Orphan Drug Act of 1983
E165703
The Orphan Drug Act of 1983 is a U.S. law that incentivizes the development of treatments for rare diseases by offering benefits such as market exclusivity, tax credits, and research grants to drug manufacturers.
All labels observed (1)
| Label | Occurrences |
|---|---|
| Orphan Drug Act of 1983 canonical | 1 |
How this entity was disambiguated
This entity first appeared as the object of triple T1445197 — resolving that mention is where its identity was fixed. The disambiguator weighed these candidate entities and picked the highlighted one (or “None”, minting a new entity). This is how homonymy is resolved: the same surface form can point to different entities.
NED1
Entity disambiguation (via context triple)
gpt-5-mini-2025-08-07
Target entity: Orphan Drug Act of 1983 Context triple: [Federal Food, Drug, and Cosmetic Act, amendedBy, Orphan Drug Act of 1983]
-
A.
National Cancer Act of 1971
The National Cancer Act of 1971 is a landmark U.S. law that greatly expanded federal funding and coordination for cancer research, prevention, and treatment, helping launch the modern "war on cancer."
-
B.
Anti-Drug Abuse Act of 1988
The Anti-Drug Abuse Act of 1988 is a U.S. federal law that expanded the war on drugs by increasing penalties, funding enforcement and treatment programs, and establishing a coordinated national drug control strategy.
-
C.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.
-
D.
National Cancer Institute Act of 1937
The National Cancer Institute Act of 1937 is a U.S. federal law that formally established the National Cancer Institute as the government’s principal agency for cancer research and control.
-
E.
Bayh–Dole Act
The Bayh–Dole Act is a landmark 1980 U.S. law that allows universities, small businesses, and other institutions to retain ownership of inventions developed with federal funding, spurring technology transfer and commercialization.
- F. None of above. chosen
- G. Unsure - the case is ambiguous/there is not enough information to decide.
NED2
Entity disambiguation (via description)
gpt-5-mini-2025-08-07
Target entity: Orphan Drug Act of 1983 Target entity description: The Orphan Drug Act of 1983 is a U.S. law that incentivizes the development of treatments for rare diseases by offering benefits such as market exclusivity, tax credits, and research grants to drug manufacturers.
-
A.
National Cancer Act of 1971
The National Cancer Act of 1971 is a landmark U.S. law that greatly expanded federal funding and coordination for cancer research, prevention, and treatment, helping launch the modern "war on cancer."
-
B.
Anti-Drug Abuse Act of 1988
The Anti-Drug Abuse Act of 1988 is a U.S. federal law that expanded the war on drugs by increasing penalties, funding enforcement and treatment programs, and establishing a coordinated national drug control strategy.
-
C.
Federal Food, Drug, and Cosmetic Act
The Federal Food, Drug, and Cosmetic Act is a key U.S. law that authorizes the Food and Drug Administration to regulate the safety, labeling, and marketing of food, drugs, medical devices, and cosmetics.
-
D.
National Cancer Institute Act of 1937
The National Cancer Institute Act of 1937 is a U.S. federal law that formally established the National Cancer Institute as the government’s principal agency for cancer research and control.
-
E.
Bayh–Dole Act
The Bayh–Dole Act is a landmark 1980 U.S. law that allows universities, small businesses, and other institutions to retain ownership of inventions developed with federal funding, spurring technology transfer and commercialization.
- F. None of above. chosen
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
United States federal law
ⓘ
health law ⓘ pharmaceutical regulation ⓘ |
| administeredBy |
Office of Orphan Products Development
ⓘ
Food and Drug Administration ⓘ
surface form:
U.S. Food and Drug Administration
|
| alsoKnownAs | ODA ⓘ |
| amendedBy |
Food and Drug Administration Modernization Act of 1997
ⓘ
surface form:
FDA Modernization Act of 1997
Food and Drug Administration Safety and Innovation Act of 2012 ⓘ |
| appliesTo |
biological products for rare diseases
ⓘ
drugs for rare diseases ⓘ |
| beneficiary |
biotechnology companies
ⓘ
drug manufacturers ⓘ patients with rare diseases ⓘ |
| codifiedIn | 21 U.S.C. § 360aa–360dd ⓘ |
| containsProvision |
exclusivity for the approved indication
ⓘ
grants for clinical testing of orphan drugs ⓘ protocol assistance for orphan drug development ⓘ |
| country |
United States of America
ⓘ
surface form:
United States
|
| criterion |
affects fewer than 200,000 people in the United States
ⓘ
no reasonable expectation of recovering development costs through U.S. sales ⓘ |
| dateSigned | 1983-01-04 ⓘ |
| defines |
orphan drug
ⓘ
rare disease or condition ⓘ |
| effect |
increased number of FDA-approved orphan drugs
ⓘ
increased number of orphan drug designations ⓘ |
| enactedBy | United States Congress ⓘ |
| establishes | orphan drug designation process ⓘ |
| inspired | orphan drug policies in other countries ⓘ |
| jurisdiction |
United States government
ⓘ
surface form:
United States federal government
|
| legalCitation | Public Law 97-414 ⓘ |
| marketExclusivityTerm | 7 years ⓘ |
| policyGoal |
to increase availability of treatments for rare diseases
ⓘ
to reduce financial risk of developing rare disease therapies ⓘ |
| primaryPurpose | to encourage development of drugs for rare diseases ⓘ |
| providesIncentive |
federal research grants
ⓘ
fee waivers or reductions ⓘ market exclusivity ⓘ tax credits for clinical testing ⓘ |
| relatedTo |
Regulation (EC) No 141/2000 on orphan medicinal products
ⓘ
surface form:
European Union orphan medicinal product regulation
|
| requires | FDA designation before approval to receive orphan incentives ⓘ |
| sector |
healthcare
ⓘ
pharmaceutical industry ⓘ |
| signedBy | Ronald Reagan ⓘ |
| subjectArea |
drug development incentives
ⓘ
pharmaceutical economics ⓘ rare diseases ⓘ |
| taxCreditRate | up to 50 percent of qualified clinical testing expenses (historically) ⓘ |
| yearEnacted | 1983 ⓘ |
How these facts were elicited
The pipeline generated the facts above by prompting gpt-5.1 with this entity's name + description and the instruction below.
Instruction
You are a knowledge base construction expert. Given a subject entity and a description of it, return factual statements that you know for the subject as a JSON list of dictionaries(triples), where keys must be "subject", "predicate" and "object". The number of facts may be very high, between 25 to 50 or more, for very popular subjects. For less popular subjects, the number of facts can be very low, like 5 or 10. # Requirements - If you don't know the subject at all, return an empty list. - If the subject is not a named entity, return an empty list. - Include at least one triple where predicate is "instanceOf". - Do not get too wordy. - Separate several objects into multiple triples with one object.
Input
Subject: Orphan Drug Act of 1983 Description of subject: The Orphan Drug Act of 1983 is a U.S. law that incentivizes the development of treatments for rare diseases by offering benefits such as market exclusivity, tax credits, and research grants to drug manufacturers.
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.