Content analysis of promotional materials for prescription drugs authorized under emergency use authorization

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.