“This settlement will ensure that Janssen promotes drugs only for those conditions approved by the FDA,” said Attorney General Horne. “It provides safeguards to prevent improper marketing to elderly people with dementia and children and adolescents who don’t suffer from the relatively rare psychiatric conditions for which Risperdal was approved.”
Risperdal is an atypical anti-psychotic drug approved for certain types of schizophrenia, bipolar disorder, and irritability associated with autism. It is approved for adults with schizophrenia and as a combination therapy for adults with short-term acute manic/mixed episodes of Bipolar Disorder. Risperdal is approved for children and adolescents for irritability associated with autism; schizophrenia in adolescents, ages 13-17; and short term treatment of manic/mixed episodes of Bipolar Disorder, ages 10-17.
The complaint alleges that Janssen engaged in deceptive practices when it marketed Risperdal to physicians for uses unapproved by the Food and Drug Administration (“off-label uses”); failed to adequately disclose the drug’s potential adverse side effects to physicians; and withheld negative information contained in scientific studies concerning the safety and efficacy of Risperdal from physicians.
The complaint alleges that Janssen unlawfully marketed Risperdal for geriatric populations by targeting nursing home patients with Alzheimer’s disease, dementia, depression, sleep disorders and anxiety. The complaint also alleges Janssen targeted the pediatric population for many uses, including ADD (attention deficit disorder); ADHD (attention deficit hyperactivity disorder; conduct disorder and mood disorders.
Finally, the complaint alleges that Janssen promoted Risperdal for depression, anxiety; sleep disorders; anger management; PTSD (post traumatic stress disorder); mood enhancement and mood stabilization in adults and children.
Federal law prohibits pharmaceutical manufacturers from marketing their products for off-label uses; a physician, however, is allowed to prescribe drugs for off-label uses. Janssen must change not only how it markets Risperdal but also must stop the alleged false, misleading and deceptive promotion of the drug. Janssen is prohibited from selling drugs for “off-label” uses that the U.S. Food and Drug Administration has not approved. Among other matters, Janssen is now prohibited from:
- Allowing sales representatives to promote Risperdal to physicians who are unlikely to prescribe Risperdal for an FDA-approved use;
- Providing financial incentives to sales representatives to reward off–label marketing;
- Providing samples of Risperdal to physicians whose clinical practice does not deal with the uses set out in footnote 1; and
- Compensating physicians for attending Janssen promotional activities.
Approximately $4,000,000 of the settlement will be awarded for research or programs to provide alternatives to the use of atypical antipsychotics for managing the effects of Alzheimer's disease and/or dementia in elder long-term care facilities; for managing childhood and adolescent developmental and learning disorders; and/or for education and outreach programs directed at treatments for mental illness and/or for mental disorders. The balance will be deposited into the consumer fraud revolving fund as attorney’s fees and costs and to support the prosecution of similar cases.
The settlement is in the form of a consent judgment and must be approved by the Court.
Assistant Attorney General Noreen Matts handled the case for Attorney General’s Horne’s Consumer Protection and Advocacy Section.
Arizona was joined by Alabama, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, 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, Wyoming and the District of Columbia in the settlement.