The Orphan Drug Act (ODA) Oral History Project
This project seeks to reassess the U.S. Orphan Drug Act (ODA) contemporaneously by documenting, retelling, and examining the back stories of its development as well as current experiences through case studies of particular disease areas. The ODA was passed, in the early 1980s, in order to create opportunities for therapeutic R&D often for life threatening conditions that through their rarity, in the US, would likely not have had a chance. In particular, we believe by retelling individuals' stories of the early days, we will draw out important insights about how the public policy issues were framed and the work that heterogeneous groups and individuals had to do to pass and implement the Act that may be important for better understanding the complex world of biopharmaceutical R&D, regulation, and patient-industry-government collaborations today.
Staff: Pei Koay, Maureen Caulfield