A Johnson & Johnson unit agreed Thursday to pay $181 million to settle dozens of states’ claims that it engaged in illegal off-label marketing of antipsychotic drugs, with New Jersey to receive $5.3 million.
Janssen Pharmaceuticals Inc. of Titusville improperly marketed Risperdal, Risperdal Consta, Risperdal M-Tab and Invega, in violation of federal law, according to Chiesa v. Janssen Pharmaceuticals, MER-C-75-12.
The drugs are primarily used to treat schizophrenia and bipolar mania, but have off-label uses.
While doctors also may prescribe Risperdal to treat Alzheimer’s disease, dementia, depression and other disorders, the Food and Drug Administration has not approved it for those uses, and drug makers can’t promote drugs for secondary uses under the Food, Drug and Cosmetic Act.
After a four-year investigation led by Florida and years of negotiations, Janssen settled. One suit filed by the state Attorney General’s Office on Thursday alleged violations of the state Consumer Fraud Act and resolved the matter in a consent judgment.
Janssen, aside from paying the settlement, also agreed to change its marketing practices.
Among other things, the company is required to:
• Present information about effectiveness and risk in a balanced manner in promotional activities.
• Refrain from compensating health-care professionals merely for attending promotional events.
• Ensure that it is not giving incentives to sales and marketing professionals to engage in improper promotion of Risperdal.
• Ensure that “scientifically trained personnel,” not sales and marketing personnel, develop and approve nonpromotional communications answering unsolicited requests for information about the drug, and disseminate reprints of articles about Risperdal that have appeared in medical journals.
• Require dissemination of articles containing off-label information to be considered by a review committee of professionals from Janssen’s clinical, medical affairs, compliance, law and promotional regulatory departments.
• Include, with article reprints, the FDA-approved labeling for Risperdal and a cover page indicating that the piece discusses off-label use.
• Refrain from using those articles as promotional materials.
• Refrain from using medical education grants to promote Risperdal, including prohibiting sales and marketing personnel from handling a customer’s or doctor’s grant application, or selecting grantees or promotional speakers.
• Contractually require medical education speakers to disclose to promotional event attendees that Janssen is financially supporting the event.
• Provide product samples only to professionals who treat conditions for which the FDA has approved Risperdal to treat, and refer sample requests for off-label use to the company’s medical education department.
Attorney General Jeffrey Chiesa called the settlement “important to protecting New Jersey consumers because it calls for patients and health care providers to have access to clearer and more objective information about the drugs at issue” and “requires that scientifically trained professionals — not people whose expertise is marketing and sales — take the lead in generating that information.”
Janssen President Michael Yang said the company decided to settle “to achieve a prompt and full resolution” of the claims.
Aside from New Jersey, 35 states and the District of Columbia joined in the litigation, filing separate suits. Division of the $181 million settlement among the plaintiff states was determined by an executive committee consisting of 11 of the 37 plaintiffs: Arizona, Delaware, the District of Columbia, Florida, Illinois, Kansas, Maryland, North Carolina, Ohio, Pennsylvania and Vermont.
Awards range from $11.79 million to $2.5 million.
Florida’s was largest, followed by Texas’, at $11.37 million; New York, $9 million; Pennsylvania, $8.44 million; Illinois, $8.31 million; Ohio, $7.87 million; and North Carolina, $7.18 million.
Lee Moore, Chiesa’s spokesman, says New Jersey’s $5.3 million, the 11th-highest award, will go toward consumer-protection and consumer-awareness initiatives.
The agreement notes that the amount is not a fine or penalty.
Joanne Lewers of Drinker Biddle & Reath in Philadelphia, who represented the pharmaceutical companies, defers comment to Janssen.
Deputy Attorney General Lorraine Rak, chief of the Consumer Fraud Prosecution Section, handled the matter. •