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Second Opinion

Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

AAMC Calls for Broader, Long-Term Engagement by FDA

April 4, 2014—AAMC Chief Scientific Officer Ann Bonham, Ph.D., presented oral remarks April 1 at a hearing of the Food and Drug Administration (FDA) on broadening inclusion and representation of communities in research that becomes the basis for FDA’s regulatory and other decisions.  The FDA Office of Minority Health held the day-long session specifically to receive public comments on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data, such as sex, race, ethnicity, or age, in applications for approval of FDA‐regulated medical products.

In her prepared remarks , Dr. Bonham proposed strategies for improving enrollment of individuals from diverse communities, and for better communication and dissemination of research results and new approved health products to all affected populations.  Dr. Bonham stressed that the end point of recruitment initiatives was not simply to achieve better representation in clinical trials.  She noted, “The regulatory and research community recognize that recruitment is not the first step, but rather that building and sustaining trust with the communities is the first step.”

Dr. Bonham continued, “Increasing the participation and sense of belonging to a broadly defined health and research-ready community will require providing incentives, expectations, and resources for engaging and learning from communities to build ties and trust.  This is a marathon, not a sprint, and boom-bust engagement with communities linked to funding will undermine developing effective partnerships for minority groups to benefit from discoveries.”

Paula Johnson, M.D., M.P.H., of Brigham and Women’s Hospital and the lead author of that report, also presented comments, among a score of other representatives from academe, industry, and patient advocacy organizations.  Her 2014 report, “Sex-Specific Medical Research: Why Women’s Health Can’t Wait,” underscores how much research that informs medicine — including the prevention, diagnosis, and treatment of disease — routinely fails to consider the crucial impact of sex and gender.

The FDA has stated that input from the public hearing will be used to develop “pragmatic and public‐health focused” plan for better engagement and inclusion.  The FDA will accept public comments until May 16, 2014.

Contact:

Stephen Heinig
Director, Science Policy
Telephone: 202-828-0488
Email: sheinig@aamc.org

Philip M. Alberti, PhD
Senior Director, Health Equity Research and Policy
Telephone: 202-828-0522
Email: palberti@aamc.org

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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org