Tennessee will receive approximately $4.5 million as part of the largest ever multistate consumer protection agreement with a pharmaceutical company for alleged deceptive marketing practices.
Attorney General Bob Cooper announced that he and 35 other Attorneys General reached a record $181 million agreement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. The multistate group alleges that Janssen improperly marketed the atypical (second generation) antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab, and Invega.
The States allege that Janssen engaged in unfair and deceptive practices when it marketed Risperdal for unapproved or off-label uses. Specifically, 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.
"My Office is pleased to resolve these allegations," Attorney General Cooper said. "We will continue our efforts to stop deceptive marketing, especially when it could potentially risk the health of Tennesseans. "
After an extensive four-year investigation, Janssen agreed to change how it promotes and markets its atypical antipsychotics and agreed to refrain from any false, misleading or deceptive promotion of the drugs. In addition to the record setting payment, the court-approved agreement targets specific concerns identified in the investigation. The agreement 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 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.
The State's complaint and agreed final judgment may be viewed by going online to www.tn.gov/attorneygeneral and clicking on "Filings of Interest." Consumers may file complaints regarding prescription drug advertisements or any other deceptive conduct by going online to www.tn.gov/consumer or calling the TDCI Division of Consumer Affairs at (615) 741-4737 or toll-free in Tennessee at 1-800-342-8385.