The Military’s Need For “Speed”: A Case Study On The FDA’s Regulation Of Off-Label Prescriptions

Abstract

This paper is a case study in the legality and ethics of prescribing amphetamines (“go-pills”) to military aviators for fatigue management, a practice that has not been approved by the Food and Drug Administration (FDA). Currently, the FDA has very little authority to regulate this type of “off-label” prescription and would have to adopt its “Proposed Regulation on Prescribing for Uses Unapproved by the FDA” to have any chance of controlling the use of “go-pills” in the military. In the alternative, the agency could only regulate the drug indirectly through total withdrawal or limited distribution. However, many off-label prescriptions improve the practice of medicine and these alternative approaches would deny patients use of the drug for those indications that have been approved by the FDA. Therefore, this paper proposes an FDA “disapproval process” for those off-label prescriptions that are an imminent danger to public health.