Orphan Drugs

The Orphan Drug topic focuses on the development of treatments, diagnostics, interventions, and devices for rare diseases, which are defined as diseases affecting fewer than 200,000 individuals in the United States.

The U.S. Orphan Drug Act (1983) encourages development of these therapeutics by tax breaks and a seven-year monopoly on drug sales. These incentives promote the development and manufacturing of such therapeutics, which otherwise might not be profitable because of the small potential market. In the United States, a drug or biologic is granted Orphan Drug Designation by the Office of Orphan Products Development (OOPD), a special office in the U.S. Food and Drug Administration.