Attorney General John Suthers announced today that Colorado will receive $1.4 million as part of a settlement with AstraZeneca Pharmaceuticals to settle allegations that the drug manufacturer engaged in deceptive trade practices while promoting the drug Seroquel.According to the settlement, the UK-based company marketed the atypical psychotic medication Seroquel for off-label uses that had not been approved by the Food and Drug Administration, including the treatment of Alzheimer’s Disease, anxiety, dementia, depression, sleep disorders and post traumatic stress disorder. It generally is not illegal for doctors to prescribe drugs for off-label uses, but it is illegal for drug manufacturers to market drugs for non-FDA-approved uses.
As part of the settlement, AstraZeneca will be required to:
Publicly post on the Internet its payments to physicians;
Have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing;
Implement policies to ensure that the company’s sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use; and,
Cite to Seroquel’s FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel by highlighting symptoms only.
Atypical antipsychotics, including Seroquel, can produce dangerous side effects, including weight gain, hyperglycemia, diabetes, cardiovascular complications, an increased risk of mortality in elderly patients with dementia and other serious conditions.
Colorado was one of 38 states participating in the $68.5 million settlement.
This settlement follows a September 2010 multistate settlement the Office of the Attorney General joined to settle allegations that AstraZeneca’s off-label marketing of Seroquel defrauded the state’s Medicaid program. Colorado received $2 million under that settlement.
Attachments:
Seroquel consumer settlement release
No comments:
Post a Comment