SACRAMENTO – California Attorney General Kamala D. Harris and 37 other attorneys general today announced a $68.5 million settlement with AstraZeneca Pharmaceuticals for unfair and deceptive practices in its marketing of the antipsychotic drug Seroquel.
Today’s settlement is the largest multi-state settlement with a pharmaceutical company in history. California will receive more than $5.2 million, the largest share among the states in the consumer protection settlement.
“The health and well-being of patients should drive drug prescriptions in California, not the profits of a pharmaceutical company,” said Attorney General Harris. “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.”
The complaint, filed today with the proposed judgment, alleges that AstraZeneca promoted Seroquel for unapproved uses, failed to adequately disclose potential side effects to health care providers, and withheld scientific studies that called into question the drug’s safety and efficacy.
Seroquel is an antipsychotic medication used to treat schizophrenia and bipolar disorder. It was approved by the Food and Drug Administration (FDA) for treatment of these conditions in adults, but AstraZeneca promoted the drug for children and the elderly to treat a variety of medical conditions, including anxiety, depression, post traumatic stress disorder, Alzheimer’s disease and dementia.
Doctors may prescribe medications for unapproved or “off-label” uses, but drug makers are prohibited from promoting drugs for treatment of medical conditions not approved by the FDA.
A three-year investigation, led by the attorneys general of Florida and Illinois, revealed that AstraZeneca also failed to adequately disclose side effects associated with Seroquel, including weight gain, hyperglycemia, diabetes and cardiovascular complications.
As part of today’s settlement, AstraZeneca agreed to not promote Seroquel in a false, misleading or deceptive manner, including for “off-label” uses. AstraZeneca is required to provide accurate and scientifically balanced responses to requests about off-label usage. The drug maker is also required to enact policies to ensure financial incentives are not given to salespeople for off-label marketing and post payments made to physicians on a website.
States joining California and the District of Columbia in today’s settlement include Arizona, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.
Copies of the related documents are attached to the online version of this release at ag.ca.gov.