Drug Firm to Pay Huge Fine in Illegal Marketing Case

The District of Columbia and the 37 states that sued the pharmaceutical firm AstraZeneca over charges of deceptive marketing practices will divide $68.5 million, according to a settlement to which the company agreed in early March.

The charges involved the company's promotion of the atypical antipsychotic drug Seroquel (quetiapine) for off-label uses, including for treatment of sleep disorders, anxiety, and Alzheimer's disease and other dementias—uses not approved by the Food and Drug Administration (FDA) for Seroquel. Physicians are allowed to prescribe a medication for uses not approved by the FDA, but it is illegal for drug companies to promote the drug for such nonapproved, or off-label, uses.

The FDA has approved Seroquel to treat schizophrenia, as well as both acute manic and depressive episodes in bipolar disorder.

Charges against AstraZeneca also included failure to warn of potential side effects such as weight gain, hyperglycemia, and diabetes and withholding some data relating to the drug's safety and effectiveness.

Despite its agreeing to the settlement, AstraZeneca issued a statement saying that it denied the allegations, but "believes that it is important to bring these matters to a close and move forward with our business of providing medicines to patients."

In addition to the financial payments the company will make to the 38 jurisdictions that were plaintiffs in the lawsuit, it has agreed as part of the settlement to post on a Web site the payments for various professional activities that it makes to physicians and to guarantee that it will not pay any of its marketing representatives for recommending the drug for off-label uses. The company also agreed to refer to the indications for Seroquel's use that have been approved by the FDA when discussing symptoms the drug can treat and to avoid focusing discussions with health care providers on symptoms alone.

Similar lawsuits against AstraZeneca over Seroquel marketing have been filed in seven states in addition to the 37 covered by the March settlement. Those are Alaska, Arkansas, Mississippi, Montana, New Mexico, South Carolina, and Utah.

In April 2010 AstraZeneca agreed to pay the U.S. government and state Medicaid programs $520 million to settle a lawsuit filed against it by the Justice Department based on similar charges regarding the company's promotion of several non-approved uses for Seroquel, including for Alzheimer's, aggressive behaviors, depression, and posttraumatic stress disorder. In agreeing to that settlement, the company also denied the allegations of illegal activities (Psychiatric News, June 18, 2010). It still faces thousands of civil lawsuits filed by individuals who allege serious adverse effects stemming from their use of Seroquel.