|August 30, 2012
Media Contact: John Lucas
Phone: (850) 245-0150
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TALLAHASSEE, Fla. –Attorney General Pam Bondi announced today that she and 36 other attorneys general have reached a record settlement totaling more than $181 million with Janssen Pharmaceuticals, Inc. This settlement, which follows an investigation and settlement negotiations led by Florida, is the largest multistate consumer protection settlement between state attorneys general and a pharmaceutical company. The agreement resolves allegations that Janssen used deceptive and unfair trade practices to market antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for off-label uses. Federal Law prohibits pharmaceutical manufacturers from promoting their products for off-label uses, although physicians may prescribe drugs for those uses. As a result of the settlement, Florida will receive more than $11 million which will go to future enforcement and reimbursement in attorneys’ fees and costs.
“This landmark settlement holds Janssen accountable for its actions and sends a message to all pharmaceutical companies that these practices will not be tolerated,” stated Attorney General Pam Bondi.
The complaint filed with today’s settlement alleges that Janssen promoted Risperdal for off-label uses to physicians who treated patients with Alzheimer’s disease, dementia, depression, and anxiety. These uses were not FDA-approved.
In 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. Additionally, for a five-year period, Janssen has agreed to additional safeguards including:
- · 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.
Florida was joined in the settlement by the following states: Alabama, Arizona, Colorado, Connecticut, Delaware, 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, Wyoming, and the District of Columbia.
A copy of the complaint can be found here: http://myfloridalegal.com/webfiles.nsf/WF/MMFD-8XNKCH/$file/8.29.12JanssenComplaint.pdf