State of New Jersey Attorney General Announces Multi-State Settlement with AstraZeneca Over Allegedly Deceptive Marking Practices

TRENTON – Attorney General Paula T. Dow announced today that New Jersey has entered into a $68.5 million, multi-state settlement agreement with pharmaceutical manufacturer AstraZeneca that resolves allegations the company deceptively marketed its anti-psychotic drug Seroquel.

Under the settlement agreement, New Jersey will receive approximately $1.85 million. Thirty-six states and the District of Columbia also are party to the settlement, described as the largest-ever multi-state, consumer-protection-based pharmaceutical settlement.

A Verified Complaint, filed in New Jersey Superior Court today along with a Final Consent Judgment memorializing the settlement, charges that AstraZeneca engaged in unfair and misleading practices when it marketed Seroquel for unapproved or off-label uses. The Complaint also alleges that AstraZeneca failed to adequately disclose the potential side effects of Seroquel to health care providers, and withheld negative information contained in scientific studies regarding the safety and efficacy of Seroquel.

“This is an important settlement for all New Jersey residents,” said Attorney General Dow. “This case sends a message that we take seriously the duty pharmaceutical companies have to supply clear, accurate and complete information about their products to health care providers, and to market their products without deception or misleading claims.”

“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas R. Calcagni, Acting Director of the Division of Consumer Affairs.

“The importance cannot be overstated, when the health and safety of New Jersey residents are at stake,” Calcagni said.

Following a three-year investigation by the participating states, the Delaware-based AstraZeneca agreed not to promote Seroquel in a false, misleading or deceptive manner, including for “off-label” uses, which are not approved by the U.S. Food and Drug Administration. In addition to the overall $68.5 million payment, terms of the settlement include provisions that address specific concerns identified in the states’ investigation. The agreement specifically requires AstraZeneca to:

• Publicly post its payments to physicians on a Web site
• Have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing
• Have policies in place to ensure that AstraZeneca sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use
• Cite to Seroquel’s FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel by highlighting symptoms only

Although a physician is allowed to prescribe drugs for off-label uses, the law prohibits pharmaceutical manufacturers from marketing their products for off-label uses. AstraZeneca allegedly marketed Seroquel for a number of off-label uses, including for use in pediatric and geriatric populations, specifically in nursing homes for Alzheimer’s Disease and dementia, as well as for anxiety, depression, sleep disorders, and post traumatic stress disorder. AstraZeneca promoted Seroquel for such uses even though Seroquel was not, at the time it was marketed, approved for treatment of these conditions, and AstraZeneca had not established that Seroquel was safe and effective for these uses. Atypical anti-psychotics, including Seroquel, can produce dangerous side effects including weight gain, hyperglycemia, diabetes, cardiovascular complications and increased risk of mortality in elderly patients with dementia.

In addition to New Jersey, the following states and the District of Columbia participated in the settlement: Florida, Illinois, Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

Money paid to New Jersey as a result of the AstraZeneca settlement will be used for consumer protection initiatives. Deputy Attorney General Gina M. Betts, assigned to the Division of Law’s Consumer Fraud Prosecution Section, handled the matter on behalf of the State.

via nj.gov

Posted by insider