The AAMC submitted comments on Feb. 25 to the Food and Drug Administration (FDA) on the development of strategic priorities for the Office of Minority Health and Health Equity (OMHHE).
The OMHHE advises the FDA on issues relating to the health of underrepresented and underserved populations. The OMHHE currently focuses on research and collaboration between the FDA and academic institutions and on culturally competent patient outreach and communication.
The FDA requested comments on the areas and types of engagement the OMHHE should prioritize in the coming years as well as potential implementation mechanisms.
The AAMC applauded the FDA’s efforts to address inequities in access to information and FDA-approved drugs and devices. The AAMC encouraged the FDA to:
- Collaborate with the FDA’s Office of Patient Affairs to use patient experience data to design studies and define research objectives that increase trust between researchers, patients, and caregivers.
- Build effective and appropriate communication channels via patient and community partnerships — especially with local, regional, and national minority organizations — and evaluate any new communication efforts to measure their effectiveness.
- Align research frameworks, metrics, and evaluation strategies with Offices of Minority Health across the Department of Health and Human Services and as part of the Federal Interagency Health Equity Team.
- Consider incorporating social factor data that may impact clinical trial results into FDA science to better understand how social influences impact treatment outcomes.