AGs settle with Janssen for $181M

WASHINGTON (Legal Newsline) - A $181 million multistate agreement was announced by a group of attorneys general on Thursday with Janssen Pharmaceuticals Inc.

It resolves allegations of deceptive and unfair trade practices in marketing antipsychotic drugs for off-label uses.

"This landmark settlement holds Janssen accountable for its actions and sends a message to all pharmaceutical companies that these practices will not be tolerated," Florida Attorney General Pam Bondi said.

Janssen allegedly marketed the drugs Invega, Risperdal M-Tab, Risperdal Consta and Risperdal using deceptive tactics. Federal law prohibits manufacturers of pharmaceuticals from promoting their products for off-label uses, although physicians may prescribe the drugs for the off-label uses. The company allegedly promoted Risperdal to physicians for use in anxiety, depression, dementia and Alzheimer's disease. The drugs are not FDA-approved for those uses.

Under the terms of the settlement, Janssen will change how it markets and promotes atypical antipsychotics and will refrain from deceptive, misleading or false drug promotions. For a five year period, the company will clearly and conspicuously disclose in promotional materials the specific risks identified in the black-box warning on its product labels, present information about risk and effectiveness in a balanced manner in its promotional materials and refrain from promoting its drugs using selected symptoms of the FDA-approved diagnoses unless particular disclosures are made about the approved diagnoses.

In addition, Janssen will require its scientifically trained personnel, not its sales and marketing personnel, to develop the medical content of scientific communications for address requests for information from health care providers connected to its atypical antipsychotics, refrain from providing samples of its atypical antipsychotics to health care providers who have clinical practices inconsistent with the FDA-approved labeling for the drugs, refrain from using grants to promote the drugs, refrain from using condition medical education funding on its approval of speakers or program content, contractually require medical education providers to disclose the company's financial support of their programs and any financial relationship with speakers and faculty, and put policies in place to make sure that financial incentives are not given to sales and marketing personnel to reward or encourage off-label marketing.

The agreement, which is the largest multistate consumer protection settlement between state attorneys general and a pharmaceutical company, involved 37 attorneys general, including those from the District of Columbia, Wyoming, Wisconsin, Washington, Vermont, Texas, Tennessee, South Dakota, Rhode Island, Pennsylvania, Oregon, Oklahoma, Ohio, North Dakota, North Carolina, New York, New Jersey, New Hampshire, Nevada, Nebraska, Missouri, Minnesota, Michigan, Maryland, Maine, Kansas, Iowa, Indiana, Illinois, Idaho, Hawaii, Delaware, Connecticut, Colorado, Arizona and Alabama.