Attorney General Michael A. Delaney announced today that after an extensive four-year investigation, he and 35 other Attorneys General have reached a $200 million dollar settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. In a complaint filed today, it is alleged that Janssen engaged in unfair and deceptive practices when it marketed Risperdal for unapproved or off-label uses. Risperdal is among a class of drugs known as atypical or second generation antipsychotics.

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.

Janssen has agreed to change not only how it promotes and markets its atypical antipsychotics but also to refrain from any false, misleading or deceptive promotion of the drugs. In addition to the multi-million dollar payment, the settlement requires Janssen to address specific concerns identified in the investigation. It restricts Janssen from promoting its atypical antipsychotic drugs for "off-label" uses that the U.S. Food and Drug Administration ("FDA") has not approved. 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 than 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.

Attorney General Delaney said "It is extremely important that prescription drugs be used only for the purposes for which they are intended. This multistate settlement calls attention to the dangers that exist when a pharmaceutical company promotes a drug for uses which had not been approved by the FDA and which had not been established to be safe."

New Hampshire's share of the multistate settlement is $2,761,330, which will be used for the protection of New Hampshire consumers, including future consumer protection enforcement, consumer education, or litigation.

The Attorneys General from Florida led the investigation into Janssen's marketing and promotional practices. The Attorneys General of the following states and the District of Columbia participated in the settlement: Arizona, 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.