Orrin Hatch: “in light of recognition of Rare Disease Day, I wish to speak about orphan drug exclusivity and trade promotion…”

“in light of recognition of Rare Disease Day, I wish to speak about orphan drug exclusivity and trade promotion authority. Congress enacted the bipartisan Orphan Drug Act, ``ODA'', of 1983, Pub. L. 97-414, to address a longstanding unmet need to develop new treatments, diagnostics, and cures for rare diseases and disorders. I am proud to be one of the lead Senate sponsors of the ODA, which was passed with overwhelming bipartisan support. This act and the Rare Diseases Act of 2002--which I also championed--created financial incentives for the research and production of orphan drugs, including 7 years of market exclusivity, tax credits, and research grants, and also established the Orphan Products Board at FDA and the Office of Rare Diseases under the National Institutes of Health. The purpose of these acts was to encourage the development of new ``orphan'' treatments, diagnostics, and cures for the millions of Americans with rare disease who lacked access to effective medicines because the existing incentives were insufficient to develop and market drugs for such small groups of patients. The ODA has been enormously successful. Before Congress enacted the ODA in 1983, the Food and Drug Administration, FDA, approved only 38 drugs in the United States specifically to treat orphan diseases. From the passage of the ODA in 1983 until May 2010, the FDA approved 353 orphan drugs and granted orphan designations to 2,116 compounds.…”