AstraZeneca Busted By FDA For Off-Label Marketing Of Seroquel For Depression

News is just out that the FDA has caught AstraZeneca marketing its star atypical antipsychotic Seroquel off-label for depression. Under federal law, drug companies are not allowed to directly market drugs to doctors or to consumers for anything other than FDA approved uses. Seroquel is approved for the treatment of schizophrenia, acute mania in bipolar disorder and bipolar depression.

From the FDA's letter to the company, dated Dec. 1, 2008:

"On Thursday, January 3,2008, at approximately 3:00 p.m., a sales representative from AZ in the [location redacted] made an unsolicited sales call to a physician at his office. The representative stated that Seroquel was approved for treatment of major depressive disorder (MDD). This representation was not made in response to a request for such information by the physician. As a result of this representation, the physician requested that AZ provide written information to support the claim that Seroquel has been approved for the treatment of MDD. In response to this request, AZ sent the physician a mailing dated January 4, 2008.

"The mailng contained information about Seroquel and Seroquel XR's use for MDD, and
included summaries of eight clinical trials with referenced citations. This mailng was not the result of an unsolicited request by the physician, but rather was prompted by the sales representative's statements....

"[T]he oral statements made by the sales representative and the information provided in the January 4, 2008, mailng, misleadingly suggest a new 'intended use' for Seroquel and Seroquel XR. Because the Pis for Seroquel and Seroquel XR lack adequate directions for this use, the drugs are therefore misbranded. Although the letter to the physician states that '(AZ) does not recommend the use of SEROQUEL or SEROQUEL XR in any other manner than as described in the enclosed prescribing information,' this disclaimer is insufficient to mitigate the promotion of a new 'intended use' for which the products lack adequate directions.

Seroquel was not then and is not now approved for use in treating depression. The company has an application currently before the FDA to gain approval of the drug's use in depression, as well as anxiety.

This has to count as one of the more egregious off-label marketing efforts by a pharma company that I've ever seen. The 97 pages of promotional material AstraZeneca sent the doctor can be viewed on the FDA's website (5 MB pdf). I've not had a chance to review the material myself.

The FDA is requesting that AstraZeneca halt distributing such materials and reply to the FDA by Dec. 15 as to whether it intends to comply with the request. I would hope that the FDA would do more than just ask the company to stop marketing the drug off-label, but would take other action as well, since off-label marketing allegations have been swirling around Seroquel and other atypical antipsychotics for several years and here the FDA has caught one of the companies red-handed. The agency ought to step up for the integrity of drug approval and post-approval marketing regulations.

You've got to wonder how many doctors were similarly approached by company sales reps touting the drug's use in depression and, possibly, other disorders where the use would be off-label.

An AstraZeneca spokeswoman tells Pharmalot that the company:

"takes these allegations seriously and we are conducting a full investigation. We have a robust compliance program that calls for responsible sales and marketing practices that comply with applicable laws, regulations and industry standards, as well as AstraZeneca internal policies.

"AstraZeneca has policies and procedures in place that provide direction to its employees about the appropriate promotion of our products and the appropriate handling of requests from physicians for clinical information about our products. Although the allegations related to one isolated incident, AstraZeneca is taking steps to reinforce with the sales force the application of relevant AstraZeneca policies and standards, to continue to reinforce appropriate interactions with physicians."

If the company's compliance program is so robust then how did such materials get sent to a doctor?