Illegal Drug Promotion Costs Company Half-Billion Dollars

AstraZeneca has agreed to pay $520 million to settle a federal civil lawsuit in which the company was accused of illegally promoting its antipsychotic drug quetiapine, marketed under the brand name Seroquel, for unapproved indications.

The April 27 announcement marked the latest case in a string of federal lawsuits filed by the Department of Justice (DoJ) against major drug companies involving off-label drug marketing.

Last fall, Pfizer paid a record $2.3 billion to settle cases involving illegal promotions of four drugs, including ziprasidone (Geodon) and pregabalin (Lyrica) (Psychiatric News, October 2, 2009). Previous cases involving off-label promotions included ones against Eli Lilly for marketing olanzapine (Zyprexa), BristolMyers Squibb for marketing aripiprazole (Abilify), and Cephalon for marketing modafinil (Provigil).

Federal prosecutors alleged that from 2001 through 2006 AstraZeneca promoted quetiapine for treating unapproved conditions, including aggression, agitation, dementia, attention-deficit/hyperactivity disorder, depression, posttraumatic stress disorder, and insomnia.

Last December, the FDA approved quetiapine as an adjunctive treatment for depression but rejected the company's application for its use in depression as a monotherapy.

The lawsuit alleged that the company targeted off-label promotion to primary care physicians, pediatricians, and geriatricians “who do not typically treat schizophrenia or bipolar disorders,” according to the DoJ statement. The company was also accused of influencing continuing medical education programs it sponsored to promote the off-label use of quetiapine.

Quetiapine is one of AstraZeneca's leading products and accounted for more than $4.8 billion in worldwide sales in 2009. However, AstraZeneca recently announced that as part of a corporate restructuring, it plans to eliminate its research and development programs involving medications to treat psychiatric disorders.

In the settlement of the federal suit, AstraZeneca denied any wrongdoing. The company continues to face more than 10,000 civil suits filed by individuals alleging personal injuries, primarily development of diabetes, due to taking quetiapine.