The pharmaceutical giant has agreed not to promote Seroquel for “off-label” uses which have not been approved by the FDA.
Delaware’s Attorney General Beau Biden and 37 of his colleagues in other states accused AstraZeneca of improperly marketing the anti-psychotic drug for use in ways that were not approved by the U.S. Food and Drug Administration. The states alleged that the company “engaged in unfair and deceptive practices” and “failed to adequately disclose the drug’s potential side effects to health care providers.”
To settle the claims, AZ will pay the largest consumer protection settlement involving a pharmaceutical company in U.S. history. $68.5 million will go to 38 states. Delaware’s share is $1.4 million. That money will go to the state’s Consumer Protection Fund. The company has also agreed to take several steps to improve its adherence with the law. Those steps include publicly posting its payments to doctors on a website, and creating policies to make sure that AZ sales personnel don’t market to health care providers who are unlikely to prescribe Seroquel for an FDA-approved use.
While it is not illegal for doctors to prescribe drugs for off-label use, drug companies are not allowed to market their products for such use. AstraZeneca was accused of touting Seroquel for use in pediatric and geriatric populations, as well as for treatment of anxiety, depression, sleep disorders, and post traumatic stress disorder.