AstraZeneca has agreed to pay the U.S. government $520 million to settle charges over Seroquel, resolving a federal probe that accused the drug maker of illegally promoting their popular antipsychotic medication for non-approved uses.
The settlement over Seroquel is expected to be announced Wednesday by the U.S. Department of Justice (DOJ), according to a report by the New York Times. AstraZeneca will not admit to wrongdoing in the settlement, and will enter into a corporate integrity agreement with DOJ.
Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Originally approved by the FDA in 1997 for the treatment of schizophrenia, it has been frequently prescribed off-label for uses that were not approved as safe and effective at the time, such as anxiety, obsessive dementia, compulsive disorders and autism.
While doctors are free to prescribe approved medications for non-approved uses, drug makers are barred from promoting or encouraging such “off-label” use. Since it was approved, Seroquel has been used by more than 19 million people worldwide, and some people have estimated that at one time as much as 70% of all seroquel prescriptions were for unapproved uses.
According to internal company documents uncovered through Seroquel litigation, off-label promotion of the drug has been a key marketing strategy for AstraZenca since at least 2000. During pretrial proceedings in lawsuits over Seroquel filed by consumers who developed diabetes and other health problems after using the drugs, company papers were released that had the stated objective to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” even though treatment of bipolar disorders was not approved at the time.
The company first announced it had reached an agreement in principle to settle the Seroquel case with the DOJ in a November filing with the U.S. Security Exchange Commission (SEC).
In addition to the federal probe, AstraZeneca faces an estimated 26,000 Seroquel lawsuits in state and federal courts throughout the United States involving allegations that the drug maker failed to adequately warn about the risk of serious side effects. In November 2009, a federal judge presiding over thousands of cases ordered both sides to meet with a mediator to see if there is any possibility for a settlement of Seroquel injury cases before individual trial dates are scheduled in federal district courts throughout the United States.