Medicine Approvals for Rare Diseases Drug Approvals for Rare Diseases Have Increased from Fewer than 10 to More than 160 Rare diseases are those that affect 200,000 or fewer people in 160 the U.S. In total, 25 million 160 Americans have rare diseases. Drug Approvals 120 108 The Orphan Drug Act (ODA) was passed in 1983 to encourage the 80 research and development of medicines to treat rare diseases. Since then, the FDA has approved 40 more than 200 medicines for rare diseases. 10 0 1970's 1984–1994 1995–2005 Note: All medicines approved for rare diseases include first-line approvals and subsequent approvals for new disease areas Sources: FDA, Office of Orphan Product Development, List of All Approved Orphan Products Through the Year 2005 and Orphan Products Development, at http://www.fda.gov/orphan; NIH, Office of Rare Diseases, “Biennial and Annual Report on the Rare Diseases Research Activities at the National Institutes of Health, FY 2004,” 2005.
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