Working to Raise Awareness and Reduce Health Disparities

By: Jonca Bull, M.D.

Minority Health Month imageApril is National Minority Health Month and this year’s theme is “Bridging Health Equity Across Communities.”

FDA’s Office of Minority Health (OMH) is committed to the HHS mission of advancing health equity, and our office works year-round to advance FDA’s message of ensuring the safety and efficacy of our nation’s food supply and medical products to all communities, but with a focus on minority groups. The first HHS Office of Minority Health was established nearly three decades ago and FDA’s own office came into being in 2010.

Jonca Bull, M.D., is Director of FDA’s Office of Minority HealthIn the intervening years, we have made significant progress. But we are reminded daily that there is still more to be accomplished in the fight to reduce and eliminate health disparities.

Today, minority communities and those at the lower socioeconomic rungs still remain disproportionately burdened by chronic disease and are much more likely to succumb to certain illnesses.

Within the past year, we have worked diligently to connect our communities to resources to help educate and raise awareness about these issues. Highlights from our two programmatic teams include:

Outreach and communications –

Released English and Spanish language videos to encourage minority participation in clinical trials, with the most recent video being released this month;

  • Worked closely with the health fraud team in the Office of Regulatory Affairs to raise awareness about tainted and fraudulent products that target some ethnic groups;
  • Exhibited and presented at nearly a dozen conferences throughout the year; and,
  • Spearheaded the agency’s Language Access plan to help ensure that FDA materials are available to all consumers in their native language.

Research and Collaboration –

  • Worked with FDA centers and external partners to support research studies around minority health and health disparities. Projects included: Racial Disparities in Multiple Myeloma, Underutilization of Generic Medications in Underserved Patients, and Advertising and Promotional Labeling in Adult Immunization Disparities.
  • Funded multiple Centers for Excellence in Regulatory Research Science and Innovation (CERSI) projects with Georgetown University (Targeting triple negative breast cancer in African American women), University of California San Francisco/Stanford (Safer Labeling of Pediatric Medications: Reducing Literacy-related Health Disparities among Chronically Ill Adolescents), Johns Hopkins University (Workshop Clinical Trials: Assessing Safety and Efficacy for a Diverse Population);
  • Supported a genomics and health disparities fellow at Harvard University School of Medicine; and,
  • Hosted more than half a dozen fellows and pharmacy students from Howard University, the University of Washington, and Florida Agricultural and Mechanical University, among others.

In addition, last fall, OMH issued a draft guidance document titled, Collection of Race and Ethnicity Data in Clinical Trials-Guidance for Industry and FDA Staff with the goal to ensure that subpopulation data is collected consistently by industry. This document outlines FDA’s expectations for, and recommendations on, the use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated medical products conducted in the United States and abroad. We also hosted a webinar to walk through the document.

Working collaboratively within FDA and with external stakeholders, we will continue promoting and protecting the health of diverse populations through research and communicating of science information that addresses health disparities.

Jonca Bull, M.D., is FDA’s Assistant Commissioner for Minority Health, Office of Minority Health

For more information read: The FDA Supports Research to Reduce Health Disparities

Advancing Science and Building a Healthier Society

By: Theresa Castillo

Knowledge and education are critical, but “passion and perseverance” are also needed to eliminate health disparities, Assistant Health and Human Services Secretary Howard Koh, M.D., told a group gathered to pursue the goal of better health for all.

Dr. Koh’s call for even greater commitment was issued to more than 4,500 people who attended the Summit on the Science of Eliminating Health Disparities at the Gaylord National Resort and Convention just outside of the nation’s capital in December 2012. Since then, individuals and groups around the nation have returned to their jobs with new information gained from some of the more than 100 workshops that explored emerging sciences, policies and practices that can help eliminate health disparities that disproportionately affect minority groups.

Here at FDA, we are now in the midst of collaborating with the National Institutes of Health to publish recommendations and best practices that were highlighted at the summit and worthy of adoption on a broader scale. Articles published in peer reviewed journals also will be available at FDA’s Office of Minority Health Web site later this year.

The summit was led by the National Institute on Minority Health and Health Disparities and co-sponsored by FDA’s Office of Minority Health and the U.S. Department of Health and Human Services. Leaders in government, academia, business, medicine, science and public policy joined with advocates and others in the community to learn, share and build new alliances.

The ultimate goal: to share creative and innovative solutions that can be adopted widely to improve health in theU.S.and around the world.

The work on health disparities arises from a critical need. For example, African American men are 2.4 times more likely to die from prostate cancer than non-Hispanic white men, 10 times more likely to die of AIDS, and 60% more likely to die of stroke. Native American women are almost twice as likely to die of diabetes than non-Hispanic white women. And while Asian and Pacific Islanders are less than 5 percent of the population, they account for more than 50% of Americans living with chronic Hepatitis B and associated liver cancer.

The numbers reflect a complex web of causes, including unequal access to health care, environmental issues, genetic differences and lifestyle, to name a few. These variables and more were addressed at the summit.

The breadth of the effort is exemplified by listing even a few of the more than 100 workshop and roundtable titles: “Approaches for Identifying and Addressing Environment Health Disparities,” “Public Policies and Strategies to Address Obesity Prevention,” and “Reducing Health Disparities through Innovation.”

The summit brought together some of the nation’s foremost experts. Speakers included former U.S. Health and Human Services Secretary Louis Sullivan, M.D., NIH director Francis S. Collins, M.D., Ph.D.,  Mary Woolley, head of Research!America,  Kira Fortune, Ph.D. of the Pan American Health Organization, and David Fukuzawa of the Kresge Foundation.

The energy, commitment and knowledge gathered in one place left me inspired and convinced that together, we are on a path that will lead to improving health for all.

Theresa Castillo is a public health advisor in FDA’s Office of Minority Health