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

Lorraine Greaves (), Andreea C. Brabete, Mira Maximos, Ella Huber, Alice Li, Mê-Linh Lê, Sherif Eltonsy and Madeline Boscoe
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Lorraine Greaves: Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada
Andreea C. Brabete: Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada
Mira Maximos: Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada
Ella Huber: Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada
Alice Li: Centre of Excellence for Women’s Health, Vancouver, BC V6H 3N1, Canada
Mê-Linh Lê: Neil John Maclean Health Sciences Library, University of Manitoba, Winnipeg, MB R3M 3M1, Canada
Sherif Eltonsy: College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB R3M 3M1, Canada
Madeline Boscoe: Cochrane Sex/Gender Methods Group, Ottawa, ON K0A K4C, Canada

IJERPH, 2023, vol. 20, issue 4, 1-19

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: sex; gender; equity; SGBA+; regulation of prescription drugs; pharmacovigilance; ICH; FDA; EMA; Health Canada (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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