Off-label use is the practice of prescribing medications for uses other than those approved by the FDA. Many doctors engage in the practice. However, according to a recent survey, a substantial minority of doctors mistakenly believe that certain off-label uses are FDA-approved. These off-label uses are often not supported by scientific evidence. "Overall, physicians were able to correctly identify the FDA-approved status of just one half (mean 55%) of the 22 drug-indication pairs (i.e. a particular drug prescribed for a particular condition) that were included in the survey." The mistaken belief that off-label uses are FDA approved may encourage some doctors to practice off-label prescribing. The study was published in the journal Pharmacoepidemiology and Drug Safety. The study’s authors urge the need for physicians to learn more about off-label drug use and whether there is support for such uses, especially uses that are ineffective or have unacceptable risks.
The FDA approves drugs for specific indications, and regulates the marketing of drugs. Drug makers are prohibited from promoting their drugs for off-label uses. However, doctors are free to prescribe approved drugs for uses not indicated in the drug’s label. Patients are often not aware that they are being prescribed a drug for an off-label use.