FOR IMMEDIATE RELEASE : Thursday, August 30, 2012
CONTACT: Sara Rabern, (605) 773-3215
Attorney General Jackley and 35 Attorneys General Reach Multimillion Dollar Settlement with Janssen Pharmaceuticals, Inc., a Subsidiary of Johnson & Johnson
PIERRE, S.D.- Attorney General Marty Jackley announced today that he and 35 other Attorneys General, reached a record $200 million dollar settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. The States 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 marketed Risperdal for unapproved or off-label uses for treatment of a variety of conditions including, but not limited to depression, anxiety, sleep disorders and in the geriatric population for the treatment of dementia. South Dakota’s share in this settlement is $2,588,188.
“The marketing of drugs for off-label use seriously endangers consumers,” said Jackley. “This settlement serves notice that practices like these will not be tolerated and do have consequences.”
Janssen has agreed to change not only how it promotes and markets its atypical antipsychotics but also agreed to refrain from any false, misleading or deceptive promotion of the drugs. The settlement agreement also 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.
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.