GHB’s Path to Legitimacy: An Administrative and Legislative History of Xyrem

Abstract

This paper traces the path of a chemical compound (gamma-hydroxybutyrate, or GHB) from its status as an abused street drug to that of a legitimate, life-altering prescription treatment for a debilitating condition. It is the story of the public and private sectors working hand-in-hand to both protect the public from the detrimental effects of abuse while simultaneously ensuring that the thousands of Americans who need treatment are able to get it. It is also the story of an administrative and legislative system which, at least in this instance, seems to have worked to almost everyone’s satisfaction, despite the number of competing interests that were at stake. At the same time, this paper does not attempt to explain or evaluate medical claims about GHB or Xyrem. Instead, it is a historical account of the administrative and legislative path that led to GHB’s approval as a treatment for cataplexy related to narcolepsy. However, the paper does not take a linear approach to GHB’s history; instead the administrative and legislative processes are treated separately. Although the processes influenced each other in a myriad of ways, they were also distinct enough to require separate discussion. The story of Congress’ unprecedented bifurcated scheduling was surely a result, in part, of the success of Orphan’s clinical trials and pending New Drug Application (“NDA”), and the NDA was only allowed to go forward because of the bifurcated scheduling. Yet, to completely integrate the two stories would be needlessly confusing to the reader.