Department of Sociology, Faculty of Social Sciences, Lund University, Sweden.
Division of Social Medicine and Global Health, Department of Clinical Sciences Malmö, Lund University, Malmö, Sweden.
Soc Sci Med. 2021 Jul;280:114049. doi: 10.1016/j.socscimed.2021.114049. Epub 2021 May 20.
Recent decades have seen much interest in racial and ethnic differences in drug response. The most emblematic example is the heart drug BiDil, approved by the US Food and Drug Administration in 2005 for "self-identified blacks." Previous social science research has explored this "racialization of pharmaceutical regulation" in the USA, and discussed its implications for the "pharmaceuticalization of race" in terms of reinforcing certain taxonomic schemes and conceptualizations. Yet, little is known about the racialization of pharmaceutical regulation in the USA after BiDil, and how it compares with the situation in the EU, where political and regulatory commitment to race and ethnicity in pharmaceutical medicine is weak. We have addressed these gaps by investigating 397 product labels of all novel drugs approved in the USA (n = 213) and the EU (n = 184) between 2014 and 2018. Our analysis considered statements in labeling and the racial/ethnic categories used. Overall, it revealed that many labels report race/ethnicity demographics and subgroup analyses, but that there are important differences between the USA and the EU. Significantly more US labels specified race/ethnicity demographics, as expected given the USA's greater commitment to race and ethnicity in pharmaceutical medicine. Moreover, we found evidence that reporting of race/ethnicity demographics in EU labels was driven, in part, by statements in US labels, suggesting the spillover of US regulatory standards to the EU. Unexpectedly, significantly more EU labels reported differences in drug response, although no drug was restricted to a racial/ethnic population in a manner similar to BiDil. Our analysis also noted variability and inconsistency in the racial/ethnic taxonomy used in labels. We discuss implications for the racialization of pharmaceutical regulation and the pharmaceuticalization of race in the USA and EU.
近几十年来，人们对药物反应中的种族和民族差异产生了浓厚的兴趣。最具代表性的例子是心脏药物 BiDil，该药物于 2005 年被美国食品和药物管理局批准用于“自我认定的黑人”。先前的社会科学研究探讨了美国的这种“药物监管的种族化”现象，并讨论了其对“种族的药物化”的影响，即强化了某些分类方案和概念化。然而，人们对 BiDil 之后美国药物监管的种族化知之甚少，也不知道它与欧盟的情况相比如何，因为欧盟在药物医学中的种族和民族问题上的政治和监管承诺较弱。为了填补这些空白，我们调查了 2014 年至 2018 年间在美国（n=213）和欧盟（n=184）批准的所有新药的 397 个产品标签。我们的分析考虑了标签中的陈述和所使用的种族/民族类别。总体而言，研究结果表明，许多标签报告了种族/民族人口统计数据和亚组分析，但美国和欧盟之间存在重要差异。与美国在药物医学中对种族和民族的更大承诺相符，更多的美国标签指定了种族/民族人口统计数据。此外，我们发现证据表明，欧盟标签中报告种族/民族人口统计数据的部分原因是美国标签中的陈述，这表明美国监管标准向欧盟的溢出。出乎意料的是，更多的欧盟标签报告了药物反应的差异，尽管没有一种药物像 BiDil 那样将药物限制在特定的种族/民族群体中。我们的分析还注意到标签中使用的种族/民族分类法的可变性和不一致性。我们讨论了美国和欧盟药物监管种族化和种族药物化的影响。
