The drug Seroquel has been under scrutiny along with its marketer, the pharmaceutical giant AstraZeneca. The pharmaceutical company is the fourth in the past 3 years to admit to charges of illegal marketing of an antipsychotic. These types of medications are some of the top sellers in the United States, coming in annually with more sales than cholesterol lowering drugs. Considering that Seroquel is generally prescribed for a twice daily dosage at an average of $4 per pill, AstraZeneca certainly made plenty of money on this antipsychotic.
The makers of Seroquel have used aggressive sales strategies and promotional practices to increase the sales of these antipsychotics to children and the elderly. This is not how the FDA approved Seroquel to be used.
The New York Times reported on its website on Monday that at this time AstraZeneca has agreed to sign a corporate integrity agreement over its marketing of Seroquel for unapproved uses. The drug maker will not face criminal charges. AstraZeneca is also paying out $520 million as part of this settlement deal. This settlement brings closure to two federal investigations. One involves doctors who participated in clinical trials, and the other involving the sales organization of AstraZeneca. The investigations centered on the company allegedly misleading doctors and patients about the safety of the drug Seroquel. Throughout the investigation AstraZeneca had repeatedly denied any wrong doing in either case.
The settlement between AstraZeneca and the Federal government does not include the more than 25,000 civil lawsuits that are pending against the corporation claiming that AstraZeneca did not disclose the risks involved with Seroquel. The risks include the possibility of diabetes, and weight gain. None of the promotional materials for Seroquel include this information, and in fact advise using the drug for uses such as elderly dementia, for which it was not approved. These promotional materials as well as reports from patients and lawsuits are what got the FDA involved in investigating the marketing of Seroquel.
This settlement places AstraZeneca in the elite company of Pfizer, Eli Lilly and Bristol-Myers Squibb as pharmaceutical companies who have all been investigated concerning antipsychotic drugs. AstraZeneca is a British company with American headquarters in Wilmington Delaware. To date the company has paid out around $656 million to defend against the civil lawsuits brought on behalf of patients. Yet the settlement leaves AstraZeneca to handle settlement of remaining cases on top of their settlement amount to the government.