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FDA Regulates Approval of Drugs, Not How they are Prescribed

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People generally understand that the U.S. Food and Drug Administration regulates drug approval, but many would be surprised to learn that the FDA does not control how approved drugs are really prescribed.

Doctors are given great latitude to prescribe any drug for any reason that they deem medically appropriate, and are not required to tell the patient that the medication is being used for something other than the condition it was approved for. The process, commonly known as “off-label prescribing,” is legal and extremely common. Pharmaceutical companies are not permitted to market medications for off-label uses, however, and this practice has led to several large legal settlements.

What is “Off-Label?”

Off-label generally means that a medication is not being prescribed for a use specified in the FDA’s approved packaging label or insert included with the drug. The label is a written document that gives detailed information about approval uses and dosages, based on the results of clinical studies that the drug maker provided to the FDA to gain approval. According to WebMD, more than one-fifth of the outpatient prescriptions written in the U.S. are for off-label uses.

Doctors who choose to prescribe medications for a use other than what they were approved for have many significant responsibilities, including:

There are some risks and benefits to off-label prescribing, and it is often helpful when patients have exhausted all other approved medication options. Cancer treatment often includes the use of off-label drugs for chemotherapy, since a drug approval for one specific type of cancer may also target many kinds of tumors. In these circumstances, off-label use of a drug represents the standard of care. Other common off-label uses of prescription medications include:

Because the FDA makes it clear that it does not regulate the practice of medicine, off-label drug use has become common, and occurs in virtually every medical specialty, particularly those in which the patient population is less likely to be included in clinical trials – pregnant women, children, or the elderly. Off-label prescription drug use can be a polarizing term because it is associated with both great benefit as well as great harm to patients, and health care professionals must continually education themselves about OLDU and its risks and benefits to patients.

We encourage all our patients to ask their doctor about the medication they are prescribing. Ask if the medication prescribed is FDA approved for the condition being treated. Ask why they think this medication would be better than another type or some other treatment. Ask what are the material risks of the medication and have they heard of any adverse side effects from it.

Asking these important questions will make you a more informed patient and hopefully keep you and your family safe from a prescription error or injury.

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