AG Gansler Secures $181 Million Settlement with Pharmaceutical Firm
Promotion of drug for off-label use leads to largest-ever settlement of its kind
Baltimore, MD ( Aug. 30, 2012) - Attorney General Douglas F. Gansler announced today that he, joined by 36 other Attorneys General, reached a record $181 million dollar settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson, over its deceptive marketing of the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega. It represents the largest multi-state consumer protection settlement with a pharmaceutical company.
"Placing children and seniors at greater health risk for the sake of boosting profits is deplorable," said Attorney General Gansler. "This settlement is part of our ongoing efforts to ensure that pharmaceutical companies cease any deceptive marketing of prescription drugs."
The complaint filed today by the Attorney General's Consumer Protection Division alleges that Janssen engaged in unfair and deceptive trade 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. These uses were not FDA-approved and Janssen failed to provide the FDA with information establishing that Risperdal was safe and effective for those uses. Additionally, the complaint alleges that Janssen minimized risks associated with Risperdal and made comparisons to competitors' drugs without adequate substantiation.
After an extensive four-year investigation, Janssen 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. In addition to the record-setting payment, the settlement targets specific concerns identified in the investigation. The settlement agreement restricts Janssen from promoting its atypical antipsychotic drugs for off-label uses that the FDA has not approved. Additionally, the settlement agreement requires that Janssen, for the next five years:
- 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;
- 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 employees, 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 neither 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 11-member Executive Committee, which included Maryland, investigated the case and negotiated the settlement. The Attorneys General of the following states and the District of Columbia participated in the settlement: Alabama, Arizona, Colorado, Connecticut, Delaware, Florida, 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.