Public sector financial support for late stage discovery of new drugs in the United States: cohort study.
BMJ
; 367: l5766, 2019 10 23.
Article
em En
| MEDLINE
| ID: mdl-31645328
ABSTRACT
OBJECTIVE:
To determine the extent to which late stage development of new drugs relies on support from public funding.DESIGN:
Cohort study.SETTING:
All new drugs containing one or more new molecular entities approved by the US Food and Drug Administration (FDA) between January 2008 and December 2017 via the new drug application pathway. MAIN OUTCOMEMEASURES:
Patents or drug development histories documenting late stage research contributions by a public sector research institution or a spin-off company, as well as each drug's regulatory approval pathway and first-in-class designation.RESULTS:
Over the 10 year study period, the FDA approved 248 drugs containing one or more new molecular entities. Of these drugs, 48 (19%) had origins in publicly supported research and development and 14 (6%) originated in companies spun off from a publicly supported research program. Drugs in these groups were more likely to receive expedited FDA approval (68% v 47%, P=0.005) or be designated first in class (45% v 26%, P=0.007), indicating therapeutic importance.CONCLUSIONS:
A review of the patents associated with new drugs approved over the past decade indicates that publicly supported research had a major role in the late stage development of at least one in four new drugs, either through direct funding of late stage research or through spin-off companies created from public sector research institutions. These findings could have implications for policy makers in determining fair prices and revenue flows for these products.
Texto completo:
1
Coleções:
01-internacional
Temas:
Fomentar_producao_conhecimento_especifico
Contexto em Saúde:
1_ASSA2030
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos como Assunto
/
Setor Público
/
Aprovação de Drogas
/
Pesquisa Translacional Biomédica
Tipo de estudo:
Etiology_studies
/
Health_economic_evaluation
/
Incidence_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
BMJ
Ano de publicação:
2019
Tipo de documento:
Article