96 Stat. 2049.pdf

Public Law 97-414, also known as the Orphan Drug Act, was enacted on January 4, 1983, to facilitate the development of drugs for rare diseases and conditions. The law finds that many rare diseases, such as Huntington's disease and muscular dystrophy, affect small numbers of individuals, and adequate drugs have not been developed due to the high costs and low potential sales. The law aims to provide financial incentives and reduce development costs for orphan drugs. It amends the Federal Food, Drug, and Cosmetic Act by adding provisions for the development of orphan drugs, including recommendations for investigations, designation of drugs for rare diseases, protection for unpated drugs, and open protocols for investigations. The law provides a seven-year period of exclusivity for approved orphan drugs, during which the FDA may not approve another application for the same drug for the same disease or condition, unless the original holder cannot assure sufficient quantities or provides consent.