FDA Insight: Episode 21 – Transcript
>> Anand Shah: Welcome back to another episode of FDA Insight.
I’m Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. Thank you for joining us for another great episode.
This week, we’ll be discussing FDA efforts to address minority health as the agency continues to work on solutions to eliminate health disparities among diverse racial and ethnic populations.
My guest today is Rear Adm. Chardae Araojo, the Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity, or OMHHE, in the Office of the Commissioner at the FDA. Admiral Araojo provides leadership, oversight, and direction on minority health, health disparity, and health equity matters for the agency.
Admiral Araojo previously served as the Director of the Office of Medical Policy Initiatives in FDA’s Center for Drug Evaluation and Research where she led a variety of broad-based medical and clinical policy initiatives to improve the science and efficiency of clinical trials and enhance professional and patient labeling.
Admiral Araojo, welcome to FDA Insight.
>> RADM Araojo: Thank you, Dr. Shah, for having me on the show. It’s great to be here.
>> Anand Shah: Well, let’s jump right in. Congratulations on the Office of Minority Health’s 10-year anniversary. Can you tell us about the office and its public health mission?
>> RADM Araojo: Sure, the Office of Minority Health and Health Equity aims to protect and promote the health of racial and ethnic minority, underrepresented and underserved populations by focusing our efforts on research and outreach and communication that works towards addressing health disparities. FDA established the Office of Minority Health in 2010, and we were renamed to the Office of Minority Health and Health Equity in 2019. We are excited about our new name as it highlights the scope of the work we have performed over the past decade and what we will continue to do to advance health equity.
To provide a little more background, our office works broadly across the agency as well as with public and private sector stakeholders. And we have three overarching goals:
We aim to increase the amount of clinical trial data available on the populations that we serve. We aim to strengthen FDA’s ability to respond to minority health concerns and promote health and safety communication to populations who often experience low health literacy, speak English as a second language, or not at all.
>> Anand Shah: And speaking of the Office of Minority Health and Health Equity’s anniversary, can you highlight what the office has done?
>> RADM Araojo: Over the last decade, we have worked to advance our research and communications programs. We have increasingly focused on and delivered valuable culturally and linguistically tailored public health information to diverse communities and patients, as well as to other public and private sector stakeholders, including academia, non-profit organizations, and regulated industry. These include brochures and videos on the need for clinical trial diversity; fact sheets on diseases and conditions that disproportionately affect racial and ethnic minority populations like asthma and sickle cell disease, as well as postcards to raise awareness about FDA’s efforts, such as encouraging proper drug disposal.
We have also worked to support research on advancing minority health and health equity, the understanding of health disparities, and projects that provide future directions for research that contribute to regulatory decision-making. A key component of this is also highlighting the importance of health equity-focused research and its significance in developing medical products that are safe and effective for the diverse groups that will ultimately use them.
And to highlight some of our work over this past year, we published a special journal supplement in collaboration with the FDA’s Center for Tobacco Products on tobacco health equity in the Health Promotion Practice journal which featured 18 articles focused on tobacco-related research, interventions, and programs that contribute to understanding health disparities among diverse populations. And in response to the opioid crisis, we also hosted a public meeting on Strategies to Improve Health Equity Amidst the Opioid Crisis with speakers from across the government including FDA senior leaders as well as the U.S. Surgeon General.
>> Anand Shah: Admiral, as we’ve heard over many months, the medical community has reported the COVID-19 pandemic has disproportionately affected racial and ethnic minority populations. Can you tell us how your office is supporting FDA’s response to the pandemic?
>> RADM Araojo: We continue 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 increased outreach by disseminating COVID-19 health education materials for consumers in multiple languages.
We also supported the development of the FDA COVID-19 Multilingual Resources webpage that features a growing collection of educational materials in Spanish, Chinese, Korean, Vietnamese among a number of other languages. These educational materials are very important as they provide details on pertinent COVID-19 topics such as social distancing, diagnostic testing, vaccine development, fraudulent medical products, blood and plasma donation, as well as food safety.
We have also worked to increase amplification of clinical trial diversity messages, and we held a listening session with stakeholders so that we could learn more about the gaps and needs of diverse communities and to share information on FDA’s COVID-19 activities.
To further enhance our outreach and dissemination, we provide weekly communications through our email listserv on FDA’s COVID-19 information.
We also launched a COVID-19 Bilingual Social Media Toolkit that features consumer friendly messages and culturally appropriate graphics. This shareable toolkit allows stakeholders to have ready to use messages that can be shared with diverse audiences to ensure consistent messaging.
