Off-Label Use for Drugs & Medical Devices

Once a new drug or medical device is cleared for marketing by the U.S. Food and Drug Administration (FDA), the drug or medical device is available to doctors and patients. In the U.S., FDA regulations permit doctors and other healthcare providers to prescribe approved drugs and medical devices for indications other than the disease or condition for which they are approved—this is called “off-label use.”

Off-label use does not mean unsafe use. The FDA allows doctors to choose the best drug or medicine to treat their patients. Doctors may prescribe a drug or medical device in a way that’s demonstrated positive outcomes but isn’t "indicated" or FDA-approved for that specific use. If doctors weren’t allowed to prescribe off-label, lengthy FDA approval processes for each drug or medical device might prevent patients from receiving beneficial therapy.

For example, stents are metal scaffolds that can be implanted into a diseased vessel to help open it. Initially, stents were only FDA-approved for arteries. However, doctors learned they could also use stents to open closed veins. For many years, stents have been used off-label to help patients with closed veins successfully.

It's important for doctors and patients to discuss the best treatment method and all drugs and medical devices available to treat a condition. However, pharmaceutical and medical device companies are prohibited from promoting their products for any other purpose unless they receive FDA approval for a new indication. Visit the FDA for more information on off-label drug use.