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

FDA Celebrates 30 Years of Advancing Health Equity

By: Jonca Bull, M.D.

April is Minority Health Month! I am proud to say that FDA’s Office of Minority Health (OMH), in collaboration with  the Department of Health and Human Service’s Office of Minority Health, is celebrating this year’s theme: “30 Years of Advancing Health Equity, The Heckler Report: A Force for Ending Health Disparities in America.” For us at FDA, this year also marks the 5th anniversary of OMH, which serves as the principal advisor to the Commissioner on minority health and health disparities.

Jonca BullThe Heckler Report was a major, ground breaking document that transformed HHS’s views and actions on minority health. For the first time in history, representatives from each agency convened to talk about minority health and, more importantly, put forth recommendations to achieve health equity. Findings illustrated huge disparities between African Americans and other minorities compared to the population at large for key health indicators, such as life expectancy and infant mortality. Key recommendations relevant to FDA’s mission centered around health information and education, cooperative efforts (inside and outside of the government), health professions development, data development, and developing a research agenda.

Let’s stroll down memory lane and recap FDA’s activities that resulted from the Heckler report.

Health Information and Education 

FDA has developed numerous outreach activities to improve consumer education and access to health information by utilizing the best cultural and linguistic practices to reach diverse minority populations. Hosting symposiums and webinars, participating in conferences, exhibiting in health fairs, and creating consumer educational materials are just some of the activities FDA has carried out to raise awareness and educate the public. Most recently, OMH has created a social media presence on Twitter and Pinterest, and maintains an active listserve with a quarterly newsletter. One of our most successful outreach campaigns has been the “Heart Health Toolkit” for American Heart Month, which reached over 6,000 people in February.

Our most recent consumer outreach occurred on March 25th via a webinar on how the public can respond to requests for comments on regulatory proposals and public health issues by using FDA dockets.

Cooperative Efforts/Health Professions Development

OMH embraces the notion that protecting the public’s health cannot be done in isolation. We have focused on four areas to improve stakeholder relations:

  • Work with Industry to increase diversity in clinical trials;
  • Work with minority serving institutions and organizations to implement strategies and programs to improve regulatory science (specific to minorities);
  • Provide platforms for stakeholders to become informed and involved about our work; and,
  • Host and promote mentoring programs to encourage minorities to stay in scientific and academic careers.

Data Development and Research Agenda

We have a robust research agenda that focuses on advancing regulatory science related to eliminating health disparities. The agenda consists of various intramural and extramural grant programs, giving preference to minority-serving institutions. FDA also promotes and funds research that aims to increase the quantity, and improve the quality, of data on minorities, and to make these efforts transparent to the public.

In short: FDA has been and will continue to be committed to narrowing the health disparities gap. OMH will continue our legacy of creating culturally and linguistically tailored tools, materials, and resources for minority communities to increase their awareness and understanding of FDA’s mission and of the products that FDA regulates, increase their participation in clinical trials, and increase diversity in the workforce. This ensures better representation in the workforce, and most importantly: better health for all minorities!

More information about specific programs can be found on our website.

The Heckler Report can be found at: http://collections.nlm.nih.gov/catalog/nlm:nlmuid-8602912-mvset.

Jonca Bull, M.D., is Director of FDA’s Office of Minority Health

Honoring African American History by Increasing Access to Information Protecting and Promoting Your Health

By: Walter Harris

African-American History Month offers the opportunity to reflect on the contributions of African Americans in various ways, both in our local communities and on a national scale. 

Walter HarrisWe should also use this month of observance to note the public health disparities that continue in underrepresented and underserved communities.  Current CDC health statistics highlight poorer health outcomes for the African American, American Indian and Alaska Native, Asian American, Hispanic American, Native Hawaiian, and Pacific Islander communities. 

FDA’s Office of Minority Health (OMH), established in 2010 as a mandate of the Affordable Care Act, works to reduce racial and ethnic health disparities and to support achieving the highest standard of health for all.  A key effort to advance this mission is to promote effective communication and the dissemination of information to the public, particularly underserved, vulnerable populations. 

FDA’s website has a wealth of resources to help minority communities use safe medicines, foods, and other products the Agency regulates.  Whether you are a patient, student, health professional or caregiver, reading in English or Spanish, our website has resources to help you stay informed and stay healthy. 

We are continually working to improve user experience on FDA.gov.  We recently launched the mobile version, as our increasingly mobile stakeholders and workforce require creative approaches to keep our data and systems accessible on mobile platforms. We are also working to significantly improve the search capabilities on the website, as well as maintaining Section 508 compliance to ensure that www.FDA.gov content is accessible to people with disabilities. OMH also works to improve and strengthen the research and evaluation of subgroup demographic data associations with race and ethnicity, particularly how data is represented in clinical trial participation, safety and effectiveness data.  As a participant in FDA’s Data Standards Council, OMH helps to coordinate the evaluation, development, maintenance, and adoption of health and regulatory data standards for race and ethnicity to ensure that common data standards are used throughout the agency. 

FDA’s Office of Information Management and Technology is engaged in various ways to improve the availability of data for consumers, researchers, developers, and industry.  More than 80 resources are currently indexed publicly, many updated daily, including adverse drug events, reports involving medical devices, searchable listings of over-the-counter tests cleared or approved by the FDA, and a database of accredited mammography facilities. 

Our goal is to increase the transparency of FDA data to the public through the openFDA initiative, which is being run by the newly-established Office of Informatics and Technology Innovation. We plan to provide access to multiple high-value structured data sets to consumers, including the mobile app and software developer community, starting in Summer 2014.

FDA believes that access to this data will further the Agency’s regulatory mission and, most importantly, will help inform minority and underserved populations – as well as  the general population – on ways to improve their health. In support of this goal, we must break many of the traditional technology infrastructure barriers by implementing cloud technologies to better support the exponential growth of data we are managing. We are also leveraging this ingenuity to address, for example, analyzing and sharing large amounts of information such as applying Next Generation Sequencing for generating, analyzing, reviewing, and sharing genetic information.

I encourage all of us to commemorate this month by not only reflecting on the drive and inspirational spirit of past and present African Americans, but to also taking the time to think of how we can apply that same drive and spirit to our mission of protecting and promoting public health. 

Walter Harris is Deputy Commissioner for Operations and Acting Chief Information Officer, Food and Drug Administration