What is the purpose of the Orphan Drug Act of 1983?

The purpose of the Orphan Drug Act of 1983 is to provide tax incentives and other benefits for the development of drugs that address rare diseases affecting fewer than 200,000 patients in the United States. This legislation was designed to encourage pharmaceutical companies to invest in the research and production of treatments for rare conditions that might not otherwise be financially viable due to a limited market. By offering incentives such as tax credits and extended market exclusivity, the act aims to stimulate the development of therapies for these less common but often serious health conditions, ultimately improving patient access to necessary medications.

The other options do not align with the focus of the Orphan Drug Act: categorizing controlled substances pertains to drug enforcement policies; expediting drug reviews for common diseases relates to different regulations aimed at addressing more prevalent health issues; and regulating drug manufacturing processes involves ensuring quality and safety in production rather than focusing on rare diseases specifically.