US definition of a rare disease or condition under the Orphan Drug Act
less than 200,000 persons in the United States
people, US
“affects less than 200,000 persons in the United States, or”
FDA, Orphan Drug Act relevant excerpts (Section 526 of the FD&C Act), 2026-11-06
- Kind of source
- Registry or statistics office
- Read on
- 2026-11-06
- Daily check
- Quote found at the source on 2026-11-06
- What to know
- The statute reads 'less than' 200,000. A second route exists for diseases affecting more people where drug costs cannot be recovered from US sales. FDA page has no stated date, so the read date is used.
Used in
Kept as evidence; no figure on the platform is computed from it yet.