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Off-Label PrescribingOff-label prescribing, also known as unapproved use, is the physician practice of prescribing a drug or medical device for a purpose different from one of the indications for which the product is approved by the Food and Drug Administration (FDA). The practice is widespread. Although there are no accurate data, estimates run as high as 60% of all drug prescriptions written in the United States in a given year, including a large proportion of chemotherapy and pediatric prescribing.(1)
The practice raises a number of legal and ethical issues. Is off-label prescribing a form of human experimentation, triggering the safeguards established to protect human subjects? When is it appropriate in that it conforms to the standard of care? Could a failure to prescribe off-label leave the physician vulnerable to a malpractice suit? Does the physician have a duty to inform the patient that the product is being prescribed off-label? In prescribing a drug for an unapproved use, does the physician act as a "learned intermediary," thereby relieving the drug manufacturer of liability for resulting patient harm? How does the FDA regulate off-label prescribing? Can a manufacturer promote a product for an off-label use?
When Is Off-Label Prescribing Appropriate?From a legal and ethical standpoint, off-label use represents a delicate balance between the regulatory objective of protecting patients from unsafe or ineffective drugs and medical devices on the one hand, and, on the other hand, the prerogative of physicians to use their professional judgment in treating patients.
In the world of law, where matters are rarely clear-cut, there are a few certainties about off-label use. First, it does not violate FDA law. The agency itself acknowledges this, its Center for Drug Evaluation and Research, stating, for example: "Neither the FDA nor the Federal government regulate the practice of medicine. Any approved product may be used by a licensed practitioner for uses other than those stated in the product label."(2) In Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350 (2001), the U.S. Supreme Court observed that "'off-label' usage of medical devices (use of a device for some other purpose than that for which it has been approved by the FDA) is an accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering with the practice of medicine."
Second, it follows from the fact that off-label use is not illegal that using a product off-label does not by itself constitute malpractice (Femrite v. Abbott Northwestern Hospital, 568 N.W.2d 535, 542 (Minn. Ct. App. 1997) (pedicle screws). On the contrary, as a Tennessee appellate court observed in Richardson v. Miller, 44 S.W.3d 1, 13, n.11 (Tenn. Ct. App. 2000): "Because the pace of medical discovery runs ahead of the FDA's regulatory machinery, the off-label use of some drugs is frequently considered to be 'state-of-the-art' treatment. "In some circumstances, an off-label use of a particular drug or device may even define the standard of care."
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