Office of Minority Health and Health Equity (OMHHE) Strategic Priorities Public Docket
The National Health Council (NHC) appreciates the opportunity to provide comments as the Food and Drug Administration’s (FDA’s) establishes its Office of Minority Health and Health Equity (OMHHE) Strategic Priorities public docket. The OMHHE outreach, communication, research, and collaboration programs have an important role in reducing health disparities that disproportionately affect racial and ethnic minority, underrepresented, and underserved populations. We agree that to achieve OMHHE’s goal of health equity our health care system must identify and address the multiple, complex factors driving health disparities.
Created by and for patient organizations 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, sustainable health care. Made up of more than 140 national health- related organizations and businesses, the NHC’s core membership includes the nation’s leading patient organizations. Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses representing biopharmaceutical, device, diagnostic, generic, and payer organizations.
Overarching Comments
FDA should work across the agency to address disparities of all underrepresented, underserved, and/or disadvantaged populations.
While we wholeheartedly support FDA’s focus on addressing racial and ethnic disparities, we believe that the FDA should also work thought the agency to identify the unique needs of and address disparities faced by all underrepresented, underserved, and/or disadvantaged populations, including those with disabilities and complex health needs. While the OMHHE can serve an important role, it is important that its focus be incorporated throughout the culture and operations of the agency. An emphasis on bringing issues affecting underrepresented populations to the forefront of the FDA and ensuring that there is sufficient expertise on the topic, should exist in all aspects of the FDA, ranging from the Commissioner’s office to each review division. This could be a comparable process to the FDA’s current approach to rare disease, where Rare Disease Program staff are embedded in each review division.
As a part of these efforts, the FDA should consider a broader focus on underserved populations. For example, the agency could consider a definition that is consistent with the one used by the Centers for Medicare & Medicaid Services’ (CMS’) Office of Minority Health which “offers a comprehensive source of information on eliminating health disparities and improving the health of all minority populations, like racial and ethnic minorities, people with disabilities, members of the lesbian, gay, bisexual, and transgender community, and rural populations.”1
The NHC particularly asks FDA to include complex populations in its emphasis on underserved and underrepresented populations. As FDA noted in its draft guidance on Enhancing the Diversity of Clinical Trial Populations, “failure to include complex participants in a development program may lead to a failure to discover important safety information about use of the investigational drug in patients who will take the drug after approval.” For many individuals, the ability to take part in the drug-development process is an empowering step that aligns with their health care goals and could allow earlier access to treatments to significantly improve health outcomes. A focus on this population, not only in clinical trials, can help ensure that the FDA considers how medical products work in a real-world setting.
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Office of Minority Health and Health Equity (OMHHE) Strategic Priorities Public Docket
02/28/2020
The National Health Council (NHC) appreciates the opportunity to provide comments as the Food and Drug Administration’s (FDA’s) establishes its Office of Minority Health and Health Equity (OMHHE) Strategic Priorities public docket. The OMHHE outreach, communication, research, and collaboration programs have an important role in reducing health disparities that disproportionately affect racial and ethnic minority, underrepresented, and underserved populations. We agree that to achieve OMHHE’s goal of health equity our health care system must identify and address the multiple, complex factors driving health disparities.
Created by and for patient organizations 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, sustainable health care. Made up of more than 140 national health- related organizations and businesses, the NHC’s core membership includes the nation’s leading patient organizations. Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses representing biopharmaceutical, device, diagnostic, generic, and payer organizations.
Overarching Comments
FDA should work across the agency to address disparities of all underrepresented, underserved, and/or disadvantaged populations.
While we wholeheartedly support FDA’s focus on addressing racial and ethnic disparities, we believe that the FDA should also work thought the agency to identify the unique needs of and address disparities faced by all underrepresented, underserved, and/or disadvantaged populations, including those with disabilities and complex health needs. While the OMHHE can serve an important role, it is important that its focus be incorporated throughout the culture and operations of the agency. An emphasis on bringing issues affecting underrepresented populations to the forefront of the FDA and ensuring that there is sufficient expertise on the topic, should exist in all aspects of the FDA, ranging from the Commissioner’s office to each review division. This could be a comparable process to the FDA’s current approach to rare disease, where Rare Disease Program staff are embedded in each review division.
As a part of these efforts, the FDA should consider a broader focus on underserved populations. For example, the agency could consider a definition that is consistent with the one used by the Centers for Medicare & Medicaid Services’ (CMS’) Office of Minority Health which “offers a comprehensive source of information on eliminating health disparities and improving the health of all minority populations, like racial and ethnic minorities, people with disabilities, members of the lesbian, gay, bisexual, and transgender community, and rural populations.”1
The NHC particularly asks FDA to include complex populations in its emphasis on underserved and underrepresented populations. As FDA noted in its draft guidance on Enhancing the Diversity of Clinical Trial Populations, “failure to include complex participants in a development program may lead to a failure to discover important safety information about use of the investigational drug in patients who will take the drug after approval.” For many individuals, the ability to take part in the drug-development process is an empowering step that aligns with their health care goals and could allow earlier access to treatments to significantly improve health outcomes. A focus on this population, not only in clinical trials, can help ensure that the FDA considers how medical products work in a real-world setting.
Read More