Johnson & Johnson to pay Vermont $4.1 million as part of landmark settlement
In the largest multi-state consumer protection settlement with a pharmaceutical company ever, Attorney General William H Sorrell announced today that he and 36 other Attorneys General reached a record $181 million settlement with Janssen Pharmaceuticals, Inc, a subsidiary of Johnson & Johnson. Attorney General Sorrell alleges that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.
Filed today, the complaint alleges 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.
“The marketing of drugs for uses for which they are not FDA approved can be extremely harmful to consumers, and this office will continue to aggressively pursue those companies that violate our Consumer Protection Act,” said Attorney General Sorrell. “This settlement will help protect some of Vermont’s most vulnerable citizens, including children, the elderly, and those suffering from mental illness.”
Vermont was on the executive committee of the multi-state group. The committee investigated the matter extensively for over four years. 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 US 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.
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.
This is the fourth multi-state settlement to address off-label marketing of atypical antipsychotics. In March 2011, Vermont settled with AstraZeneca for $1.4 million relating to
off-label marketing of Seroquel; in September 2009, Vermont settled with Pfizer Inc. for $432,000 relating off-label marketing of Geodon; and in October 2009, Vermont settled with Eli Lilly and Company for $1.5 million relating to its off-label marketing of Zyprexa.
Source: Vermont Attorney General, 8.30.2012