Major Changes Needed for How the FDA Approves Medical Products, says Society for Women’s Health Research

According to the Society for Women's Health Research (SWHR), women, minorities and the elderly should be informed when they are using something that has not been sufficiently tested on them. On April 1, 2014, during a hearing at the Food and Drug Administration (FDA) headquarters near Washington, D.C., SWHR President and CEO, Phyllis Greenberger, urged the FDA to increase the participation of women and minorities in clinical trials along with greater reporting and analysis of sex differences.

During her testimony, Greenberger offered a list of recommendations for the FDA to change the way the agency handles the collection, analysis and availability of demographic subgroup data, including sex, race/ethnicity and age, in applications for approval of FDA regulated medical products. She commented that, "For nearly 25 years, the SWHR has advocated for the need for demographic subgroup reporting and analysis. We know this information is critical to help scientists to understand sex differences, and to patients and health care providers to make informed medical treatment decisions" She concluded by saying that, "Sex is the most basic variable of research and the entire field of personalized medicine needs to begin with this simple distinction. The FDA and other federal agencies can help make that possible"

For more information about SWHR advocacy visit www.SWHR.org

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