What does the Orphan Drug Act relate to?

The Orphan Drug Act, enacted in 1983, was designed to encourage the development of treatments for rare diseases and conditions, specifically those affecting fewer than 200,000 patients in the United States. This legislation provides various incentives to pharmaceutical companies, such as tax credits for clinical research and extended exclusivity periods for approved orphan drugs, making it more feasible for companies to invest in the development of these medications that might not otherwise be economically viable. By focusing on conditions that affect a small patient population, the Act plays a crucial role in ensuring that individuals with rare diseases have access to potentially life-saving therapies, which might otherwise be neglected in the pharmaceutical market.