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

Women, Minorities and the Elderly Should Be Informed When They Are Using Something that Has Not Been Sufficiently Tested on Them

Released: 1-Apr-2014 9:30 AM EDT
Source Newsroom: Society for Women's Health Research (SWHR)
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Newswise — Society for Women’s Health Research (SWHR®) President and CEO Phyllis Greenberger will urge the U.S. Food and Drug Administration (FDA) to increase the participation of women and minorities in clinical trials along with greater reporting and analysis of sex differences during a hearing today at the FDA headquarters near Washington, D.C.

Greenberger will offer a number 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. Key recommendations include but are not limited to:

• Demographic data should be standardized, collected, analyzed and reported publicly
• Women, minorities and the elderly should be included in all phases of clinical research proportional to the disease in the population
• Labels should inform these populations when they are using drugs or devices that have not been sufficiently tested on them, or list the populations the product has been tested on
• Disease-specific registries should be established to encourage those affected to sign up for medical studies and include incentives to keep them engaged in the research process
• All reviewers should be immediately trained in the need to examine the appropriate demographic data with ongoing review and re-training at regular intervals
• Drug and device applications that include the appropriate subpopulation representation should be put on a fast track for approval while applications that do not should be rejected, because post market surveillance should not substitute for what should be discovered in the premarket approval process

“For nearly 25 years, the Society for Women’s Health Research 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,” says Greenberger. “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.”

SWHR® is the leading voice on research into the biological sex differences between women and men. Find out more about SWHR’s public policy advocacy at SWHR.org.


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