We often hear about drugs being prescribed “off-label.” Many patients have questions about what this means. Is it safe? Is it legal? How can we know that off-label use will help us get better?

Off-label use is the practice of prescribing pharmaceuticals for an unapproved indication, age group, dose or form of administration. We will explain more about this shortly.

But first, let’s look at how drugs are approved for use in our country.

In the U.S., the Food and Drug Administration Center for Drug Evaluation and Research review’s a company’s New Drug Application for data from clinical trials to see if the results support the drug for a specific use or indication.

If the drug is found to be safe and effective, it can be marketed for the specific condition for which it was approved by the FDA.  Until recently, however, it was against FDA regulations for pharmaceutical companies or their representatives to market a drug for any conditions for which the FDA hadn’t approved. 

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