BALTIMORE (March 13, 2011) - Attorney General Gansler announced Thursday that his Consumer Protection Division has reached a record $68.5 million dollar settlement with AstraZeneca Pharmaceuticals LP and AstraZeneca LP related to AstraZenecas alleged improper marketing of the antipsychotic drug Seroquel. The settlement is the largest ever multi-state consumer protection-based pharmaceutical settlement. Maryland will receive nearly $2 million dollars as a result of the settlement.
The Consumer Protection Division will be filing a consent decree and complaint in the Circuit Court for Baltimore City against AstraZeneca. The complaint alleges that AstraZeneca engaged in unfair and deceptive trade practices when it marketed Seroquel for off-label uses, which are uses that have not been approved by the U.S. Food and Drug Administration (FDA).
This settlement demonstrates that Maryland is committed to remedying improper marketing by pharmaceutical companies, said Attorney General Gansler.
Seroquel is the brand name for the prescription drug quetiapine fumarate. The complaint alleges that AstraZeneca promoted Seroquel for a number of off-label uses, including for pediatric use, for use in nursing homes for patients with dementia or Alzheimers disease, and for anxiety, depression, and sleep disorders, even though it had not been approved for the treatment of these conditions. Federal law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
The complaint also alleges that AstraZeneca failed to adequately disclose the drugs potential side effects to health care providers and withheld negative information contained in scientific studies concerning the safety and efficacy of Seroquel.
The settlement agreement requires AstraZeneca to:
refrain from making false, misleading or deceptive claims regarding Seroquel;
refrain from promoting Seroquel for off-label uses;
present information about effectiveness and risk in a balanced manner;
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;
report clinical research regarding Seroquel in an accurate, objective and balanced manner; and,
register and post on a publicly accessible website certain AstraZeneca-sponsored clinical studies regarding Seroquel.
In addition, for a six-year period, AstraZeneca must:
refrain from promoting Seroquel using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;
have policies in place to prevent the delivery of samples of Seroquel to health care specialists who are unlikely to prescribe Seroquel for an FDA-approved use;
require its scientifically trained personnel, rather than its sales and marketing personnel, to develop the medical content of all scientific communications to address requests for information regarding Seroquel from health care providers;
require its scientifically trained personnel to be responsible for the identification, selection, approval, and dissemination of scientific article reprints containing off-label information regarding Seroquel, and that such information not be referred to or used in a promotional manner;
disclose on its website information about medical education grants it makes regarding Seroquel, including continuing medical education grants;
refrain from using any grant to promote Seroquel;
contractually require medical education providers to disclose AstraZenecas financial support of their programs and any financial relationship with faculty and speakers.
For a five-year period, AstraZeneca must publicly post on a website the payments it makes to physicians for performing promotional activities.
The Executive Committee states that investigated the case and negotiated this settlement include Maryland, as well as Arizona, Delaware, District of Columbia, Florida, Illinois, Kansas, Massachusetts, North Carolina, Ohio, Pennsylvania, Vermont.
The participating states in the settlement are: Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia, and Wisconsin.
Source: Office of Attorney General Gansler