Scientific researchers now are working on an important topic: how to reduce health disparities among racial and ethnic minorities. And they’re doing it by collaborating with the U.S. Food and Drug Administration.
Health disparities refer to differences in the health status of different groups of people. These differences may affect how often a disease occurs (frequency), how serious a disease is (severity), or how often a disease results in death (mortality) among certain groups.
Health disparities exist for many conditions, including HIV/AIDS, hepatitis, diabetes, cancer, and heart disease. Racial and ethnic minorities may be more likely to have these diseases or may be more likely to have serious effects from them.
“Some of these differences may be partly due to the circumstances in which people are born, grow up, live, work and age, as well as by their differences in access to healthcare,” says Jonca Bull, M.D., director of the FDA’s Office of Minority Health (OMH).
“But we also need to explore whether there is a biological basis for these differences, including how safe and effective a medical product might be in the individual. It’s another way to focus the lens on personalized medicine.”
(Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research (CDER), describes what biomarkers are and why they’re important to the drug development process. Courtesy of the FDA and YouTube)
So the Office of Minority Health (OMH) Research and Collaboration program is strengthening the FDA’s ability to identify and address these disparities in several key ways.
General Activities and Scientific Research
Since its creation in 2010, OMH has focused on addressing minority health issues and on promoting effective public communication. And because the FDA is part of the U.S.
Department of Health and Human Services, the office also works on goals related to the department’s action plan (PDF 1 MB) for reducing health disparities.
“Each federal agency is unique and plays a role in understanding the complex causes of—and solutions for—health disparities,” explains Christine Merenda, M.P.H., R.N., manager of OMH’s intramural research program.
“Our office focuses on the role of FDA-approved medical products such as drugs, biologics, and devices, including how these products can potentially close the health disparities gap.”
OMH funds various research projects that can help the FDA better understand health issues, such as diabetes and heart disease, that affect minority populations disproportionately. These projects also can help with the agency’s decision-making process when it reviews medical products.
Funded projects include the following:
- Research at the University of Hawaii, Manoa, on the use of diabetes medication by Asians and Pacific Islanders living in that state
- An examination of health disparities in HIV/AIDS in minority women conducted by Meharry Medical College, and
- Research on Alzheimer’s Disease in African Americans and whether there are race-related differences in the disease’s biological markers.
OMH also helps advance the education of students and their understanding of health disparities through fellowships and the FDA’s Pharmacy Student Experiential Program.
Because the FDA uses data from clinical trials (voluntary human research) to determine whether medical products are safe and effective, the Office of Minority Health also helps educate medical product developers on best practices to collect race and ethnicity data for these trials.
(The FDA has launched a series of educational videos and materials to raise awareness about the importance of minorities participating in clinical trials. These videos stress the importance of why diversity is needed to help ensure medical products are safe and effective for everyone. Courtesy of the FDA and YouTube)
For instance, in October 2016, OMH published a guidance document, “Collection of Race and Ethnicity Data in Clinical Trials,” that provides recommendations for using a standardized approach for collecting and reporting race and ethnicity data in clinical trials for FDA-regulated medical products.
“Minority populations may respond differently to medical products. So sponsors for these products must submit a plan for racial and ethnic inclusion for clinical trials, and they have to do it at their earliest stage of development. It can’t be an afterthought,” explains Martin Mendoza, Ph.D., director of extramural research at OMH.
“Diversity in clinical trials is important, which is why this guidance is important as well.” (Read more about diversity in clinical trials on the FDA’s website.)
A Focus on Communication
Disparities also can be addressed through effective consumer communication. That’s why the FDA also funds communication research.
For example, one project at the University of Nebraska Medical Center explored how rural and urban Latinos in Nebraska accessed information about health promotion and disease prevention.
OMH also has funded research projects at the FDA’s Centers of Excellence in Regulatory Science and Innovation (CERSIs), which are collaborations between the agency and academic institutions.
The University of Maryland CERSI, for instance, worked to determine how the FDA can improve the health literacy and cultural competence of its own consumer communications.
Other research collaborations with outside entities, including the National Institutes of Health, universities, and other public and private partners, strengthen the FDA’s health disparities program.
“By collaborating with other federal agencies and academic research centers, we benefit from their expertise and their investments in research related to our interests,” Merenda explains.
And the FDA’s Office of Minority Health remains committed to improving public health for all Americans.
“The fight against health disparities is a major FDA focus,” adds Bull.
“Helping to ensure that patients fully understand best practices for good health, and how to safely and effectively use FDA-approved medical products, is a priority.”
This article appears on the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.