A Decade of FDA Advancing Health Equity
By: RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health
The U.S. Food and Drug Administration is working around the clock with our U.S. government partners, medical product manufacturers and international partners to address the coronavirus disease 2019 (COVID-19) pandemic. As the FDA remains steadfast in our urgent response efforts to the pandemic for all Americans, including the nation’s most vulnerable communities, I would be remiss not to pause for a moment to mark the importance of National Minority Health Month, observed every April. The commemoration highlights advancements that have been made, and steps we can continue to take, to increase health equity and reduce health disparities among diverse populations. This year, the occasion is especially significant because it marks the 10-year anniversary of the FDA’s Office of Minority Health and Health Equity (OMHHE), an office committed to reducing the health inequities minorities face that often contribute to reduced quality of life and premature death (watch the OMHHE video below to learn more).
Over the last decade, the FDA has increasingly focused on and delivered valuable public health information to underserved communities and patients, as well as other stakeholders in the public and private sector, academia, non-profit organizations, and regulated industry. The agency’s research and communications programs highlight the importance of health equity-focused research and its significance in developing medical products that are safe and effective for all. Now, more than ever, the FDA’s ability to respond to emerging threats and infectious diseases such as COVID-19 and deliver public health information is critical to ensuring the safety of the American public.
Some racial and ethnic minorities are disproportionally burdened by chronic disease and are much more likely to succumb to certain illnesses, making the need for tailored communication and research critical. We have seen this reported recently during the COVID-19 pandemic among minority communities within the United States. The FDA continues to work with our federal partners, academia, and other experts across the nation in our response to the COVID-19 pandemic and to amplify communications to diverse communities and the public at large. In our effort to provide the most current and accurate COVID-19 information, we have increased outreach by developing and disseminating COVID-19 health education materials for consumers in multiple languages, such as How You Can Make a Difference During the Coronavirus Pandemic (available in English, Spanish, and Chinese) and Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions (available in English and Spanish), that provide answers to questions consumers may have about COVID-19. These educational materials include general information and details on pertinent COVID-19 topics such as social distancing, diagnostic testing, vaccine development, fraudulent medical products, blood and plasma donation, and food safety. The agency’s official COVID-19 webpage has been translated into Spanish, and we’ve also created a COVID-19 Multilingual Resources webpage that features a growing collection of education materials in Spanish, Chinese, Korean, Vietnamese, and Tagalog.
Advancing Health Equity Through Communication and Outreach
The FDA’s OMHHE is proud to have fostered an award-winning communications program that amplifies the voice of the agency through culturally and linguistically tailored, easy to understand, health education materials that are shared with diverse groups. We have taken care to design our communications materials and approaches to help consumers make informed decisions when using FDA-regulated products. They include brochures on clinical trial diversity; fact sheets on diseases and conditions that disproportionately affect racial and ethnic minority populations (e.g., asthma, sickle cell disease); postcards to raise awareness about the FDA’s special efforts, like encouraging proper drug disposal; health equity webinars on minority health-focused research; videos highlighting the need for diverse representation in clinical trials; and other information across different social media platforms. This year, FDA OMHHE also published a special supplement in collaboration with the FDA’s Center for Tobacco Products on tobacco health equity in the Health Promotion Practice journal.
The FDA takes pride in employing a variety of strategies to reach diverse communities that we continue to adapt and evolve to make sure they are meeting needs. For example, more than 65 million Americans speak a language other than English at home, therefore the need for culturally and linguistically appropriate education materials is great. Our Language Access Program tries to meet our consumers at their place of need by providing information in multiple languages and formats to overcome communication barriers. Through this program we offer materials in Spanish, Chinese, Vietnamese, Korean, Tagalog, French, among others. These resources are widely available and are supportive tools for providers caring for multicultural patients.
To support the FDA in building a more culturally aware workforce, we developed a series of trainings to improve communications targeting diverse audiences, such as the “Communicating with Confidence: Strategies to Create Effective Communications for Diverse Audiences.” This training focused on cultural competency and sensitivity, and the knowledge, tools, and resources needed to produce multi-faceted communications for diverse consumers to help them make informed decisions when using FDA-approved products. Phase II of this training, to be launched later this year, will build on the first training and emphasize the impact of personal, and often unconscious, biases in health education and communications. Participants will learn how to recognize their biases and identify the impact of biased thinking and actions. They will also gain the ability to apply self-reflective and cultural knowledge-building practices to address biases that can hinder effective and culturally competent communication and education.
Closing the Health Disparities Gap Through Research and Collaboration
The FDA OMHHE’s Research and Collaboration Program works with FDA centers, offices, and external partners to support research studies about minority health and health disparities. OMHHE has supported research in a range of areas as well as projects through the FDA Centers of Excellence in Regulatory Science and Innovation and the FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science. Over the past decade, the FDA OMHHE has also hosted dozens of students and fellows with multidisciplinary backgrounds—ranging from physicians, health care providers, public health professionals, and scientists who represent minority serving institutions to better equip them with fresh knowledge and tools on critical health equity questions and to contribute to the nation’s public health workforce.
The FDA has also taken several actions to increase the amount and quality of clinical trial data available on racial and ethnic minorities to better understand how minorities react to medical products. In addition, the FDA has focused on increasing transparency and access to available data and strengthening our ability to respond to minority health concerns.
Looking to the Future of Health Equity
National Minority Health Month reminds us that while great strides have been made, many health disparity issues continue to need attention, for example in the areas of sickle cell disease, lupus, HIV/AIDS, among others. Over the coming years we will continue our work to broaden knowledge of—and access to—clinical trials through expansion of successful initiatives such as our clinical trial diversity campaign. We will continue to strengthen our ties with communities. This includes through approaches like memorandums of understanding, such as what we have in place with The Alliance of Multicultural Physicians and Yale University; both of which have an emphasis on increasing minority participation in clinical trials and expanding community engagement efforts. We also plan to identify and further broaden our support of diverse researchers and projects that explore subject areas to reduce health disparities.
The FDA remains focused and committed to advancing the health of all Americans, to another decade of expanding our outreach and research, and to closing gaps in health equity for all.