Drug Price Competition and Patent Term Restoration Act
GPTKB entity
Statements (56)
| Predicate | Object |
|---|---|
| gptkbp:instance_of |
gptkb:United_States_federal_law
|
| gptkbp:affects |
brand-name drugs
|
| gptkbp:aims_to |
facilitate generic drug approval
|
| gptkbp:amends |
gptkb:Federal_Food,_Drug,_and_Cosmetic_Act
|
| gptkbp:date_enacted |
gptkb:1984
|
| gptkbp:enacted_by |
gptkb:United_States_Congress
|
| gptkbp:encourages |
competition in drug market
|
| gptkbp:establishes |
Abbreviated New Drug Application (ANDA) process
|
| gptkbp:has_facilitated |
entry of generics into the market
|
| gptkbp:has_implications_for |
drug affordability
|
| gptkbp:has_led_to |
increase in generic drug market share
|
| https://www.w3.org/2000/01/rdf-schema#label |
Drug Price Competition and Patent Term Restoration Act
|
| gptkbp:impact |
gptkb:pharmaceuticals
|
| gptkbp:influences |
drug pricing
|
| gptkbp:is_analyzed_in |
its effects on healthcare costs
pharmaceutical economics research |
| gptkbp:is_associated_with |
market exclusivity periods
|
| gptkbp:is_cited_in |
court cases regarding drug patents
policy proposals for drug pricing reform |
| gptkbp:is_considered |
landmark legislation
a model for other countries a significant reform in drug policy. |
| gptkbp:is_criticized_for |
potential impact on innovation
|
| gptkbp:is_discussed_in |
congressional hearings
legal and economic studies academic journals on health policy |
| gptkbp:is_evaluated_by |
economic impact assessments
health policy analysts pharmaceutical industry experts |
| gptkbp:is_examined_in |
law school curricula
|
| gptkbp:is_implemented_in |
gptkb:Food_and_Drug_Administration_(FDA)
|
| gptkbp:is_influenced_by |
lobbying from pharmaceutical companies
|
| gptkbp:is_linked_to |
drug safety regulations
drug approval timelines generic drug litigation |
| gptkbp:is_opposed_by |
some brand-name manufacturers
|
| gptkbp:is_part_of |
U. S. healthcare policy
U. S. drug regulation history U. S. patent law framework the Hatch-Waxman framework |
| gptkbp:is_referenced_in |
healthcare policy debates
drug patent disputes |
| gptkbp:is_related_to |
intellectual property law
|
| gptkbp:is_subject_to |
judicial interpretation
ongoing legislative review |
| gptkbp:is_supported_by |
consumer advocacy groups
|
| gptkbp:promotes |
availability of lower-cost medications
|
| gptkbp:provides |
patent term restoration
|
| gptkbp:related_to |
gptkb:Hatch-Waxman_Act
|
| gptkbp:requires |
FDA approval for generics
|
| gptkbp:signed_by |
gptkb:Sir_Ronald_Reagan
|
| gptkbp:supports |
public health initiatives
|
| gptkbp:bfsParent |
gptkb:Hatch-Waxman_Act
gptkb:Food_and_Drug_Administration_Reauthorization_Act gptkb:Federal_Food,_Drug,_and_Cosmetic_Act_of_1938 |
| gptkbp:bfsLayer |
6
|