WILMINGTON, Del. (Legal Newsline) - Thirty-eight state attorneys general announced a record-breaking $68.5 million agreement with a drug company Thursday over allegations of improper marketing practices.
The multistate agreement arose from a federal court complaint against AstraZeneca over its alleged unlawful marketing of the antipsychotic drug Seroquel for unapproved or off-label uses.
AstraZenecda was also charged with failing to disclose harmful weight gain-related side effects of Seroquel and concealing scientific data that revealed safety concerns.
"AstraZeneca promoted Serqouel to treat children and seniors even though federal regulators deemed it an inappropriate use of the potent drug. The company's illegal practices put our most vulnerable populations at risk, including children and older patients with dementia and other debilitating diseases," Illinois Attorney General Lisa Madigan said.
"This settlement is part of a commitment by my office to protect patients by banning this type of irresponsible marketing."
Under terms of the settlement, AstraZeneca will comply with state and federal laws governing the marketing of its products, including legal requirements prohibiting manufacturers from promoting products for off-label uses that are not approved by the U.S. Food and Drug Administration.
Physicians may prescribe drugs for off-label uses, but pharmaceutical manufacturers are not allowed to market products for such use until approved by the FDA.
AstraZeneca allegedly marketed Seroquel for numerous off-label purposes, targeting Alzheimer's patients at nursing homes, and patients suffering from anxiety, depression, sleep disorders and post traumatic stress syndrome.
Injunctive provisions in the settlement require AstraZeneca to publish any payments it makes to physicians on the internet, implement policies that ensure its marketing and sales personnel are not financially compensated for marketing off-label uses, and establish policies to ensure that its sales personnel refrain from marketing Seroquel to healthcare prodivers who are unlikely to prescribe it for and FDA-approved used.
Additionally, injunctive provisions in the settlement require AstraZeneca to cite Seroquel's FDA-approved indicators when referencing selected symptoms.
The settlement tops a similar $62 million Eli Lilly settlement from 2008 that resolved allegations about the drug Zyprexa, a different antipsychotic drug that was also allegedly marketed for off-label uses.
Madigan and Florida Attorney General Pam Bondi took a lead role in the settlement, Madigan says.
Also joining the settlement were attorneys general from Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Hawaii, Idaho, 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.