Largest Multistate Consumer Protection Drug Settlement
Attorney General William J. Schneider announced today that Maine, along with 36 other State Attorneys General, reached a record $181 million dollar settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson.
A complaint and consent decree filed in Kennebec County Superior Court today resolved claims that Janssen violated the Maine Unfair Trade Practices Act when it improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for unapproved or off-label uses. Risperdal is among a class of drugs known as atypical or second generation antipsychotics.
Maine will receive $2.7 million as part of the settlement.
The complaint alleges that Janssen promoted Risperdal for off-label uses to both geriatric and pediatric patients, targeting those with Alzheimer’s disease, dementia, depression and anxiety. Risperdal is approved to treat schizophrenia, bipolar disorder and behavior problems in teenagers and children with autism. While doctors may prescribe medicines as they see fit, companies are allowed to promote them for only uses approved by the U.S. Food and Drug Administration (FDA).
“The sales practices of pharmaceutical companies have increasingly come under scrutiny,” said Attorney General Schneider. “As this lengthy investigation and resulting settlement shows, we are determined to curb illegal marketing that puts patients at risk.”
According to the consent judgment, 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. 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.
This case was handled by Assistant Attorney General Christina Moylan of Attorney General Schneider’s Consumer Protection Division.
The Attorneys General from Florida led the investigation into Janssen’s marketing and promotional practices. The Attorneys General of the following states and the District of Columbia participated in the settlement: Alabama, Arizona, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, 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.
