The Medical, Social, and Financial Dimensions of Orphan Drugs
RGA6216 / 4 q.h.
Formerly RA 3216.
Examines the orphan drug development process, from discovery to FDA regulatory approval to postapproval marketing and distribution. Using selected case studies, offers students an opportunity to gain a strong understanding of how novel biomedical discoveries are translated into products used to treat relatively rare diseases. Topics include the role of patient advocacy groups in lobbying for research and development, the influence of gender and racial considerations on policy decisions, and the capacity of the federal government to support the research and commercialization of orphan drugs. The course situates its study of orphan drugs within the context of pharmaceutical firms’ reluctant shift away from big blockbuster drugs in favor of more personalized medicines. Prereq. RGA 6201.
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