Healthy Skepticism Library item: 19343

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Cronin Fisk M, Feeley J
AstraZeneca to Pay $68.5 Million to U.S. States Over Seroquel Marketing
Bloomberg News 2011 Mar 11
http://www.bloomberg.com/news/2011-03-10/astrazeneca-to-pay-68-5-million-to-states-over-seroquel-marketing-claims.html

Full text:

AstraZeneca Plc (AZN) agreed to pay $68.5 million to 37 U.S. states and the District of Columbia to resolve allegations that the company deceptively marketed its anti-psychotic drug Seroquel.

The settlement, announced today, is separate from a $520 million agreement London-based AstraZeneca reached with the U.S. last year over the marketing of Seroquel, said Tony Jewell, a company spokesman.

“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” Jewell said. The company intends to “vigorously defend ourselves” in remaining lawsuits, he said.

AstraZeneca didn’t admit wrongdoing, and the settlement doesn’t resolve lawsuits brought by about seven states, including South Carolina and Mississippi, Jewell said today in an interview.

The company marketed Seroquel for uses that weren’t approved by the U.S. Food and Drug Administration, the federal and state governments claimed. AstraZeneca promoted the drug, approved for schizophrenia and bipolar disorder, for dementia, depression and anxiety in violation of federal drug rules, according to the states.

While doctors can prescribe medicines for other diseases, companies aren’t allowed to market drugs beyond approved uses.

Side Effects

The states also claimed AstraZeneca failed to adequately disclose Seroquel’s side effects, minimizing the risk of high blood sugar and diabetes.

The office of New Jersey Attorney General Paula Dow announced the settlement.

“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,” Dow said in a statement.

In addition to paying the $68.5 million, AstraZeneca officials agreed to ban financial incentives tied to off-label marketing, instruct salespeople not to market Seroquel to doctors who are unlikely to prescribe it for an approved use, and post payments to doctors on a website, according to the statement.

The settlement provides payments to individual states including $5.2 million to California, $3.8 million to Texas, $3.1 million to New York, $2.6 million to Ohio, $1.85 million to New Jersey and $1.4 million to Colorado, according to attorneys general in those states.

The New Jersey lawsuit is Dow v. AstraZeneca, MER-C-24-11, New Jersey Superior Court, Mercer County (Trenton).