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Regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny
The Swedish Medical Products Agency (MPA) objects to the fact that we occasionally refer to one of its senior ex-employees by name. However, names of individual MPA assessors, Food and Drug Administration (FDA) reviewers, and European Medicines Agency rapporteurs and co-rapporteurs are cited in regu...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6237023/ https://www.ncbi.nlm.nih.gov/pubmed/30428900 http://dx.doi.org/10.1186/s12961-018-0371-4 |
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author | Mulinari, Shai Davis, Courtney |
author_facet | Mulinari, Shai Davis, Courtney |
author_sort | Mulinari, Shai |
collection | PubMed |
description | The Swedish Medical Products Agency (MPA) objects to the fact that we occasionally refer to one of its senior ex-employees by name. However, names of individual MPA assessors, Food and Drug Administration (FDA) reviewers, and European Medicines Agency rapporteurs and co-rapporteurs are cited in regulatory documents and are a matter of public record. In our paper (Health Res Policy Syst 15:93, 2017), we in no way suggest that regulatory decisions were left to individual reviewers or assessors, although we do emphasise that individual MPA and FDA employees’ scientific assessments and benefit–risk evaluations are critical to the decision-making process. In this response to the MPA, we raise a further issue – one in which the question of personal identification of individuals is relevant – and this pertains to the accountability of influential scientists and experts who contribute to public policy decisions with important ramifications for public health. In our view, it is important that interested observers are able to identify those influential individuals, and entirely appropriate that their work should be open to public scrutiny. |
format | Online Article Text |
id | pubmed-6237023 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-62370232018-11-23 Regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny Mulinari, Shai Davis, Courtney Health Res Policy Syst Letter to the Editor The Swedish Medical Products Agency (MPA) objects to the fact that we occasionally refer to one of its senior ex-employees by name. However, names of individual MPA assessors, Food and Drug Administration (FDA) reviewers, and European Medicines Agency rapporteurs and co-rapporteurs are cited in regulatory documents and are a matter of public record. In our paper (Health Res Policy Syst 15:93, 2017), we in no way suggest that regulatory decisions were left to individual reviewers or assessors, although we do emphasise that individual MPA and FDA employees’ scientific assessments and benefit–risk evaluations are critical to the decision-making process. In this response to the MPA, we raise a further issue – one in which the question of personal identification of individuals is relevant – and this pertains to the accountability of influential scientists and experts who contribute to public policy decisions with important ramifications for public health. In our view, it is important that interested observers are able to identify those influential individuals, and entirely appropriate that their work should be open to public scrutiny. BioMed Central 2018-11-15 /pmc/articles/PMC6237023/ /pubmed/30428900 http://dx.doi.org/10.1186/s12961-018-0371-4 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Letter to the Editor Mulinari, Shai Davis, Courtney Regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny |
title | Regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny |
title_full | Regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny |
title_fullStr | Regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny |
title_full_unstemmed | Regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny |
title_short | Regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny |
title_sort | regulatory scientists’ work has important ramifications for public health and should be open to public scrutiny |
topic | Letter to the Editor |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6237023/ https://www.ncbi.nlm.nih.gov/pubmed/30428900 http://dx.doi.org/10.1186/s12961-018-0371-4 |
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