The Orphan Drug Act of 1983 provides tax incentives, patent protection, and research subsidies to firms for drugs, vaccines, and diagnostic agents if they are intended to treat a disease that affects less than 200,000 citizens. Explain how the Orphan Drug Act would affect drug development. Can you think of any tradeoffs from the act?
Introduction- Scientific development throughout the 20th century led to the development of many medical products and therapeutic advances for patients. But around the late 1970s it became increasingly clear that many citizens were being left out of these advances. One of the key reasons for this neglect was the small size of some patients populations. The relatively limited prevalence. The relatively limited prevalence of a particular disease acted as a barrier for commercial investment in the research and development required to show evidence of the safety and efficacy of treatment. Ironically, by the early 1980s, these ''rare disease'' affected 20-25 million patients who, together suffering from approximately 5000 rare disease some of which affects as few about a dozen individuals.
In response, organization were established in the Department of Health and Human Service and in FDA to promote the development of products to treat the "orphan" disease. At least as important was the grass roots efforts of patients and advocates affected by such rare disease as Gaucher disease, Tourette syndrome, Huntington disease, severe combined immunodeficiency, and many other disorders. They formed a coalition in the early 1980s, which evolved in to the National Organization for Rare Disorder, and which led in 1983, to the enactment of the Orphan Drug Act. As Abbey Meyers, the head of the organisation and the mother of a Tourette syndrome patient, later noted, " we look back on this adventure with a great sense of accomplishment and relief. It was opportunity for patients with rare disease to empower them selves.
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