In 1983, Congress passed the Orphan Drug Act (ODA) in an attempt to counteract the economic downsides and other challenges companies faced in conducting research and developing new treatments for niche diseases with very small patient populations; so-called “orphan diseases.”
The ODA established the FDA’s ability to grant Orphan Drug Designations (ODD) to products intended to treat, diagnose, or prevent a rare disease or condition. With ODD status, companies can avail themselves of the various orphan drug development incentives established by the ODA.
