A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers
Abstract
In FDLI's principal work on off-label medicine, this Chapter summarizes the evolution of off-label practices (including use, prescription, and promotion), tracks the development of the law on these issues, and discusses the future legal challenges that still await a firm resolution.
Suggested Citation
William M. Janssen. "A Historical Perspective on Off-Label Medicine: From Regulation, Promotion, and the First Amendment to the Next Frontiers" Off-Label Communications (First ed). Ed. Mark C. Levy. Washington, D.C.: Food & Drug Law Institute, 2008. i-217.