assistant Attorney General Joyce R. Branda for the Civil Division, revealed that Shire Pharmaceuticals LLC promoted Adderall XR for certain uses despite a lack of clinical data to support such claims and overstated its efficacy, particularly relative to other ADHD drugs. This included claims that Adderall XR could “normalize” its recipients, rendering them indistinguishable from their non-ADHD peers.
Additionally, Shire Pharmaceuticals LLC allegedly made unsupported claims that Adderall XR would prevent poor academic performance, loss of employment, criminal behavior, traffic accidents, and sexually transmitted disease. The company also promoted Adderall XR for the treatment of conduct disorder without approval from the Food and Drug Administration (FDA).
The settlement further resolves allegations that Shire Pharmaceuticals LLC sales representatives and other agents made false and misleading statements about the efficacy and “abuseability” of Vyvanse to state Medicaid formulary committees and to individual physicians. Shire Pharmaceuticals LLC also allegedly made unsupported claims that treatment with Vyvanse would prevent car accidents, divorce, arrests, and unemployment.
Furthermore, the settlement resolves allegations that Shire Pharmaceuticals LLC representatives improperly marketed Daytrana as less abuseable than traditional, pill-based medications and made phone calls and drafted letters to state Medicaid authorities to assist physicians with the prior authorization process for prescriptions to induce these physicians to prescribe Daytrana and Vyvanse.
“Marketing efforts that influence a doctor’s independent judgment can undermine the doctor-patient relationship and short-change the patient,” said U.S. Attorney Zane David Memeger for the Eastern District of Pennsylvania. The U.S. Attorney’s office will continue to investigate and prosecute pharmaceutical companies that engage in such practices.
Key Facts
- State: Pennsylvania
- Category: Drug Trafficking|Fraud & Financial Crimes|White Collar Crime
- Source: DOJ Press Release ↗
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