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Capture and passive predation in times of COVID-19 pandemic
In the midst of a health crisis, a drug in development and candidate for COVID-19 contagious disease was granted orphan-drug designation (ODD). This decision by the US Food and Drug Administration was immediately denounced as an abuse of the Orphan Drug Act (ODA). This paper outlines how this decisi...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer US
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9547627/ https://www.ncbi.nlm.nih.gov/pubmed/36248699 http://dx.doi.org/10.1007/s11127-022-01005-0 |
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author | Guennif, Samira |
author_facet | Guennif, Samira |
author_sort | Guennif, Samira |
collection | PubMed |
description | In the midst of a health crisis, a drug in development and candidate for COVID-19 contagious disease was granted orphan-drug designation (ODD). This decision by the US Food and Drug Administration was immediately denounced as an abuse of the Orphan Drug Act (ODA). This paper outlines how this decision may be considered as the result of a complex case of capture along the regulatory process. Therefore, a case study of the remdesivir episode is conducted, combining the definition of a framework for the analysis of capture and the identification of stylized facts marking the trajectory of a repositioned drug and candidate for COVID-19. In doing so, arguments are put forward to show to what extent this granting of ODD can be described as the result of a series of captures, a case of weak capture however that calls for an amendment of the ODA to preclude drugs for contagious and communicable epidemic diseases from obtaining orphan status in the first place. |
format | Online Article Text |
id | pubmed-9547627 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
spelling | pubmed-95476272022-10-11 Capture and passive predation in times of COVID-19 pandemic Guennif, Samira Public Choice Article In the midst of a health crisis, a drug in development and candidate for COVID-19 contagious disease was granted orphan-drug designation (ODD). This decision by the US Food and Drug Administration was immediately denounced as an abuse of the Orphan Drug Act (ODA). This paper outlines how this decision may be considered as the result of a complex case of capture along the regulatory process. Therefore, a case study of the remdesivir episode is conducted, combining the definition of a framework for the analysis of capture and the identification of stylized facts marking the trajectory of a repositioned drug and candidate for COVID-19. In doing so, arguments are put forward to show to what extent this granting of ODD can be described as the result of a series of captures, a case of weak capture however that calls for an amendment of the ODA to preclude drugs for contagious and communicable epidemic diseases from obtaining orphan status in the first place. Springer US 2022-10-08 2022 /pmc/articles/PMC9547627/ /pubmed/36248699 http://dx.doi.org/10.1007/s11127-022-01005-0 Text en © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2022, Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic. |
spellingShingle | Article Guennif, Samira Capture and passive predation in times of COVID-19 pandemic |
title | Capture and passive predation in times of COVID-19 pandemic |
title_full | Capture and passive predation in times of COVID-19 pandemic |
title_fullStr | Capture and passive predation in times of COVID-19 pandemic |
title_full_unstemmed | Capture and passive predation in times of COVID-19 pandemic |
title_short | Capture and passive predation in times of COVID-19 pandemic |
title_sort | capture and passive predation in times of covid-19 pandemic |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9547627/ https://www.ncbi.nlm.nih.gov/pubmed/36248699 http://dx.doi.org/10.1007/s11127-022-01005-0 |
work_keys_str_mv | AT guennifsamira captureandpassivepredationintimesofcovid19pandemic |