By: Jennifer Dexter, Assistant Vice President, Policy

Last week, two long-awaited actions affecting health equity were released by the Biden Administration. The NHC applauds this continued focus and activity on health equity and will join with our members and other patient groups in providing input and guidance.

The first event was the release on April 14 of Equity Action Plans from over 90 federal agencies. These were the result of an Executive Order President Biden issued on his first day in office calling on all federal agencies to outline their specific role in advancing equity. While this activity is government-wide, the NHC is particularly focused on the work of the Department of Health and Human Services (HHS). You can read HHS’ Equity Action Plan here. The HHS plan focuses on five key areas:

1. Civil Rights Protections and Language Access
2. Acquisitions
3. Grants
4. Capacity Building
5. Maternal Mortality

The second item was the release on April 14 of guidance from the Food and Drug Administration on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry. The purpose of this guidance is to provide recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan to enroll representative numbers of participants from underrepresented racial and ethnic populations in clinical trials.

Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population.

This guidance follows 2020 FDA guidance on increasing diversity of clinical trials, for which the NHC submitted comments. The NHC called for this guidance as part of our health equity policy recommendations, and we will be working with our members to develop comments on the proposed guidance. Comments are due June 16.