Iowa reaches settlement with drug company for improper marketing

Iowa and 36 other attorney generals reached a record $181 million settlement Thursday with Janssen Pharmaceuticals, Inc. after attorneys claimed Janssen improperly marketed anti-psychotic drugs.

Attorney General Tom Miller said this was the largest multi-state consumer protection settlement with a pharmaceutical company.

District Judge Mary Pat Gunderson approved the settlement, through a consent judgment, filed Thursday in Polk County District Court.  In a petition , Miller alleged the subsidiary of Johnson and Johnson 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 anti-psychotics.

Janssen will pay the state $3,357,633, according to the settlement.

“This is a significant settlement that sends an important message to the entire pharmaceutical industry," Miller said in a statement. "We cannot and will not tolerate any company improperly marketing its drugs by overstating or misstating their use, their effectiveness or their safety.”

After an extensive four-year investigation, Janssen agreed to change how it promotes and markets its atypical anti psychotics, and also agreed to refrain from any false, misleading or deceptive promotion of the drugs. In addition to the record setting national payment of $181,047,437, 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 U.S. 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 anti psychotic 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 anti psychotics 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 anti psychotics;
• Must refrain from  providing samples of its atypical anti psychotics to health care providers whose clinical practices are inconsistent with the FDA-approved labeling of those atypical anti psychotics;
• Must not use grants to promote its atypical anti psychotics 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 petition 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.

“If a pharmaceutical company contends that a product is safe and effective for treating anything other than an FDA-approved use, there are clear federal laws and regulations that set forth a process, and these rules protect the public,” Miller said.  “Cutting corners and bending rules can put people at serious risk.”

In addition to Miller, 35 attorneys general of the following states, plus the District of Columbia, participated in the settlement: Alabama, Arizona, Colorado, Connecticut, Delaware, Hawaii, Idaho, Illinois, Indiana, 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.

Florida Attorney General Pam Bondi led the investigation into Janssen's marketing and promotional practices.