Recent evidence points to an increased attention on women’s health issues at the FDA. During the FDA’s 2019 Science Forum held in September, Dr. Beverly-Lyn Cook of the National Center for Toxicological Research discussed sex and gender differences in health and disease with examples in kidney disease. Among other points, Dr. Cook called for an evaluation of normal kidney transporter and metabolic enzyme distribution and function to better understand clinical observations of increased number and severity of adverse events for women. CDRH has just published their Health of Women Strategic Plan, noting that research has been historically conducted predominantly in males, and that sex as a biological variable and gender as a clinical variable have great relevance in the analysis and interpretation of study data. This document is quite an interesting read, calling not for more data but the improved analysis and reporting of sex and gender-specific data, strengthening internal CDRH programs in women’s health, and development of a research roadmap for the women’s health device ecosystem. The appendices provide a nice review of our current understanding of sex and gender differences in health that is applicable to both drug and device development. I hope to see this emphasis applied to evaluations of medical products developed as a response to COVID-19.
Reach out to me if you want to know more or discuss your medical product development challenges.
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