What US Orphan Drug Act (21 USC ch 9): Incentives for Rare Disease Drugs requires
The Orphan Drug Act, codified within the Federal Food, Drug, and Cosmetic Act (21 U.S.C. ch. 9, sections 360aa to 360ff), creates incentives to develop drugs for rare diseases or conditions, administered by the Food and Drug Administration. Section 360bb provides for the designation of a drug as an orphan drug where it is intended for a rare disease or condition, generally one affecting fewer than 200,000 persons in the United States or for which there is no reasonable expectation of recovering development costs. Section 360cc provides the central incentive of marketing exclusivity: where the FDA approves an application or licenses an orphan-designated drug, it may not approve another application or license for the same drug for the same disease or condition for a period of seven years from approval, except where the holder cannot assure a sufficient quantity of the drug or consents to approval of another application, or where a subsequent applicant shows that its drug, though otherwise the same, is clinically superior by greater efficacy, greater safety, or a major contribution to patient care. Section 360aa provides for FDA recommendations on investigations, section 360dd for open protocols, and section 360ee for grants and contracts for the development of orphan products. The Act, together with orphan drug tax credits, is the legal foundation for US rare disease drug development incentives.
Pillar: Pharmaceuticals & Life Sciences · Authority: US Congress / Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.govinfo.gov/content/pkg/USCODE-2022-title21/html/USCODE-2022-title21-chap9.htm
SHA-256 integrity: 8fc18f2834856d69daca8376a574270e8744e297fd3f6872233738a68a3a1896
Primary Citations — 8 traced to source
- Orphan Drug Act, 21 U.S.C. 360aa - recommendations for investigations of drugs for rare diseases or conditions.
- Orphan Drug Act, 21 U.S.C. 360bb - designation of drugs for rare diseases or conditions.
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