[Corp. Watch] Big Pharma fined for going "off label" again

[Corporation Watch]

Attorney General: Drugmaker AstraZeneca to Pay $520 Million Fine

By Pete Yost

(Associated Press, April 27) -- The federal government on Tuesday reached a $520 million settlement with pharmaceutical manufacturer AstraZeneca, resolving allegations of illegal marketing of the company's anti-psychotic drug Seroquel.

	At a news conference, Attorney General Eric Holder and Health and Human Services Secretary Kathleen Sebelius made the case a centerpiece of the federal government's crackdown on healthcare fraud.

	AstraZeneca allegedly marketed Seroquel for "off label" uses -- those not approved by federal drug regulators -- including insomnia and psychiatric conditions other than schizophrenia and bipolar disorder.

	U.S. Attorney Michael Levy of Philadelphia, where the settlement was filed, said that the company had "turned patients into guinea pigs in an unsupervised drug test."

	AstraZeneca faces more than 25,000 product liability lawsuits over Seroquel, with most alleging that the drug caused diabetes. Seroquel has been on the market since 1997. The government said AstraZeneca paid kickbacks to recruit doctors as authors of articles by Astra Zeneca and its agents about the unapproved uses of Seroquel.

	The company also made payments to doctors to travel to resort locations to advise AstraZeneca about marketing messages for unapproved uses of the drug, the government stated.

	AstraZeneca denied the allegations leveled by the government in the civil case settled Tuesday, saying it wanted to avoid the delay, uncertainty, and expense of a protracted legal battle.

	"The company is committed to meeting the expectations and obligations of a leading bio-pharmaceutical company, while continuing to provide valuable medicines to millions of patients," Glenn Engelmann, the company's U.S. general counsel, said in a statement.

	Partly because of the off-label use of Seroquel, the drug brought in $4.9 billion to AstraZeneca in 2009, making it the company's second-best seller.

	The Food and Drug Administration (FDA) approves drugs for specific uses, and drug companies are supposed to market medications only for uses that the FDA has approved. Doctors, however, are free to prescribe drugs as they see fit. Such off-label use is a gray area and a long-running controversy when it comes to drug regulation.

	Drug company salespeople can find lots of ways to get around the off-label restrictions. For example, they can let doctors know about research indicating that a given drug shows promise to treat a condition that the FDA hasn't yet cleared it for.

	Doctors are eager to get the latest treatments for their patients, especially if other physicians are also prescribing the medication.