The Washington State Attorney General’s office announced that he and 36 other Attorneys General reached a record $181 million dollar settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. Attorney General Rob McKenna and his colleagues allege that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.

The complaint alleges that Janssen engaged in unfair and deceptive practices when it promoted the antipsychotic drugs for unapproved or off-label uses.

After a four year investigation, Janssen agreed to change how it promotes and markets these kinds of drugs.  The settlement also restricts Janssen from promoting the drugs for “off-label” uses – those not approved by the U.S. Food and Drug Administration (FDA).  Additionally, for a five-year period, Janssen:

Must clearly and conspicuously disclose, in promotional materials for atypical antipsychotic products, the specific risks identified in the “black-box” warning on its product labels;

Must present information about effectiveness and risk in a balanced manner in its promotional materials;Shall not promote its atypical antipsychotics using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;Shall require its scientifically trained personnel, rather that its sales and marketing personnel, to develop the medical content of scientific communications to address requests for information from health care providers regarding Janssen’s atypical antipsychotics;

Must refrain from  providing samples of its atypical antipsychotics to health care providers whose clinical practices are inconsistent with the FDA-approved labeling of those atypical antipsychotics; Must not use grants to promote its atypical antipsychotics nor condition medical education funding on Janssen’s approval of speakers or program content;

Must contractually require medical education providers to disclose Janssen’s financial support of their programs and any financial relationship with faculty and speakers; and

Must have policies in place to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing.

Federal Law prohibits pharmaceutical manufacturers from promoting their products for off-label uses; although physicians may prescribe drugs for those uses. The complaint alleges that Janssen promoted Risperdal for off-label uses to both geriatric and pediatric populations, targeting patients with Alzheimer’s disease, dementia, depression, and anxiety, when these uses were not FDA-approved and for which Janssen had not established that Risperdal was safe and effective.

The Attorneys General of the following states and the District of Columbia participated in the settlement: Arizona, California, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, 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, Wisconsin and Wyoming.