Content Analysis of Promotional Materials for Prescription Drugs Authorized Under Emergency Use Authorization.

IF 3.8 2区医学 Q1 PHARMACOLOGY & PHARMACY

Drug Safety Pub Date : 2025-09-25 DOI:10.1007/s40264-025-01610-0

Bridget Kelly, Kathryn J Aikin, Helen W Sullivan, Gabe Madson, Anne-Celine Jeffroy-Menard, Diamond Hawkins, Kathy Vu, Shirley Liu, Lauren McCormack, Sandra Crouse Quinn

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Abstract

Introduction: Under Section 564 of the Federal Food, Drug and Cosmetic Act, the United States (US) Food and Drug Administration (FDA) may, pursuant to a declaration by the US Department of Health and Human Services Secretary, based on one of four types of determinations, authorize an unapproved product or unapproved uses of an approved product for emergency use. Although sponsors are not prohibited from promoting products with Emergency Use Authorizations (EUAs), little is known about how they promote these products.

Objectives: The aim of this study was to investigate how EUAs are being described in promotional materials disseminated to health care providers (HCPs) and consumer audiences.

Methods: A content analysis was conducted on promotional materials for drugs authorized under an EUA that were submitted to the FDA between April 2020 and April 2023. Each material was coded for the presence or absence and location of certain words, phrases, or resources relating to EUAs and product risk information. Statistical analyses include descriptive statistics and bivariate analyses comparing materials created for consumer and HCP audiences. Readability statistics were also conducted for consumer materials.

Results: The sample included 423 promotional materials. Most materials included risk information; however, few included a formal definition of an EUA. Materials for HCPs were more likely to contain links to fact sheets and other information and resources related to EUAs. The reading level of consumer materials was very difficult (requiring graduate-level education).

Conclusion: Although most of the materials contained risk and benefit information in promotional materials about EUAs, improvements could be made through the inclusion of a specific definition of "EUA" and more prominent information about limitations of use in consumer materials. Readability could also be improved for consumer materials by applying plain language principles.

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紧急使用授权处方药宣传资料内容分析

导言：根据《联邦食品、药品和化妆品法》第564条，美国食品和药物管理局（FDA）可以根据美国卫生和公众服务部部长的声明，基于四种类型的决定之一，授权未经批准的产品或未经批准的紧急用途。虽然赞助商不被禁止推广具有紧急使用授权（EUAs）的产品，但人们对他们如何推广这些产品知之甚少。目的：本研究的目的是调查eua是如何在传播给卫生保健提供者（HCPs）和消费者受众的宣传材料中描述的。方法：对2020年4月至2023年4月期间提交给FDA的EUA授权药品的宣传材料进行内容分析。每个材料都被编码为与eua和产品风险信息相关的某些单词、短语或资源的存在或不存在和位置。统计分析包括描述性统计和双变量分析，比较为消费者和HCP受众创建的材料。对消费材料也进行了可读性统计。结果：样本包括423份宣传资料。大多数材料包括风险信息；然而，其中很少包括EUA的正式定义。卫生保健提供者的材料更有可能包含与eua有关的情况说明书和其他信息和资源的链接。消费材料的阅读水平非常困难（需要研究生水平的教育）。结论：虽然大多数材料在EUA的宣传材料中包含风险和利益信息，但可以通过包含“EUA”的具体定义和更突出的消费材料使用限制信息来改进。通过应用通俗易懂的语言原则，也可以提高消费者材料的可读性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Drug Safety 医学-毒理学

CiteScore

7.60

自引率

7.10%

发文量

112

审稿时长

6-12 weeks

期刊介绍： Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.