Dr. Yeboah: Absolutely! The FDA Office of Minority Health (OMH) was established in 2010, as mandated by the Affordable Care Act. OMH serves as the principal advisor to Commissioner Hamburg on minority health and health disparities. I’m currently the Acting Director, and have been on board since the inception of the Office.
FDA Voice: What is the mission or vision for the office, and how did you develop it?
Dr. Yeboah: Our regulatory mission is to reduce racial and ethnic health disparities and achieve the highest standard of health for all. In doing so, we focus on three key areas:
1) Strengthening FDA’s capacity to address minority health and health disparities through coordinated leadership on regulatory actions and decision making across the agency.
2) Promoting effective communication and the dissemination of information to the public, particularly underserved, vulnerable populations.
3) Improving and strengthening the research and evaluation of sub-population data associations with race and ethnicity.
This mission for OMH was developed after discussions with health professional groups, academicians, advocacy groups, industry and a cadre of leaders in the area of minority health.
FDA Voice: Can you tell us more about your initiatives to improve FDA’s ability to address minority health and health disparities among racial and ethnic populations?
Dr. Yeboah: OMH explores the intersection between regulatory science and health disparities. The 2010 US Census estimates that minorities account for 46% of the overall US population, and current health statistics highlight poorer health outcomes for African American, American Indian and Alaska Native, Asian American, Hispanic American, Native Hawaiian and Pacific Islander communities. Across racial and ethnic groups, a disproportionate share of minority communities are more likely to die from serious health issues such as diabetes, heart disease, cancer and asthma, to name a few.
The scientific need for understanding health disparities through scientific research is critical to eliminating health inequities and ensuring the highest standard of health for all.
As highlighted in FDA’s Strategic Priorities 2011-2015, expanding efforts to meet the needs of special populations is a crosscutting agency priority. Strengthening FDA’s capacity to understand the complexities associated with minority health and health disparities can lead to better health outcomes for the most vulnerable communities, whether it is through epigenomics, personalized medicine or targeted risk communication among underserved populations.
In May we held a Webinar entitled Steps to Addressing Health Disparities. The Webinar discussed the establishment of the Office of Minority Health at FDA and also discussed agency efforts to ensure the safety, efficacy, and security of regulated products among vulnerable populations.
FDA Voice: We’d love to hear about the initiatives and partnerships you are working on to address health disparities. I know there are a lot of them, but if you could give us some details that would be great!
Dr. Yeboah: Yes – as we talked about, OMH is looking to find opportunities for collaborating in the areas related to minority health, health disparities and issues of personalized medicine. So far this year we have been able to finalize four University-based research partnerships:
- University of Hawaii Hilo, College of Pharmacy
- Meharry Medical College, Center for AIDS Health Disparities Research
- University of Nebraska, Rural Health Education Network
- University Of Hawaii Manoa, Office of Public Health Studies
These partnerships are solely focused on examining minority health and health disparities from a regulatory perspective. For example, we have a research Memoranda of Understanding (MOU) with the University of Hawaii, Hilo College of Pharmacy, to work on reducing disparities in diabetes treatment and outcomes among Asian and Pacific Islander Americans living in Hawaii. And, to date, we have established partnerships with several Universities exploring issues of disparities in diabetes, tobacco and HIV/AIDS.
We have additional University-based research partnerships that are pending and have several collaborations with other organizations including the National Institutes of Health, with whom we are co-sponsoring the 2012 Summit on the Science of Eliminating Health Disparities: Building a Healthier Society, Integrating Science, Policy and Practice, in the fall. We are also partnering with the Centers for Disease Control and National Hispanic Alliance. We look forward to growing additional partnerships to address issues of health disparities from a regulatory perspective.
Find out the details on our MOU’s. We have a lot of exciting and promising activities on the horizon at OMH!
FDA Voice: How is the Office of Minority Health helping to diversify the FDA Advisory Committees?
Dr. Yeboah: Last year OMH began a new initiative called “Enhancing Diversity on FDA Advisory Committees.” The goal is to broaden the search for qualified advisory committee candidates who have experience with underserved communities.
Advisory committees are essential in supporting FDA’s mission of protecting and promoting the public health by obtaining independent expert advice on scientific, technical, and policy matters. Promoting FDA’s leadership role in addressing health disparities and assuring diverse perspectives on advisory committees are integral to achieving the agency’s public health mission.
The expertise provided by advisory committee members is essential for understanding the safety and efficacy of regulated products on the target population, especially racial and ethnic populations, who are often disproportionately impacted by higher rates of disease, disability and premature death for conditions ranging from cancer to cardiovascular disease and HIV/AIDS to name a few.
It is critical that FDA Advisory Committee members have the expertise and experience necessary to effectively consider the impact of regulated products on racial and ethnic populations. Health professionals from racial and ethnic minority groups or who serve in minority communities often possess valuable experience in the prevention, diagnosis and treatment of disease among racial and ethnic minorities.
FDA Voice: I understand the Office of Minority Health is also helping to strengthen research with clinical trials. Can you talk about that a bit?
Dr. Yeboah: We collaborated with FDA’s Office of Women’s Health, the Society for Women’s Health Research, and industry representatives, and held the “Dialogues on Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities” conference late last year to explore promising practices in clinical trials for the inclusion of women and minority populations. The meeting drew a cadre of professionals from various fields including pharmaceutical industry representatives, health care providers, patient advocacy groups and academia.
OMH continues to pursue the overarching goals discussed at the conference: to increase the participation of underserved populations in clinical trials with resulting improvement in clinical care and positive health outcomes, and to share successful practices in the recruitment, retention and analysis of women and minorities in clinical trials. For additional information about the conference or our office please visit the OMH Webpage.
Michelle Yeboah, Dr.P.H., is Director of FDA’s Office of Minority Health (Acting)