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Review
. 2023 Feb 8;20(4):2962.
doi: 10.3390/ijerph20042962.

Sex, Gender, and the Regulation of Prescription Drugs: Omissions and Opportunities

Lorraine Greaves  1   2 , Andreea C Brabete  1 , Mira Maximos  1   3   4 , Ella Huber  1 , Alice Li  1 , Mê-Linh Lê  5 , Sherif Eltonsy  6 , Madeline Boscoe  7   8
Affiliations
Review

Sex, Gender, and the Regulation of Prescription Drugs: Omissions and Opportunities

Lorraine Greaves et al. Int J Environ Res Public Health. .

Abstract

The regulation of prescription drugs is an important health, safety, and equity issue. However, regulatory processes do not always consider evidence on sex, gender, and factors such as age and race, omissions that advocates have highlighted for several decades. Assessing the impact of sex-related factors is critical to ensuring drug safety and efficacy for females and males, and for informing clinical product monographs and consumer information. Gender-related factors affect prescribing, access to drugs, needs and desires for specific prescribed therapies. This article draws on a policy-research partnership project that examined the lifecycle management of prescription drugs in Canada using a sex and gender-based analysis plus (SGBA+) lens. In the same time period, Health Canada created a Scientific Advisory Committee on Health Products for Women, in part to examine drug regulation. We report on grey literature and selected regulatory documents to illustrate the extent to which sex and gender-based analysis plus (SGBA+) is utilized in regulation and policy. We identify omissions in the management of prescription drugs, and name opportunities for improvements by integrating SGBA+ into drug sponsor applications, clinical trials development, and pharmacovigilance. We report on recent efforts to incorporate sex disaggregated data and recommend ways that the management of prescription drugs can benefit from more integration of sex, gender, and equity.

Keywords: EMA; FDA; Health Canada; ICH; SGBA+; equity; gender; pharmacovigilance; regulation of prescription drugs; sex.

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Conflict of interest statement

LG is the Chair, and SE and MB are Members of, the SAC-HPW as well as members of the research team. The structure of the funding program specifically brought together Health Canada employees and independent researchers to discuss data sources and structural aspects of the overall project. However, the interpretation of all data, conclusions and opinions expressed in this article are those of the authors alone, and in no way reflect the views of Health Canada. The funders had no role in the design of the study; in the analyses or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.

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