Pharmaceutical Giant, AstraZeneca LP and AstraZeneca Pharmaceuticals LP has been fined $520 million by the Food and Drug Administration for marketing the anti-psychotic , Seroquel, for uses not approved by the FDA, according a U.S. Department of Health and Human Services announcement.
The off-label uses include promoting Seroquel to psychiatrists and doctors to treat aggression, Alzheimer’s disease, post-traumatic stress disorder, mood disorder, and sleeplessness, among other uses. Consumers and Jacksonville product liability attorneys are concerned that these are not conditions included in the drug’s product label because they are not approved by the FDA. As such, they are not areas that are supposed to be covered by Medicaid, Medicare and TRICARE programs as well as the Department of Veterans Affairs, Bureau of Prisons and Federal Employee Health Benefits program, according to Health and Human Services.
AstraZeneca is accused of targeting doctors who typically do not treat bipolar disorder or schizophrenia. Instead, doctors convinced to use the drug were treating the elderly in nursing homes and treating children and adolescents.
The company is accused of promoting the unapproved uses in company-sponsored medical education programs. It also encouraged doctors by paying them to speak to other medical experts promoting the drug’s use and recruited doctors to author articles actually ghostwritten by AstraZeneca writers. The articles were then used to promote Seroquel, a violation of the federal Anti-Kickback Statute, according to the Department of Justice. The federal investigation was initiated by a whistleblower lawsuit. Because it is a federal action, the whistleblower shares in the recovery, in this instance $45 million.
