Off-Label Promotion of Drugs and Medical Devices

Typically, prosecutors seek to punish off-label promotion with civil penalties under the False Claims Act predicated on billings to Medicare and Medicaid and criminal prosecution under the Food, Drug, and Cosmetic Act. Federal prosecutors have entered into criminal and civil settlements that included off-label allegations with Pfizer, Eli Lilly, Serono, Astra Zeneca, Cephalon, Bristol-Myers Squibb, and Schering Plough, among others. Several device manufacturers have entered into off-label settlements too. The DOJ has made off-label investigations a continuing priority, which means off-label cases will be among the largest cases the Department prosecutes over the next several years.

The rules relating to the off-label marketing of drugs and devices are at times inconsistent. In order to sell a drug or medical device, the manufacturer must receive FDA approval, which means the FDA has determined the drug has efficacy (it works) and is safe enough for use. The FDA determines what illnesses the manufacturer can say the drug treats (“approved indications”) and how the drug should be administered (“on-label administration”). Federal law defines “off label” use of an approved drug as any use that is not included within the FDA-approved label. Manufacturers are prohibited from promoting drugs for such “unapproved uses.” See 21 U.S.C. ” 355(a); 331(d). Notably however, although the FDA regulates the manufacture, labeling, and promotion of drugs, it does not regulate the practice of medicine. Once the FDA approves a drug for any use, physicians and other providers are free to prescribe it for off-label indications and administration. See 12 FDA Drug Bulletin 4 (April 1982). Providers may administer the drug or device off-label, alter dosing or means of administration (e.g., intravenous or subcutaneous), or use drugs and devices labeled for adults with children.