Johnson & Johnson and its drugs unit will pay $2.2 billion to the U.S. government and 45 states to end civil and criminal investigations into unethical drug marketing practices.
Four whistleblower lawsuits exposed kickbacks to pharmacists for marketing pharmaceuticals for purposes the drugs had no Federal Drug Administration approval for.
The settlement agreed to by Johson & Johnson and its Janssen Pharmaceuticals, Inc. unit covers the marketing of psychotropic drugs Risperdal and Invega, according to a statement from the New York attorney general.
The company “made false and misleading statement about the safety and efficacy of Risperdal, and paid illegal kickbacks to health care professionals and long-term care pharmacies to induce them to promote or prescribe Risperdal to patient populations, such as children, adolescents and the elderly, for which there was no FDA approval,” Attorney General Eric T. Schneiderman said in a release.
Risperdal is recommended for schizophrenia, but was marketed for ADHD, dementia and other disorders, the release said. Invega was also marketed for uses for which was not approved and could have been harmful to patients, Schneiderman said.
"Parents of children with hyperactivity disorders and other vulnerable patients should be able to trust their doctor’s advice without fear that drug companies are manipulating their physician’s judgment. This settlement should serve as a warning to pharmaceutical corporations: the illegal promotion of drugs for off-label uses must stop,” Schneiderman said.
Janssen will plead guilty in federal court in Philadelphia to violations of the U.S. Food, Drug, and Cosmetics Act and has agreed to pay $400 million in criminal fines.
More than $523 million of the civil settlement will go to Medicaid and Medicare programs. The $2.2 billion total includes $1.72 billion in civil settlements with federal and state governments.
Janssen and Johnson & Johnson also have agreed to enter into a corporate integrity agreement with the U.S. Department of Health and Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.
In recent years, the U.S. government has cracked down on the pharmaceutical industry's aggressive marketing tactics, which include pushing medicines for unapproved uses and incentives for pharmacists and health professionals. While doctors are allowed to prescribe medicines for any use, drugmakers cannot promote them in any way that is not approved by FDA.
Last year British drugmaker GlaxoSmithKline paid a record-setting $3 billion in fines to settle criminal and civil violations involving 10 of its drugs.