The Orphan Drug Act

The Orphan Drug Act is a U.S. law enacted in 1983 to encourage pharmaceutical companies to develop treatments for rare diseases, also known as orphan diseases, which affect fewer than 200,000 people. It provides financial incentives, such as tax breaks and marketing exclusivity for seven years after approval, to stimulate research and development for these neglected medical needs. By making it more financially viable for companies to invest in rare diseases, the law aims to improve access to treatments for patients with conditions that might otherwise be overlooked due to limited profit potential.