Public Law 97-414
E642118
Public Law 97-414 is the U.S. federal statute commonly known as the Orphan Drug Act of 1983, which incentivizes the development of treatments for rare diseases through benefits such as market exclusivity and tax credits.
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
Orphan Drug Act
ⓘ
United States federal statute ⓘ |
| administeredBy |
Office of Orphan Products Development
NERFINISHED
ⓘ
U.S. Food and Drug Administration NERFINISHED ⓘ |
| alsoKnownAs | Orphan Drug Act of 1983 NERFINISHED ⓘ |
| amends | Federal Food, Drug, and Cosmetic Act NERFINISHED ⓘ |
| appliesTo |
biological products for rare diseases
ⓘ
drugs for rare diseases ⓘ |
| beneficiary |
drug sponsors developing orphan drugs
ⓘ
patients with rare diseases ⓘ |
| congressNumber | 97th United States Congress NERFINISHED ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| dateSigned | 1983-01-04 ⓘ |
| definesTerm |
orphan drug
ⓘ
rare disease ⓘ |
| effect |
financial incentives for sponsors of orphan drugs
ⓘ
increased number of approved orphan drugs ⓘ |
| eligibilityCriterion |
disease affecting fewer than 200,000 persons in the United States
ⓘ
no reasonable expectation of recovering development costs from U.S. sales ⓘ |
| enactedBy | United States Congress ⓘ |
| establishes | orphan drug designation process ⓘ |
| hasComponent |
orphan drug market exclusivity provision
ⓘ
orphan drug tax credit ⓘ orphan product grants program ⓘ |
| historicalContext | early 1980s concern about lack of treatments for rare diseases ⓘ |
| inForce | true ⓘ |
| legalCitation | 96 Stat. 2049 ⓘ |
| marketExclusivityDuration | 7 years ⓘ |
| officeOfSigner | President of the United States NERFINISHED ⓘ |
| policyArea |
health law
ⓘ
pharmaceutical regulation ⓘ rare disease policy ⓘ |
| primaryPurpose |
to encourage development of drugs for rare diseases
ⓘ
to provide incentives for orphan drug development ⓘ |
| providesIncentive |
grant funding for clinical research
ⓘ
market exclusivity ⓘ tax credits for clinical testing ⓘ waiver or reduction of FDA user fees ⓘ |
| publicLawNumber | 97-414 ⓘ |
| regulatoryBody |
Center for Biologics Evaluation and Research
NERFINISHED
ⓘ
Center for Drug Evaluation and Research NERFINISHED ⓘ |
| sectorImpacted |
biotechnology industry
ⓘ
pharmaceutical industry ⓘ |
| shortName | Orphan Drug Act NERFINISHED ⓘ |
| signedBy | Ronald Reagan ⓘ |
| title | An Act to amend the Federal Food, Drug, and Cosmetic Act to facilitate the development of drugs for rare diseases and conditions, and for other purposes ⓘ |
| yearEnacted | 1983 ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.