Prescribing Approved Drugs for Nonapproved Uses: Physicians’ Disclosure Obligations to Their Patients

Abstract

A large part of the everyday practice of medicine consists of prescribing drugs for the purpose of curing or alleviating patient ills. In most cases, a drug must be approved for specific uses by the federal government before it becomes available to be prescribed by a physician. However, once a drug has received regulatory approval for a specific medical use, the physician may prescribe it for any purpose, approved or not. The prescribing of drugs for nonapproved uses is a common medical practice. This article discusses the informed consent implications raised by this practice, and argues that the physician should disclose to the patient the legal status of a drug prior to prescribing it for a purpose which has not been governmentally approved.Relying upon the Constitution's Commerce Clause, Congress has vested jurisdiction over all “drugs” involved in “interstate commerce” in the federal Food and Drug Administration (FDA), a division of the Public Health Service (PHS) of the Department of Health and Human Services (DHHS).