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  • Washington Highlights

    Cooper, Lummis Reintroduce Research for All Act

    Tannaz Rasouli, Sr. Director, Public Policy & Strategic Outreach

    Reps. Jim Cooper (D-Tenn.) and Cynthia Lummis (R-Wyo.) May 5 reintroduced bipartisan legislation that would bring gender equality to essential aspects of medical research.

    First introduced in the 113th Congress, the Research for All Act would require the inclusion and separate analysis of male and female animals, tissues and cells in research conducted and funded by the National Institutes of Health (NIH).

    The bill also directs the Food and Drug Administration (FDA) to guarantee that clinical drug trials for expedited drug products are sufficient to determine safety and effectiveness for both men and women.

    In an April 27 letter endorsing the bill, AAMC President and CEO Darrell Kirch, M.D., said the legislation “represents an important step toward gender equity in heath by improving our understanding of sex differences in both basic and clinical research…”

    Dr. Kirch noted, “This legislation builds on and supports initiatives that NIH is already undertaking to address many of these critical issues. The AAMC is encouraged that the legislation calls for the NIH Director to determine the appropriateness of including both male and female cells, tissues, or animals in basic research after consultation with the scientific and academic communities, and provides for the Director to exempt such inclusion where inappropriate.”

    “In particular, the AAMC supports the idea of the bill’s proposed outreach and educational initiatives on the influence of sex as a variable in basic research to help develop a consensus within the scientific and academic communities on when it is appropriate for basic research to include both male and female cells, tissues, or animals,” Dr. Kirch said.

    In addition, the letter stated, “The AAMC also fully supports the goal of increasing the participation of women in clinical trials and believes this legislation will help insure that by mandating NIH to update its guidelines to enforce better the current law on inclusion of women in clinical research.”

    The bill also directs the Government Accountability Office (GAO) to update its 2000 report “Women’s Health: NIH Has Increased Its Efforts to Include Women in Research” and its 2001 report “Women’s Health: Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement.”