The Department of Justice and qui tam plaintiffs have settled cases involving “off-label marketing” of prescription drugs for billions of dollars. In such fraud cases, companies seek to increase their revenue using various off-label marketing methods including promoting drugs to physicians for the treatment of unapproved diseases, indications of a disease, patient populations, and/or dosages. Whistleblowers may bring False Claims Act qui tam actions where government health care programs such as Medicaid, Medicare, and TRICARE are billed for drugs marketed for off-label purposes.
New pharmaceutical drugs cannot be marketed in the United States unless the sponsor of the drug demonstrates to the satisfaction of the federal Food and Drug Administration (“FDA”) that the drug is safe and effective for its intended uses. Approval of the drug by the FDA is the final stage of a multi-year process of study and testing. The FDA does not approve a drug for treatment of medical conditions in general. Instead, a drug is approved for treatment of one or more specific medical conditions for which the drug has been tested in patients. The specific FDA-approved use is called the “indication” for which the drug may be prescribed. The FDA also specifies particular dosages determined to be safe and effective for each indication.
Under the Food and Drug Administration Modernization Act of 1997 (“FDAMA”), if a manufacturer wishes to market or promote an approved drug for alternative uses other than its approved indication, the manufacturer must re-submit the drug for another series of clinical trials similar to those for the initial approval. Until subsequent approval of the newly sought use has been granted, the unapproved use is considered to be “off-label.”
Off-label refers to the use of an approved drug for any purpose, or in any manner, other than what is described in its labeled indication. Off-label uses include treating a condition not indicated on the label, treating the indicated condition at a different dose or frequency than specified in the label, or treating a different patient population (for example, for treatment of children when the drug is approved only to treat adults).
The FDA is responsible for ensuring that a drug is safe and effective for the specific approved indication. The FDA, however, does not regulate the practice of medicine. Once a drug is approved for a particular use, the FDA does not prohibit physicians or other relevant licensed medical practitioners from prescribing the drug for uses that are different than those approved by the FDA. Although physicians and other relevant licensed medical practitioners may prescribe off-label uses, the law generally prohibits the marketing or promotion of a drug for a use that the FDA has not approved.
For example, in 2009, pharmaceutical company Eli Lilly and Company agreed to pay $1.415 billion to the United States which included a criminal fine as well as a civil settlement for promoting the drug Zyprexa for uses not approved by the FDA. The FDA originally approved Zyprexa for the treatment of manifestations of psychotic disorders and later expanded its approval for short term treatment of schizophrenia and bipolar disorder. Although the drug was never approved for the treatment of dementia or Alzheimer’s dementia, Eli Lilly created marketing materials and trained its sales force to promote Zyprexa to physicians treating patients in nursing homes and assisted-living facilities with disorders such as dementia and Alzheimer’s dementia.
Similarly, in 2012, Amgen Inc. agreed to pay $612 million to resolve False Claims Act lawsuits where Amgen sold the drug Aranesp with the intention that it be used at off-label doses that the FDA specifically considered and rejected and for an off-label treatment that the FDA never approved.
Additionally, in 2018, Abbott Laboratories and AbbVie Inc. settled a False Claims Act qui tam action for $25 million which involved allegations of off-label marketing of the drug TriCor in addition to payment of kickbacks. TriCor received FDA approval for indications to treat patients with hypertriglyceridemia, mixed dyslipidemia, or hypertriglyceridemia. Abbott marketed the drug off-label for not FDA-approved uses including: (1) use in treating, preventing, or reducing cardiovascular events and other cardiac health risk; (2) use in combination with statin drugs, and (3) use as a first-line treatment of diabetic patients, including treatment to prevent or reduce cardiac health risks in diabetic patients.
For more information regarding potential whistleblower claims involving off-label marketing, please contact Brady & Associates, 10985 Cody Street, Suite 135, Overland Park, Kansas 66210, or call (913) 696-0925.