Abstract
The United States Orphan Drug Act passed in 1983 provides four provisions to spur the development of medications for conditions that might otherwise have been abandoned. The Office of Orphan Drug Product Development was established to provide assistance in protocol development, and to administer a grants program. A tax credit incentive also was enacted but the most significant incentive has been the market exclusivity clause. Despite such measures, the act in the wake of technological and economic developments should continually be reexamined to enhance efficiency in development of orphan products, to ensure accessibility of these products to patients, and to minimize economic abuses by developers.
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Reider, C.R. The Orphan Drug Act: Provisions and Considerations. Ther Innov Regul Sci 34, 295–300 (2000). https://doi.org/10.1177/009286150003400137
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DOI: https://doi.org/10.1177/009286150003400137