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The Impact of the Orphan Drug Act on the Development and Advancement of Neurological Products for Rare Diseases: A Descriptive Review
Author(s) -
Burke K A,
Freeman S N,
Imoisili M A,
Coté T R
Publication year - 2010
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.2010.193
Subject(s) - orphan drug , incentive , action (physics) , clinical pharmacology , drug development , medicine , business , expert opinion , drug , pharmacology , intensive care medicine , bioinformatics , economics , biology , physics , quantum mechanics , microeconomics
Many neurological diseases or conditions are rare disorders. The Orphan Drug Act (ODA) of 1983 was promulgated to promote the development of products for such conditions. In this Opinion piece, we discuss how the ODA has affected neurological diseases, note how current and future sponsors (any person(s) or entity (i.e., academic, corporate body, individual, manufacturer) that applies for an official regulatory action) of products for rare neurological diseases can take advantage of ODA incentives, identify areas of success and continuing needs, and review data that can help drive the future development of products for rare neurological conditions. Clinical Pharmacology & Therapeutics (2010) 88 4, 449–453. doi: 10.1038/clpt.2010.193