Pharmaceutical manufacturers Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals, Inc., both subsidiaries of Johnson & Johnson, will pay more than $81 million to resolve criminal and civil liability in the illegal promotion of the epilepsy drug Topomax.
According to an agreement reached with the government, Ortho-McNeil Pharmaceutical will plead guilty to a misdemeanor and pay a $6.14 million criminal fine for the misbranding of Topamax in violation of the Food, Drug and Cosmetic Act.
The Food and Drug Administration approved Topamax as an anti-epileptic drug, for the treatment of partial onset seizures, but not for any psychiatric use. Once a drug is approved by the FDA, a manufacturer may not market or promote it for any use not specified in its new drug application. The unauthorized uses are also known as "unapproved" or "off-label."
Ortho-McNeil Pharmaceutical allegedly promoted Topamax for off-label psychiatric uses through a practice known as the "Doctor-for-a-Day" program. According to federal officials, Ortho-McNeil hired outside physicians to join sales representatives in their visits to the offices of healthcare providers and to speak at meetings and dinners about prescribing Topamax for unapproved uses and doses.
In addition to the fine, Ortho-McNeil-Janssen Pharmaceuticals will pay $75.37 million to resolve civil allegations under the False Claims Act that it caused false claims to be submitted to government healthcare programs. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.
"Working with our federal and state partners, we will take action against pharmaceutical companies that promote their drugs for off-label uses," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "This type of unlawful marketing undermines the FDA's important role in deciding which drugs are safe and effective for consumers and costs the taxpayers billions of dollars each year."
The civil settlement resolves two lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act, which allow private citizens with knowledge of fraud to bring civil actions on behalf of the United States and share in any recovery. The two cases were filed in the District of Massachusetts. As part of the resolution, the whistleblowers will receive payments totaling more than $9 million from the federal share of the civil recovery.
Ortho-McNeil-Janssen Pharmaceuticals has also agreed to sign an expansive corporate integrity agreement with the Office of the Inspector General of the Department of Health and Human Services.