Johnson And Johnson Subsidiary To Pay States $181 Million In Drug Marketing Settlement
Boise, Idaho (KMVT-TV) – Idaho has joined with 37 other states in a $181 million settlement with Janssen Pharmaceuticals, Inc., Attorney General Lawrence Wasden said today. The agreement resolves the states’ claims that Janssen, a subsidiary of Johnson and Johnson, improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.
The states alleged that Janssen engaged in unfair and deceptive practices when it marketed Risperdal for off-label uses, targeting patients with Alzheimer’s disease, dementia, depression, and anxiety. These uses were not FDA-approved and Janssen had not established that Risperdal was safe and effective for these 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.
Under terms of the settlement, Janssen agreed to change how it promotes and markets its atypical antipsychotics and to refrain from any false, misleading, or deceptive promotion of the drugs. The settlement 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.
Idaho will receive $2,847,890 as its share of the settlement. The money will be deposited into the Consumer Protection Account, which partially funds the Attorney General’s consumer protection operations.
In agreeing to the settlement, Janssen Pharmaceuticals admitted no wrongdoing.