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 really critical to ensuring the safety of the American public.
>> Anand Shah: What is the Office of Minority Health and Health Equity doing to encourage minority and underrepresented populations to enroll in clinical trials?
>> RADM Araojo: Advancing diverse participation in clinical trials is a priority for the Office of Minority Health and Health Equity. We know that racial and ethnic minority populations continue to be underrepresented in clinical trials. This is due to factors including a lack of trust in the medical system—in part due to past historical abuses—as well as other barriers like a lack of transportation, time, or knowledge about clinical trials and research opportunities.
And while great strides have been made to build trust, confidence and access, many health disparity issues continue to need attention. Over the coming years we will continue our work to broaden knowledge of clinical trials through expansion of successful initiatives such as our ongoing clinical trial diversity campaign in which we are always adding new tools and resources like the most recent addition to this campaign that we developed in collaboration with the Center for Devices and Radiological Health on the importance of diverse participation in medical device clinical trials.
>> Anand Shah: What types of resources does the Office of Minority Health and Health Equity provide to patients?
>> RADM Araojo: We develop culturally and linguistically tailored infographics, brochures, factsheets, public service announcements or videos, and other health education resources for consumers covering everything from safe medication use, topics related to clinical trial diversity, and information on health disparities – all of which are available on our website as well as the FDA’s various online platforms for both medical professionals and patients to use.
And a key component to this effort is our Language Access Program that works to provide information in multiple languages to meet the needs of our diverse audiences.
>> Anand Shah: How does your office support public education and information?
>> RADM Araojo: One of the ways we help educate and inform is by maintaining a Resources by Health Topic webpage that compiles easy-to-use and culturally-appropriate resources on minority health, health disparities, and related topics. These resources are available to view online, print, or share. And some of these are available in Spanish as well as many other languages. We also host a health equity lecture series that features freely available webinars for the public on minority health and health equity focused topics, research and scientific initiatives.
>> Anand Shah: How does the office work with industry and other stakeholders to improve minority health?
>> RADM Araojo: One way we work with industry and a broad group of stakeholders is through raising awareness on the need for diverse participation in clinical trials through our ongoing diversity in clinical trials campaign. Additionally, through our Research and Collaboration Program we work with FDA centers and external partners to support research studies about minority health and health disparities.
These studies aim to: reduce health disparities by advancing minority health and health equity focused research, education, and scientific exchange. We aim to study medical conditions that disproportionately affect racial and ethnic populations as well as analyze data sets that address FDA concerns or questions. We also study human genetic variation in susceptibility and severity of medical conditions and conduct usability testing among diverse stakeholders and consumers to improve comprehension of FDA’s communications.
>> Anand Shah: Admiral, what do you see as the biggest challenge to minority health or health equity today?
>> RADM Araojo: Our nation is comprised of such a diverse group of racial and ethnic populations that it is really not possible to really pin down one priority. One disease may disproportionately impact one diverse group over another. And these disparities in health span everything from cancer and diabetes to heart disease, sickle cell disease, and HIV/AIDS among a number of other diseases and conditions. No one should face health inequities, and the FDA considers any disparity a priority and continues to work on these issues.
>> Anand Shah: As you begin to plan for the next 5-7 years, can you give us a sneak peek and tell us what types of events and campaigns we can expect to see from the Office of Minority Health and Health Equity?
>> RADM Araojo: Sure. This year, we opened a public docket in January of this year to solicit input from stakeholders in establishing strategic priorities for the office to ensure important public health concerns are carefully considered as we establish our priorities. We are actively reviewing the comments that we received and will use this feedback to guide our work in the coming ears. We will also continue to expand our efforts in closing the health equity gap through various projects, scientific initiatives, additional public health campaigns, and stakeholder outreach. We will also continue to strengthen our ties with communities through the most effective and innovative platforms.
This includes 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 diverse 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.
It really comes down to our continued focus and commitment 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.
>> Anand Shah: Admiral Araojo, thank you for taking the time to join us this week on FDA Insight. You’ve provided a lot of great information about the work you’re doing in minority health. I want to especially thank you for all that you’re doing to support the public health of a very diverse America.
>> RADM Araojo: Thank you again for having me. I had a great time.
>> Anand Shah: And thank you to our audience for coming back to listen every week. As always, we’ll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow.
We hope you enjoyed this episode of FDA Insight. Please subscribe to the show on your favorite podcast app such as Apple Podcasts, Google Podcasts, Spotify, and Pandora. Thanks for listening!
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