Off Label

A drug product is approved for a certain indication, a method of administration according to controlled clinical studies. The FDA approves the product for that indication or label based on the contents of the New Drug Application. Health care workers may use the drug product “off label,” which means not according to the approved indication or method of administration.

Physicians can use drug products off label without the requirement of submitting an Investigational New Drug Application or requiring institutional review board approval. However, the physician must follow good medical practice.

Examples of drug products used off label are pediatric and oncology medications. This can be a major issue, because there are no data available to learn how to administer the drug product safely.

A sponsor can publish in scientific journals, regarding the safety and effectiveness or benefits of “off label” uses for their marketed drug products. However, the FDA has policies for the use of promotional materials for off-label use. The FDA has proposed the provisions of the Food and Drug Administration Modernization Act (FDAMA) of 1997 allowing manufactures and sponsors of drug products greater flexibility to disseminate information on “off label” use.