FDA’s Strategies to Close the Health Equity Gap among Diverse Populations

Abstract

This commentary provides an overview of the Food and Drug Administration’s Office of Minority Health and Health Equity.

Health Disparities continue to exist in this country; closing the health equity gap is challenging and will take a multi-faceted approach with changes needed at the individual, community, organizational, and policy level. Health equity is defined as the “attainment of the highest level of health for all people.” ¹ Achieving health equity will take a concerted effort from all sectors to address the systemic barriers that prevent people from making well-informed decisions about their health and well-being. There is no quick or easy fix to this complex problem peppered with historical abuses that have negatively impacted our most vulnerable communities.

Racial and ethnic minorities continue to experience higher rates of mortality, morbidity, and worse health outcomes across many chronic diseases—especially cardiovascular disease, diabetes, hepatitis, and some cancers. Social determinants of health such as limited English proficiency, low health literacy, lack of education, lack of access to quality health care, among other factors influence people’s decision making around their health and ability to utilize their health care. ³ For example, only 12% of adults have “proficient health literacy” and low health literacy is more prevalent among minorities, older adults, and those with low socio-economic status. ³ Additionally, about 20% of the United States population speaks a language other than English at home. Having limited English proficiency and/or low health literacy greatly limits one’s ability to interact effectively with the healthcare system (eg, seek medical advice), contributing to poor health outcomes.^2,3

The Food and Drug Administration (FDA), Office of Minority Health and Health Equity (OMHHE) was established in 2010 to strengthen FDA’s ability to respond to minority health concerns, advance minority health and health equity focused research, improve FDA communication with diverse populations, and advocate for the inclusion of racial and ethnic minority populations in clinical trials. The mission of OMHHE is to promote and protect the health of diverse populations through research and communication that addresses health disparities. The collection of articles featured in this “Health Equity Special Collection Issue” showcase some of the strategies that the FDA is using to actively advance health equity.

Specifically from a public health communications perspective, health education and promotion activities should use an equity lens that includes addressing culture and language barriers. Culture must be considered when designing health education and promotion programs and initiatives; recognizing how culture impacts one’s ability to interact with the health system, seek health information, and make decisions about their health and wellness. There is a not a one size fits all approach that will work for every community. Diversity needs to be authentically represented in materials (eg, graphics and images), community members need to be included in the development process, relevant dissemination strategies should be used, and materials should be translated into other languages to meet each community’s unique needs. Materials and programs that are developed should be disseminated using strategies that are most likely to resonate with each group that will encourage and support them to make healthy choices. This may require out-of-the box thinking and going beyond using the traditional dissemination channels. It is imperative to ensure that everyone has the tools and resources needed to make decisions about their health in a manner they can understand and act on. For example, this may mean having translators available during medical appointments, writing health education materials at a lower literacy level and translating into other languages, or using bigger fonts, incorporating graphics that reflect the diversity of each community, or making materials accessible in different formats (eg, digital or print).

OMHHE is committed to advancing health equity and works across all FDA product centers and offices, as well as with a broad range of public and private stakeholders, to accomplish its mission. A key component of OMHHE efforts includes raising awareness about clinical trial diversity, educating diverse consumers on diseases and conditions that disproportionately impact racial and ethnic minority groups (eg, diabetes, heart disease, sickle cell disease, lupus), and supporting intramural and extramural minority health research projects.

OMHHE’s communication efforts include developing culturally and linguistically tailored health education materials for racial and ethnic minority and underrepresented consumer groups, written at low literacy levels using plain language and translated into multiple languages. Materials have been translated into Spanish, Vietnamese, Chinese (Simplified and Traditional), Tagalog, among many others. These communications are designed to strengthen consumer’s decision-making regarding FDA-regulated products and include items like brochures, fact sheets, post cards, and digital content such as videos and social media messages.

The “Language Access Program,” led by OMHHE ensures that FDA’s health education materials are translated accurately and appropriately. OMMHE created a novel volunteer’s program that enlists FDA staff who are native speakers of a language other than English to review translated products before releasing to the public. Additionally, through this program, OMHHE engages with internal and external stakeholders to ensure we are meeting the needs of our multi-lingual communities. Through these efforts, we have translated hundreds of materials into over 30 languages.

The “Health Equity Lecture” series is another avenue to raise awareness and educate stakeholders about minority health. OMHHE hosts thought leaders from across the nation to lecture on emerging research, programs, and strategies that help to advance minority health. We have featured lecturers from academia, government, non-profit organizations, among others to talk about issues like sickle cell disease, HIV, asthma, and diabetes, all conditions disproportionately impacting racial and ethnic minorities.

OMHHE research projects have contributed to the assessment of safety and efficacy of FDA-regulated products among diverse populations, and focused on areas such as product labeling, precision medicine, multiple myeloma, clinical trial diversity, sickle cell disease, Alzheimer’s Disease, and lupus, to name a few. In addition, social listening tools have helped support OMHHE’s portfolio of knowledge and promoted health and safety communication to strengthen patient and consumer decision-making of FDA-regulated products.

A recent example of OMHHE’s research is the “Science of Engagement: Social Listening for Patient Perspectives” project. OMHHE funded an intramural research study to capture the patient voice using unstructured data from social media and FDA archival data sources. The methodology was highlighted at research plenary presentations and posters, published in the journal of Research in Social and Administrative Pharmacy as well as informed future research with FDA in understanding how to capture the patient voice for chronic pain (opioid abuse) using social media. This research enhanced FDA’s ability to understand how to capture the diverse patient voices employing novel methodology and data sources.

Diversifying the workforce pipeline is also critical to closing the health equity gap. Over the past decade, we have hosted dozens of student interns and fellows to help advance their knowledge on health disparities and issues pertinent to racial and ethnic minority communities. Additionally, we have implemented staff level trainings to improve health communications by addressing cultural competency and bias.

The examples provided here are just a highlight of the breadth and depth of OMHHE’s portfolio of health education resources, research projects, and strong stakeholder outreach to demonstrate our ongoing commitment to advancing health equity. Given FDA’s responsibility to regulate a wide range of medical products, the Health Equity Special Collection Issue is a compilation of manuscripts highlighting some of FDA’s contributions towards advancing health equity and regulatory science. We hope that you find the articles presented here insightful and contribute to your knowledge about FDA’s work to promote the health and well-being of all.

For more information, visit www.fda.gov/healthequity.