FDA objects to AstraZeneca sales rep touting off-label Seroquel
This article was originally published in Scrip
In a letter toAstraZeneca, the USFDA's division of drug marketing, advertising and communication stated that it has become aware of an incident whereby a sales rep from the company suggested an unapproved use for Seroquel (quetiapine fumarate).
In the letter, the agency claimed that the sales rep told a doctor in January 2008 that Seroquel was approved for treating major depressive disorder. The doctor then requested information to support the claim, and AstraZeneca sent a mailing that included summaries of eight clinical studies of Seroquel in MDD.
The agency wrote: "This mailing was not the result of an unsolicited request by the physician, but rather was prompted by the sales representative’s statements … because prescribing information for Seroquel and Seroquel XR lack adequate directions for this use, the drugs are therefore misbranded."
According to the FDA letter, AstraZeneca’s mailing said the company did not recommend Seroquel for uses in any other manner than as described in the enclosed prescribing information. But the agency said the disclaimer was "insufficient to mitigate the promotion" of a new use. The agency asked the company to halt using any similar promotional material.