Janssen Pharmaceuticals Inc. and its parent company Johnson & Johnson have agreed to resolve charges of improper marketing and advertising of the powerful anti-psychotic drugs Risperdal and Invega in the largest multi-state consumer protection-based pharmaceutical settlement in history.
Janssen agreed to a record $181 million settlement, which includes settlements for 36 states plus the District of Columbia, according to New York Attorney General Eric T. Schneiderman.
In a complaint filed today in New York County Supreme Court, Attorney General Schneiderman charged that from 1998 through at least 2004, Janssen Pharmaceuticals engaged in deceptive and misleading practices when it marketed Risperdal, Risperdal Consta, Risperdal M-Tab and Invega for off-label uses. As a result of the states’ investigation, Johnson & Johnson agreed to change its marketing of Risperdal and Invega, and to cease promoting “off-label” uses of the drugs not approved by the U.S. Food and Drug Administration (FDA).
Janssen says the settlement is not an admission of wrongdoing or violation of any law or regulation. The company agreed to the settlement to resolve the concerns of the attorneys general under state consumer protection laws and to avoid unnecessary expense and a prolonged legal process. All parties have acknowledged that the payment is not a fine or penalty, Janssen stated
“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,” said Michael Yang, president, Janssen Pharmaceuticals, Inc.
New York’s Attorney General Schneiderman says pharmaceutical corporations’ illegal promotion of drugs for off-label uses must stop.
“Consumers, including parents of children with serious mental disorders and vulnerable patients should be able to trust their doctor’s advice without fear that drug companies are manipulating their physician’s independent judgment,” Schneiderman said. “This landmark settlement holds the companies accountable for practices that put patients in danger, and serves as a warning to other pharmaceutical giants that they must play by one set of rules. It goes further by ensuring that the corporations stop rewarding doctors for prescribing certain drugs or presenting scientifically-suspect studies as sound.”
Risperdal is an anti-psychotic medication used to treat mental illnesses including schizophrenia, bi-polar disorder and irritability associated with children and adolescence with Autism. Invega, which is derived from risperdone, is also marketed for the treatment of schizophrenia and bipolar mania. The complaint charged that Janssen promoted Risperdal for unapproved uses, including dementia in elderly patients, schizophrenia and bi-polar disorder in children and adolescents, and depression, anxiety, obsessive compulsive disorder, conduct disorder, post-traumatic stress disorder, and Alzheimer’s disease. Further, the complaint charged that Janssen concealed and misrepresented information regarding the side effects and efficacy of Risperdal thereby putting patients at risk.
The settlement prohibits Janssen from:
- Making false, misleading or deceptive claims regarding Risperdal or Invega;
- Promoting Risperdal or Invega for off-label uses;
- Promoting Risperdal or Invega by highlighting use for selected symptoms instead of diagnoses;
- Misusing continuing medical education (“CME”) programs to market Risperdal or Invega;
- Awarding grants to Health Care Professionals (“HCPs”) based on their prescribing habits;
- Presenting information and conclusions from a study that is not scientifically sound, or presenting information and conclusions in a manner that is not supported by the underlying study;
- Disseminating reprints containing off-label usage information.
The settlement also requires Janssen to:
- Report clinical research results regarding Risperdal or Invega in an accurate, objective and balanced manner;
- Disclose on its website a searchable listing of all HCPs and related entities who or which received any payments directly or indirectly from Janssen;
- Provide clear and conspicuous disclosure of the risks associated with the use of Risperdal or Invega in all of its promotional materials;
- Provide accurate, objective and scientifically balanced responses to requests for off-label usage information by doctors.
The other states that were part of the settlement include: Alabama, Arizona, Colorado, Connecticut, Delaware, District of Columbia, Florida, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming.