COLUMBUS, Ohio – Ohio’s share of a $2.2 billion settlement between the federal government and pharmaceutical giant Johnson & Johnson and one of its subsidiaries will be more than $52 million.
Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, Inc., have agreed to pay over $2.2 billion to resolve criminal and civil allegations of promoting three prescription drugs for off-label uses not approved by the Food and Drug Administration.
Ohio’s portion of the settlement is $52.7 million, Attorney General Mike DeWine said.
“Johnson & Johnson and Janssen promoted and marketed these drugs for uses that were not approved by the Food and Drug Administration and misled the public in regards to their use,” DeWine said.
The allegations also included paying kickbacks to physicians and pharmacies to recommend and prescribe Risperdal and Invega, both antipsychotic drugs, and Natrecor, which is used to treat heart failure, for “off-label” uses. Once the FDA approves a drug as safe and effective, a manufacturer cannot market or promote a drug for an “off-label” use, i.e., any use not specified in the FDA-approved product label, DeWine said.
In a news conference, Attorney General Eric Holder called the actions “shameful” and said they violated the trust of patients. He said the Justice Department will “hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
As part of the settlement, the companies will enter into a Corporate Integrity Agreement with the Department of Health and Human Services, which will monitor their future marketing practices.
Janssen will also plead guilty in federal court to a criminal misdemeanor charge of misbranding Risperdal in violation of the Food, Drug, and Cosmetic Act. As part of the criminal plea, Janssen has agreed to pay an additional $400 million in criminal fines and forfeitures.