The Orphan Drug Act (ODA), a federal law established in 1983, aims to encourage pharmaceutical companies to develop drugs for rare diseases with small markets
- Focused on rare diseases affecting less than 200,000 patients in the U.S.
- Over 55 million people are estimated to suffer from a rare disease in the U.S. and Europe
- Global estimates are between 5,000 and 7,000 rare diseases
- ODA provides multiple financial incentives for orphan drug development
- Although the patient population is small orphan drugs have a higher per patient cost, acting as an incentive to develop drugs for orphan diseases
- Since 1983, more than 400 orphan products have received U.S. market authorization
- Japan and Europe have enacted similar legislation