Meeting With Secretary Kathleen Sebelius (June 9, 2010)

Phyllis Greenberger, SWHR President and CEO, and Martha Nolan, Vice President, Public Policy met with HHS Secretary Kathleen Sebelius and Dora Hughes, HHS Counselor for Public Health and Science Policy to discuss SWHR’s 20 years of work to improve women’s health: the inclusion of women in clinical trials, sex differences research, and SWHR advocacy efforts. Some of these efforts include comparative effectiveness research (CER) as part of the stimulus bill, Women’s Health Office Act (WHOA) in health care reform, and the appropriate use imaging and diagnostic tools for prevention and early diagnoses.

The Secretary was interested in SWHR’s information regarding women in clinical trials and surprised that sex still is not a fundamental component of all research in the development of drugs, devices and biologics. The Secretary understood how important SWHR’s issues were to determinations being made under comparative effectiveness research, especially with the newly developing Patient-Centered Outcomes Research Institute. The Secretary was informed of SWHR’s testimony, both written and oral, to the NIH/FDA last week regarding the need for consideration of sex differences in “regulatory science,” the newly coined term from the NIH/FDA collaborative.