You may be trying to access this site from a secured browser on the server. Please enable scripts and reload this page.
Turn on more accessible mode
Turn off more accessible mode
Skip Ribbon Commands
Skip to main content
Turn off Animations
Turn on Animations
Skip Main Navigation
Skip All Navigation
Albany Law Journal of Science and Technology
Balancing on the Edge: The Implications and Acceptability of Off-Label Drug Use
19.0000000000000 ALB. L.J. SCI. & TECH. 633 (2009)
Off-label drug use presents a unique paradox: it can both aid and harm the patient. Typically, the Food and Drug Administration (“FDA”) has an arduous process for pharmaceutical companies to go through to have a drug approved. The purpose of this is to certify the safety and efficacy of the drug. However, the use of off-label drugs, those that are not used for the approved indications by the FDA on the label, is prevalent. Estimates have shown that off-label drug use varies extensively from 21% to over 50% for specific medications or drug classifications. The study further noted that some uses were a “logical extension” while others were “therapy for indications distinctly different from those for which the drug was approved.” Off-label drug use thus falls in the gray area between constituting human experimentation and a widely accepted practice by physicians.