Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU

Mulinari, Shai; Vilhelmsson, Andreas; Ozierański, Piotr; Bredström, Anna

doi:10.1016/j.socscimed.2021.114049

Cited by 10 publications

(16 citation statements)

References 32 publications

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“…On the other hand, a previous study found that racialised pharmaceutical regulation is happening in the EU too (Mulinari et al 2021). While the EMA never approved BiDil, nor any other drug for specific races or ethnicities, the EMA sometimes alerts prescribers to racial or ethnic differences in drug response-in fact, it does so more often than the FDA (Mulinari et al 2021). Furthermore, as in the USA, racialised pharmaceutical regulation in the EU is underpinned by a distinctively biological race concept in apparent contradiction to its dismissal in the GDPR and in much scientific and political discourse in Europe (M'charek et al 2014).…”

Section: The Enduring Presence Of Race In Pharmaceutical Regulationmentioning

confidence: 92%

“…The GDPR apparently does not approve of it, and, as mentioned, there is a consensual "ban" on the use of the race concept in many European countries (Simon 2012). On the other hand, a previous study found that racialised pharmaceutical regulation is happening in the EU too (Mulinari et al 2021). While the EMA never approved BiDil, nor any other drug for specific races or ethnicities, the EMA sometimes alerts prescribers to racial or ethnic differences in drug response-in fact, it does so more often than the FDA (Mulinari et al 2021).…”

Section: The Enduring Presence Of Race In Pharmaceutical Regulationmentioning

confidence: 98%

“…BiDil's approval was accused of reinforcing US census categories and biologised conceptualisations among scientists and prescribers, in this way normalising ideas that race and ethnicity are integral to the proper pharmaceutical management of patients (Kahn 2012). Although no other drug has been approved for a specific race or ethnicity by the FDA, there have been several other examples of racialised pharmaceutical regulation since BiDil, demonstrating commitment to a biological race concept in the USA (Mulinari et al 2021).…”

Section: The Enduring Presence Of Race In Pharmaceutical Regulationmentioning

confidence: 99%

“…Furthermore, some US scholarship suggests that a central actor promoting the use of race and ethnicity in medicine and beyond is the Food and Drug Administration (FDA) (Epstein 2007;Kahn 2012;Pollock 2012;Inda 2016;Fisher 2020). The FDA has major "conceptual power" over medical research, policy, and practice (Carpenter 2014, p. 64), and, in the case of race and ethnicity, this conceptual power is seen when the FDA requires or encourages race-and ethnicity-based data collection and analysis in clinical trials using a set of established definitions and categories, when it participates in interpreting the results of these analyses, and when it promotes the dissemination of "difference findings" pertaining to racial and ethnic groups (Mulinari et al 2021).…”

Section: Introductionmentioning

confidence: 99%

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“Black race”, “Schwarze Hautfarbe”, “Origine africaine”, or “Etnia nera”? The absent presence of race in European pharmaceutical regulation

Mulinari

Bredström

2022

BioSocieties

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Current scholarship on race in Europe has described race as an “absent presence”. However, little is known about the dynamics of the absentness and presentness of race, including how various social processes operating at distinct levels (e.g. supranational and national) influence the uses of race and ethnicity concepts. We begin addressing this gap by examining racialised pharmaceutical regulation in the EU and its operationalisation in European countries. We analysed patterns of English-language uses of race and ethnicity terms at the EU level for all new drugs approved in 2014–2018, and systematically compared official translations into 24 languages. We found that “race” was promoted in plain sight and often retained when translated, albeit with much inconsistency across languages, creating peculiar patterns of presentness and absentness of race. Finnish, French, Swedish, and German stood out, as “race” was often translated into ethnicity terms, but even in those languages, “race” lingered despite claims that these countries vehemently opposed “race”. Our findings should inform scholarly and political debates about race, ethnicity, and medicine in Europe that tend to assume, incorrectly, an anti-racialist consensus. There are also policy implications, because prescribers may interpret regulator-approved information about race and ethnicity differently because of inconsistent translations.

