Popis: |
Patients’ difficulty obtaining medications for rare diseases and the advocacy of mothers led to a compelling and convoluted story of the development of the Orphan Drug Act (ODA) of 1983. While valid criticisms of the ODA remain, articles continue to be published on its ongoing beneficent influence. As hoped, ODA tax incentives stimulated research to develop pharmaceutical interventions for rare diseases. The initial ODA defined rare diseases qualitatively, but the 1984 Amendments established that |