[20010725]RS20971_孤儿药物法案：第107届国会的背景和拟议立法.pdf

1 For more information see FDA Office of Orphan Products Development Program Overviewhttp:/www.fda.gov/orphan/progovw.htm. 2 For more information see the NORD website http:/www.rarediseases.org. Congressional Research Service The Library of CongressCRS Report for CongressReceived through the CRS WebOrder Code RS20971July 25, 2001Orphan Drug Act: Background and ProposedLegislation in the 107th Congressnae redactedAnalyst in Industrial OrganizationResources, Science, and Industry DivisionSummaryThe Orphan Drug Act (P.L. 97-414) was signed into law on January 4, 1983. TheAct provides incentives for pharmaceutical manufacturers to develop drugs,biotechnology products, and medical devices for the treatment of rare diseases andconditions. These products are commonly referred to as orphan products. Incentivesfor orphan product development include marketing exclusivity for orphan drug sponsors,tax incentives, and research grants. Since the Act was passed in 1983, the Food andDrug Administration (FDA) has approved 183 new orphan products. Critics of the Actargue that, because the Act relies on market-oriented strategies to promote orphan drugdevelopment, overpricing of drugs can limit patie