List of whistleblowers - Wikipedia. Astra. Zeneca (AZ) whistleblower Jim (James) Wetta filed a False Claims qui- tam case that triggered the United States Department of Justice investigation into Astra. Zeneca violating the Federal Anti- Kickback Statute and promoting the unapproved use of the (anti- psychotic) drug Seroquel.[1. In September 2. 00. Seroquel received FDA approval for the short- term treatment of schizophrenia, then in 2. James Wetta exposed the company's alleged fraud, where sales reps were promoting the drug for a wide range of less serious disorders which included aggression, Alzheimer's disease, anger management, anxiety, attention deficit hyperactivity disorder, bipolar maintenance, dementia, depression, mood disorder, sleeplessness and post- traumatic stress disorder. Promoting drugs off- label amounts to fraud under the False Claims Act, as the unapproved uses were not medically accepted indications for which the federal and state Medicaid programs provided coverage.

Under the Food, Drug and Cosmetics Act, a company must specify the intended use of a product in its new drug application to the FDA. Once the drug is approved by the FDA, the drug may not be marketed or promoted for off- label uses.[1.

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The civil settlement agreement required Astra. Zeneca to pay $5. Jim Wetta provided the information which proved the drug was promoted for conditions other then the FDA medical indication.[1.

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