Irish drug maker Shire PLC pushed attention deficit hyperactivity disorder (ADHD) drugs for un-approved uses and collected federal Medicare reimbursement for these illegal actions, according to a lawsuit filed by the Louisiana attorney general.
The lawsuit alleges that Shire promoted the ADHD drugs Adderall, Adderall XR and Vyvanse for uses that were not approved by the Food and Drug Administration (FDA) such as to treat depression and schizophrenia, and to aid in weight loss.
Doctors have the discretion to write prescriptions for drugs for so-called off-label uses but pharmaceutical companies cannot market drugs for uses not approved by the FDA.
The case was removed to federal court after the drug maker argued the lawsuit belonged there because it involves federal issues such as violations of the Federal Food, Drug and Cosmetic Act, as well as allegations that the company made false claims to Medicaid for ADHD prescriptions for uses that were not approved by the FDA.
Shire also faces a litany of other lawsuits, including allegedly keeping generic versions of the widely prescribed Adderall XR off the market. Consumer lawsuits claim Shrine manipulated the ADHD drug market and kept generic competitors at bay for three years.
Source: Law 360