By Ed Silverman // March 10th, 2011 // 2:37 pm
AstraZeneca agreed to pay $68.5 million to 36 states and the District of Columbia to resolve a lawsuit charging the drugmaker with illegal marketing of its Seroquel antipsychotic, failing to sufficiently disclose potential side effects to health care providers and withholding negative info in studies about safety and effectiveness.
The drugmaker allegedly marketed Seroquel, which was approved only for schizophrenia and bipolar disorder, for several off-label uses to treat both children and the elderly, specifically in nursing homes. Among the unapproved uses: Alzheimer’s Disease, dementia, anxiety, depression, sleep disorders and post traumatic stress disorder, according to the lawsuit (read here).
“This case sends a message that we take seriously the duty pharmaceutical companies have to supply clear, accurate and complete information about their products to health care providers, and to market their products without deception or misleading claims,” says New Jersey Attorney General Paula Dow, who announced the settlement, in a statement.
“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” an AstraZeneca spokesman writes us.
The agreement does not include lawsuits brought in seven other states and is also separate from a settlement reached nearly a year ago with the US Department of Justice, in which the drugmaker agreed to pay $520 million to resolve charges that it improperly marketed the pill for unapproved uses (back story).
As part of the settlement, AstraZeneca must also publicly post its payments to physicians on a Web site; have policies in place to ensure that financial incentives are not given to marketing and sales personnel for off-label marketing; have policies in place to ensure that AstraZeneca sales personnel do not promote to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use, and cite Seroquel’s FDA-approved indications when referencing selected symptoms, rather than promoting Seroquel by highlighting symptoms only, according to Dow (read the judgment here).