Standards, orphan drugs, and pharmaceutical markets

Standards have been integral to the development of modern medicine. From the international classification of illnesses to the promotion of evidence-based medicine, standards, protocols, and guidelines have shaped the conduct of medical practitioners and the delivery of health care since the late nineteenth century (Timmermans and Berg, 2003). In the case of medicine, standards offer the promise of ensuring the safety of pharmaceutical products or medical devices. Standards are further used to ensure the consistency of how data is gathered, how decisions are made over organ transplants (Hogle, 1995) and the sequence of procedures that should be used to resuscitate patients following cardiac arrest (Timmermans and Berg, 1997). Standardization involves making objects or social practices conform to particular technical and social visions of order. As scholars within the field of science and technology studies have documented, the work of standardization is intimately bound up with the construction of techno-economic networks (Fujimura, 1992, Latour, 1988). Standards are integral to the development of large-scale systems such as international clinical trials (Petryna, 2009), and to the minuscule calibrations of instruments on the lab bench (Jordan and Lynch, 1998). Here, standards play a double-edged role: they facilitate the creation of enduring networks that pattern technical, economic, and social activity, but they close off certain technological and policy options