The Orphan Drug Act was enacted in 1983 in the United States to encourage the development of treatments for rare diseases, often referred to as orphan diseases. These conditions affect fewer than 200,000 people, making it financially challenging for pharmaceutical companies to invest in research and development. The Act provides incentives such as tax credits, grant funding, and seven years of market exclusivity for drugs approved for these rare conditions.
By offering these benefits, the Orphan Drug Act aims to stimulate innovation and ensure that patients with rare diseases have access to necessary treatments. This legislation has led to the approval of many new drugs, improving the quality of life for individuals affected by conditions that might otherwise be overlooked by the healthcare industry.