New report aims to provide better understanding of the biology of sex differences

The Society for Women's Health Research, a Washington, D.C., based advocacy organization, has issued a report to aid the Food and Drug Administration's Critical Path Initiative in its efforts to advance research on sex and gender differences and enhance the contributions of that research to improve therapeutic product development.

The FDA established the Critical Path Initiative in 2004 to modernize the process by which scientific discoveries are transformed from the laboratory into medical practice. The Society for Women's Health Research and the FDA Office of Women's Health convened a workshop in November 2006 to determine the best approaches to utilize the Critical Path Initiative to explore biological differences between women and men, an important variable in therapeutic product safety and efficacy.

“A guiding principle of the FDA's Critical Path Initiative is to foster more collaborative efforts in drug development among government, academia, industry, and patient groups,” said Sherry Marts, Ph.D., vice president of scientific affairs for the Society, which released the report during National Women's Health Week. “This workshop was a perfect example of how members from each of those communities can work together to create recommendations that will further the FDA's efforts on sex and gender differences research.”

The report is the Society's second in a scientific series on understanding the biology of sex differences and advancing research.

“Advancing research into the biological basis of differences in the prevention, diagnosis, and treatment of disease in women and men is a significant part of the mission of the Society,” said Phyllis Greenberger, M.S.W., president and CEO of the Society. “We know that there are sex differences in the processes of drug absorption and metabolism, and in some areas of safety and efficacy, so we owe it to all patients to further explore these differences in current and future therapies.”

Kathleen Uhl, M.D., assistant commissioner for women's health at the FDA, notes in the report that “the FDA's Critical Path Opportunities List, although quite extensive, has nothing that is unique to women's health and nothing that is specific about sex and gender differences, hence the reason for the workshop.”

Workshop participants developed recommendations for the integration of analysis for sex differences research in the Critical Path Initiative. These recommendations encompass data collection and analysis, and research methodology.

Overall, the workshop participants concluded that the question of sex differences, including the analysis of outcomes by sex, must be considered at every step in the development of dugs, devices and biologics. Failure to consider sex differences during data collection and analysis will severely limit the usefulness of clinical data in the regulatory evaluation of product safety and efficacy. Greater knowledge and understanding of sex differences at the time of evaluation and marketing approval decisions will enable sponsors and the FDA to usher into the era of individualized medicine more efficiently, and will ultimately benefit all patients and consumers.