117 Penn St. L. Rev. 407 (2012).


This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to generate unbiased research on off-label uses, which, in turn, would create a safe harbor for drug companies to widely disseminate studies generated through this process to the medical community. Finally, Part V will present concluding thoughts on the overarching policy considerations driving the need for legislative reform.