The federal government has reached a $520 million settlement with pharmaceutical manufacturer AstraZeneca. The case dealt with the company’s promotion of off-label uses for the antipsychotic drug Seroquel. AstraZeneca promoted Seroquel for uses that are not approved by federal drug regulators, including insomnia and psychiatric conditions besides schizophrenia and bipolar disorder.
U.S. Attorney Michael Levy of Philadelphia, where the settlement was approved, stated that the company had “turned patients into guinea pigs in an unsupervised drug test.” Partly because of all 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. As we have reported, the FDA approves drugs for specific uses, but doctors are free to prescribe as they see fit.
Drug companies are supposed to market medications only for uses that the FDA has approved. But the companies can find lots of ways to get around the restriction. For example, doctors are told about research indicating that a given drug shows promise to treat a condition that the FDA hasn’t yet cleared it for. Since doctors are eager to get the latest treatments for their patients, especially if other physicians are also prescribing the medication, this ploy seems to work. It’s rather ironic that while the federal government works hard to bring drug manufacturers to justice, the Alabama Supreme Court works hard finding ways to protect them. Maybe one of these days – for the good of Alabamians – that will change.
Source: Associated Press
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