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Section: The Enduring Presence Of Race In Pharmaceutical Regulationmentioning

confidence: 92%

Section: The Enduring Presence Of Race In Pharmaceutical Regulationmentioning

confidence: 98%

Section: The Enduring Presence Of Race In Pharmaceutical Regulationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

“Black race”, “Schwarze Hautfarbe”, “Origine africaine”, or “Etnia nera”? The absent presence of race in European pharmaceutical regulation

Mulinari

Bredström

2022

BioSocieties

Self Cite

View full text Add to dashboard Cite

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“…Moreover, US regulatory standards are disseminated in other parts of the world thanks to the harmonization of drug testing and regulation. For example, more EU than US pharmaceutical product labels contain statements about racial and ethnic differences and there is evidence that reporting of ethnoracial demographics in the labels of all novel drugs in the EU may be driven, at least in part, by statements on US labels (Mulinari et al, 2021). Researchers all over the world are thus constantly encouraged to look for information to corroborate hypotheses about the relation between races/ethnicities and disease or treatment options.…”

Section: Conclusion: Towards An Ethics Of Categorization For Medical ...mentioning

confidence: 99%

Reductionist methodology and the ambiguity of the categories of race and ethnicity in biomedical research: an exploratory study of recent evidence

Żuradzki

2022

Med Health Care and Philos

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In this article, we analyse how researchers use the categories of race and ethnicity with reference to genetics and genomics. We show that there is still considerable conceptual “messiness” (despite the wide-ranging and popular debate on the subject) when it comes to the use of ethnoracial categories in genetics and genomics that among other things makes it difficult to properly compare and interpret research using ethnoracial categories, as well as draw conclusions from them. Finally, we briefly reconstruct some of the biases of reductionism to which geneticists (as well as other researchers referring to genetic methods and explanations) are particularly exposed to, and we analyse the problem in the context of the biologization of ethnoracial categories. Our work constitutes a novel, in-depth contribution to the debate about reporting race and ethnicity in biomedical and health research. First, we reconstruct the theoretical background assumptions about racial ontology which researchers implicitly presume in their studies with the aid of a sample of recent papers published in medical journals about COVID-19. Secondly, we use the typology of the biases of reductionism to the problem of biologization of ethnoracial categories with reference to genetics and genomics.

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Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives: White Paper

Sawant‐Basak,

Urva,

Mukker

et al. 2024

Clin Pharma and Therapeutics

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The 2022 United States Food and Drug Administration (US FDA) draft guidance on diversity plan (DP), which will be implemented through the Diversity Action Plans by December 2025, under the 21st Century Cures Act, marks a pivotal effort by the FDA to ensure that registrational studies adequately reflect the target patient populations based on diversity in demographics and baseline characteristics. This white paper represents the culminated efforts of the International Consortium of Quality and Innovation (IQ) Diversity and Inclusion (D&I) Working Group (WG) to assess the implementation of the draft FDA guidance by members of the IQ consortium in the discipline of clinical pharmacology (CP). This article describes current practices in the industry and emphasizes the tools and techniques of quantitative pharmacology that can be applied to support the inclusion of a diverse population during global drug development, to support diversity and inclusion of underrepresented patient populations, in multiregional clinical trials (MRCTs). It outlines strategic and technical recommendations to integrate demographics, including age, sex/gender, race/ethnicity, and comorbidities, in multiregional phase III registrational studies, through the application of quantitative pharmacology. Finally, this article discusses the challenges faced during global drug development, which may otherwise limit the enrollment of a broader, potentially diverse population in registrational trials. Based on the outcomes of the IQ survey that provided the current awareness of diversity planning, it is envisioned that in the future, industry efforts in the inclusion of previously underrepresented populations during global drug development will culminate in drug labels that apply to the intended patient populations at the time of new drug application or biologics license application rather than through post‐marketing requirements.

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Is there evidence for the racialization of pharmaceutical regulation? Systematic comparison of new drugs approved over five years in the USA and the EU

Cited by 10 publications

References 32 publications

“Black race”, “Schwarze Hautfarbe”, “Origine africaine”, or “Etnia nera”? The absent presence of race in European pharmaceutical regulation

“Black race”, “Schwarze Hautfarbe”, “Origine africaine”, or “Etnia nera”? The absent presence of race in European pharmaceutical regulation

Reductionist methodology and the ambiguity of the categories of race and ethnicity in biomedical research: an exploratory study of recent evidence

Role of Clinical Pharmacology in Diversity and Inclusion in Global Drug Development: Current Practices and Industry Perspectives: White Paper

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