Life Sciences

FDA warns AstraZeneca for alleged off-label promotion

Pharma Compliance Alert, December 10, 2008

An AstraZeneca sales representative allegedly promoted the company’s antipsychotic Seroquel and Seroquel XL for an off-label use during an unsolicited sales call with a physician, according to an FDA warning letter.

According to the FDA, the sales representative promoted the drugs to treat major depressive disorder, which is not an FDA-approved use. When the physician requested written information supporting this claim, the company allegedly mailed the physician a list of eight clinical trials supporting the off-label use.

The FDA said the oral statements made by the sales representative and the information provided in the mailing suggests a new intended use for Seroquel and Seroquel XL for which the products lack adequate directions. AstraZeneca’s disclaimer in the physician letter that it does not recommend the off-label use is not sufficient to mitigate the off-label promotion, according to the FDA.


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