Off-Label Drug Use
The U.S. Food and Drug Administration (FDA) must approve all prescription drugs that are marketed in the United States. The goal is to ensure that the prescription is safe and effective for use by the public. However, most people do not realize that doctors often prescribe prescription drugs for conditions that are not actually FDA approved. This is considered "off-label" prescribing. The medical practice of off-label prescribing is legal, however, it is not legal for drug manufacturers to market or promote their drugs for off-label uses. The FDA does not wish to regulate how a doctor treats his/her patients; in many cases, off-label treatments can reduce a patient’s suffering and improve their health. However, using a drug for a purpose other than for which it was clinically tested and approved can have some serious health consequences.
A pharmaceutical company or medical device provider must submit all new drugs and medical devices to the FDA for review and approval. The company also provides documentation from extensive research and clinical trials. The approval process is often lengthy and expensive for drug companies. Once approved, the drug/device is given an FDA-approved label. The label documents information on the drug, the dosage of the drug, the administration of the drug and the condition(s) for which the drug was approved. Any deviation from the instructions of the drug’s label is considered "off-label" use.
Concerns over off-label use of drugs and medical devices stem from the fact that these off-label uses are not subject to the same strict standards that govern FDA approved drugs and medical devices. Often medical manufacturers perform small studies and/or clinical trials to gain information and physician opinions on off label uses. The studies generally have smaller populations of patients and a shorter time frame than full scale testing. The studies may be industry sponsored, thus possibly less impartial. Sometimes drugs that are FDA approved for adults may be recommended for children with no FDA scrutiny and limited research.
It is important for Americans to be aware of the practice of Off-Label drug use. When a new drug is prescribed, the patient should be comfortable asking their doctor questions about the drug. Ask if it is FDA approved for your condition. If your doctor can not answer this, you can get a second opinion or research the drug on the FDA website. If the drug is not approved for your condition, then ask the doctor for supporting research and documentation of the off-label uses of the drug. You can also ask what drugs ARE FDA approved for your condition and evaluate the pros and cons of each drug. Additionally, sometimes off-label uses of a drug are not approved by your insurance company, so also be sure to check with your insurance company to see if the drug will be covered.
If you believe that you or a loved one were injured by a non-FDA approved use of a drug or medical device, you are welcome and encouraged to contact Brett H. Oppenheimer, PLLC at (502) 242-8877.