Biden Announces Landmark Settlement with Janssen Pharmaceuticals
Record setting payment includes $4.2 million to fund Delaware Consumer Protection Efforts
Wilmington – In the largest multi-state consumer protection settlement with a pharmaceutical company, Attorney General Beau Biden announced today that he and 35 other Attorneys General have reached a record $181 million dollar settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson. The Attorneys General allege that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.
“Marketing drugs for uses that are not FDA approved is an unacceptable threat to the health and wellbeing of Delawareans,” Biden said. “The changes we have secured to this company’s marketing practices, along with the significant financial impact, will help protect the public.”
Today’s settlement was reached in connection with a civil lawsuit Biden’s office filed today in New Castle County Superior Court. The suit, filed after an extensive four-year investigation led by the State of Florida, alleges that Janssen engaged in unfair and deceptive practices when it marketed Risperdal for unapproved or off-label uses. Although physicians may prescribe drugs for off-label uses, federal law prohibits pharmaceutical manufacturers from promoting their products for these purposes. The states’ suit alleges that Janssen promoted Risperdal, among a class of drugs known as atypical or second-generation antipsychotics, 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.
Under the terms of the settlement reached today, Janssen will pay $4.2 million to the Delaware Attorney General’s Consumer Protection Fund. It is also required to change how it promotes and markets its atypical antipsychotics and refrain from false, misleading or deceptive promotion of the drugs. In addition to the record setting payment, the settlement restricts Janssen from promoting its atypical antipsychotic drugs for “off-label” uses not approved by the U.S. Food and Drug Administration (“FDA”). Additionally, for five years, 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 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.
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