Missouri Attorney General Chris Koster and 37 other attorneys general late last week reached a $181 million settlement with Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson.
Missouri will receive more than $4.3 million as part of the settlement, which resolves allegations that Janssen Pharmaceuticals engaged in unfair and deceptive practices with its marketing of Risperdal, a drug known as an atypical or second-generation antipsychotic, according to a news release.
“Our health system does not work properly when drug manufacturers knowingly conceal the ineffectiveness or risks of drugs,” Koster said in the release. “My office will continue to hold pharmaceutical companies accountable for misleading consumers. We will make them change their unlawful business practices when we discover they have cut corners or cheated the system.”
The settlement ends a four-year investigation that alleged Janssen Pharmaceuticals marketed Risperdal for uses the Food and Drug Administration had denied. Koster said the company sought to boost off-label sales for the drug to treat children, despite knowledge the drug increased the occurence of side effects such as weight gain and movement disorders. According to the release, Janssen Pharmaceuticals also allegedly marketed the drug for elderly dementia patients, though the FDA denied a dementia indication because a company-sponsored study found Risperdal caused a higher risk of death than for those patients taking the placebo.
Koster said the settlement also resolves allegations that Janssen Pharmaceuticals conducted several studies for off-label uses of the drug and promoted the positive results of the studies but not the negative findings.
In addition to settlement payments, Janssen Pharmaceuticals has been restricted from promoting its atypical antipsychotic drugs for off-label uses not approved by the FDA. During the next five years, Janssen also must:
- clearly disclose the specific risks and effectiveness of its drugs in promotions;
- require its scientifically trained personnel, rather than sales and marketing staff, to develop the medical content of scientific communications to health care providers regarding atypical antipsychotics;
- not provide samples of its atypical antipsychotics to health care providers that don't practice in the FDA-approved uses of the drugs;
- disclose its financial support of its programs and financial relationships with faculty and speakers; and
- implement polices to make sure financial incentives aren't given to marketing and sales personnel for promoting off-label uses.
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