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For Immediate Release |
Contact: Amy Hoskins : 202-496-5015 |
Washington, D.C. — The health status of women has improved over the last several decades, but more work needs to be done to overcome long standing challenges such as lingering disparities in care and in outcomes, Food and Drug Administration Commissioner Mark B. McClellan said today at the annual Corporate Advisory Council meeting of the Society for Women’s Health Research (SWHR).
McClellan outlined several key areas of focus for improving women’s health, including the need to better understand gender differences in the way people respond to drugs and the need to make use of better data and better science to improve health outcomes for men and women alike.
“We now know that gender is one of the important factors that influences and predicts response to all kinds of treatments,” McClellan said. “In addition to defining risks and benefits unique to women, the FDA is working to better define the genetic differences between men and women that influence how they are going to respond to a particular medication.”
“We are developing a new demographic information and data repository that will have the capacity to track and encourage the inclusion of women in clinical studies as well as to provide more gender specific analysis to support drug-labeling information,” he said.
The FDA will release on Monday a draft copy of a new guidance policy designed to encourage product developers to submit pharmocogenomic data as part of their clinical trials, McClellan said.
“Pharmacogenomics aims to shed some scientific light on the gender differences that we all appreciate as part of routine medical practice, but don’t yet entirely understand,” McClellan said. Pharmacogenomics deals with the small genetic differences that help define why people respond differently to the same drug, or have different risks or side effects.
McClellan also touted the development of an active reporting system to bolster women’s access to information about drugs and treatments already approved. The system allows information on a drug to be electronically registered, so that patients and their doctors can have more complete and reliable information about its safety and efficacy in a timely fashion.
The SWHR Corporate Advisory Council seeks to bridge the gap between private industry executives and the women’s health community. This year’s meeting highlighted the continuing need to design clinical trials to account for sex differences in health.
“As the first FDA commissioner to address these issues in detail, we are honored that Dr. McClellan was able to join us today as the keynote speaker at our meeting on clinical trials,” SWHR President and CEO Phyllis Greenberger, M.S.W., said. “We support the FDA’s work to improve women’s health through innovative tools such as improved information sharing systems and targeted analysis of sex differences.”
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The Society for Women’s Health Research is the nation’s only not-for-profit organization whose mission is to improve the health of women through research, education and advocacy. Founded in 1990, the Society brought to national attention the need for the appropriate inclusion of women in major medical research studies and the need for more information about conditions affecting women disproportionately, predominately, or differently than men. The Society advocates increased funding for research on women’s health; encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease; promotes the inclusion of women in medical research studies; and informs women, providers, policy makers and media about contemporary women’s health issues. Visit the Society’s Web site at http://www.womenshealthresearch.org/site/PageServer for more information.