Connecticut has joined a $181 million consumer fraud settlement with Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, stemming from allegations the company improperly marketed the antipsychotic drugs Risperdal and Invega.
Connecticut’s share of the settlement is $3.5 million, about $3.1 million of which will be paid into the general fund; the rest will go to the Office of the Attorney General and the Department of Consumer Protection (DCP) consumer funds and the DCP’s prescription-drug monitoring program.
The complaint, brought by 36 states and the District of Columbia, alleged that Janssen’s marketing of Risperdal for unapproved or off-label uses violated the law as an unfair and deceptive practice. Federal law prohibits pharmaceutical manufacturers from promoting their products for off-label uses, although physicians may prescribe drugs for those uses.
The complaint alleged that Janssen promoted Risperdal for off-label use to treat Alzheimer’s disease, dementia, depression and anxiety, even though the U.S. Food and Drug Administration had not approved the drug for these purposes, nor had Janssen shown that Risperdal was safe and effective in treating those conditions.
“The law prohibits off-label marketing for a reason: to protect the health and safety of consumers. This settlement will require this company to follow the law and end the practice of off-label marketing for these drugs,” Attorney General George Jepsen said.
Consumer Protection Commissioner William Rubenstein said the settlement “will presumably send a message throughout the marketplace that promoting medications for off-label use is off-limits for drug companies.”
As part of the settlement, Janssen has agreed to change how it promotes and markets its atypical antipsychotics, and to refrain from any misleading or deceptive promotion of the drugs.
Additionally, for a five-year period, Janssen 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 drugs; require medical education providers to disclose Janssen’s financial support of their programs and any financial relationship with faculty and speakers; and have policies in place to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing.
Last month, a C-HIT investigation found that in Connecticut, about 40 percent of the highest Medicaid prescribers of eight medications, including Risperdal and Invega, received income or benefits from the pharmaceutical companies that manufactured those drugs.
In resolving the allegations by the states, Janssen did not admit wrongdoing or that it violated the law, saying it settled to avoid a prolonged legal battle.
“We have chosen this path to achieve a prompt and full resolution of these state claims and to ensure we continue to focus on our mission of providing medicines to meet the significant unmet needs of many people who suffer from mental illness,” Michael Yang, president of Janssen, said in a statement Thursday.
This story was reported under a partnership with the Connecticut Health I-Team (www.c-hit.org).