April 4, 2019

Pharmaceutical company Lundbeck LLC will pay $52.6 million to resolve allegations that the company violated the False Claims Act by providing funds to a purportedly independent patient assistance program for its drug Xenazine, approved for Huntington’s Disease, in a form that created an improper kickback. Lundbeck was the sole donor to a fund at a foundation that claimed to provide financial support for patients with Huntington’s Disease. However, Lundbeck also referred Xenazine patients with many other conditions to this foundation, which then paid the Xenazine copays for these off-label uses.  When the foundation determined to stop using its Huntington’s fund for non-Huntington’s patient, Lundbeck redirected its payments to a different general-purpose fund, with the understanding that fund would use the redirected funds to pay Xenazine copays for these same patients.  Lundbeck is alleged to have denied needy Medicare and ChampVA Xenazine patients access to its free drug program, instead referring them to the patient assistance program, permitting Lundbeck to submit claims to federal healthcare programs.   DOJ

Tagged in: Anti-Kickback and Stark, Drug and DME Pricing, FCA Federal, Off-Label and Unapproved Use, Pharma Fraud,