AstraZeneca joins the list of drugmakers that have settled with U.S. states over allegations of mismarketing their products. The company agreed to pay $68.5 million to wrap up claims from 37 states and the District of Columbia, which had accused the company of promoting its antipsychotic drug Seroquel for off-label uses such as insomnia and Alzheimer's disease. It's the biggest state settlement with a pharma company on record, Reuters reports.
That doesn't mean AZ has admitted to wrongdoing, however. "We deny the allegations," the drugmaker said in a statement. "AstraZeneca believes that it is important to bring these matters to a close and move forward with our business of providing medicines to patients."
The deal comes after AZ resolved off-label marketing charges levied by the U.S. Justice Department, agreeing to pay $520 million to settle the case; seven states are still suing.
The states' legal complaint alleged that AZ promoted Seroquel, which is approved for use in schizophrenia and bipolar disorder, for uses the FDA hasn't blessed. The suit also claimed the company didn't properly disclose potential side effects and deliberately withheld data that raised questions about Seroquel's safety and effectiveness.
The allegations emerged from a three-year investigation led by the attorneys general of Florida and Illinois, the Los Angeles Times reports. The AGs said they found AstraZeneca had kept to itself information on Seroquel's links to weight gain, hyperglycemia, diabetes and heart trouble.
Under the latest settlement, AZ has pledged to avoid off-label or misleading marketing of Seroquel and promised to adopt policies to prevent linking sales reps' financial incentives with marketing Seroquel off-label. Plus, it has to compile a database of payments to doctors and post that information on its website.
Special Report: Big Pharma behaving badly: A timeline of settlements
- check out the Florida AG's release
- read the Reuters news
- see the LA Times piece