Pharmaceutical giant AstraZeneca will pay $68.5 million as part of a multistate settlement over allegations that it promoted its psychiatric drug Seroquel for unapproved uses, such as treating insomnia and Alzheimer's disease.
The settlement will be shared by 37 states and the District of Columbia, California Atty. Gen. Kamala D. Harris said Thursday. California will receive more than $5.2 million, which will be used to cover litigation costs and add to the state's consumer protection fund, Harris said.
The drug firm admitted no wrongdoing. "We deny the allegations," it said in a statement. "AstraZeneca believes that it is important to bring these matters to a close and move forward with our business of providing medicines to patients."
The complaint alleged that London-based AstraZeneca promoted Seroquel — which is used to treat schizophrenia and bipolar disorder — for unapproved uses, failed to properly disclose potential side effects and withheld studies that questioned the safety and effectiveness of the drug.
"The health and well-being of patients should drive drug prescriptions in California, not the profits of a pharmaceutical company," Harris said in a statement. "This settlement puts an end to unscrupulous marketing practices and protects consumers from misguided, and potentially dangerous, treatment with Seroquel for uses the FDA has not approved."
Seroquel was approved by the Food and Drug Administration for treatment of schizophrenia and bipolar disorder in adults. AstraZeneca was accused of promoting the drug for use by children and the elderly and for treatment of several unapproved conditions, including anxiety, depression, post traumatic stress disorder, Alzheimer's disease and dementia.
Doctors can prescribe medications for "off-label" uses, but pharmaceutical companies are prohibited from marketing drugs for uses that are not approved by the Food and Drug Administration, Harris said.
A three-year investigation led by the attorneys general of Florida and Illinois found that AstraZeneca also failed to properly disclose possible side effects, including weight gain, hyperglycemia, diabetes and cardiovascular complications.
Under the settlement, AstraZeneca agreed to not market the drug in a misleading manner or for unapproved uses and to provide accurate responses to requests about off-label usage, Harris said. The company must also enact policies to ensure that no financial incentives are given to sales representatives for unapproved marketing, and it must post on a website any payments made to physicians.
Last April the company reached a $520-million settlement with the U.S. government, also over allegations that it marketed Seroquel for off-label uses. California received $31 million of that settlement.