Law Commons^™

Ignorance, Harm, And The Regulation Of Performance-Enhancing Substances, Lisa Milot

Scholarly Works

There is a disconnect between how legal and sporting authorities, on the one hand, and many elite athletes, on the other, view the use of performance-enhancing substances. While official and popular narratives portray the use of these substances as isolated examples of deviant behavior, to the elite athletes who daily push their bodies beyond societally normal limits of pain and risk, enhancement is oftentimes an accepted part of the job. As a result, efforts to regulate and detect athletes’ use of these substances have consistently captured only a small fraction of the use that exists.

This Article describes the ways …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

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 …

Racially-Tailored’ Medicine Unraveled, Sharona Hoffman

Faculty Publications

In June 2005, the FDA approved BiDil, a heart failure medication that is labeled for use only by African-Americans and thus is the first treatment of its kind. The drug likely portends a future of growing interest in "race-based" medicine. This phenomenon is emerging at the same time that scientists, in light of the Human Genome Project, are reaching an understanding that "race" has no biological meaning, and consequently, "racially-tailored" medicine is both puzzling and troubling.

This Article explores the reasons for the new focus on "racial-profiling" in medicine. It analyzes the risks and dangers of this approach, including medical …