FDA Guidance On Standardizing Diversity And Inclusion Terminology And Collection

By Deborah L. Livornese, Hyman, Phelps & McNamara

Last week, the FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. As described in a blog post here, the Food and Drug Omnibus Reform Act (FDORA) enacted at the end of 2022 adds new statutory obligations related to the development of diversity action plans by sponsors of certain device and drug clinical trials, and requires FDA to issue guidance. The FDA specifically notes that the draft guidance does not address diversity action plans or the appropriate population for a clinical study, while also reminding readers that sponsors should enroll participants who reflect the population that will use the medical product if approved. Nevertheless, the draft guidance represents another step forward in the journey toward increasing diversity in clinical trials and representation of the real world populations who will use the products in studies.

The new draft guidance focuses on standardizing the approach and terminology used in gathering information about race and ethnicity to ensure that information is collected and reported consistently in submissions to the FDA. In keeping with the goal of standardization, the draft guidance is issued by a long list of agency level offices (including the Offices of the Commissioner, Minority Health and Health Equity, and Women’s Health, among others) and all three human medical product centers (CDER, CBER, and CDRH), as well as the Oncology Center of Excellence.

Specifically, the draft guidance recommends that the minimum choices offered for ethnicity include “Hispanic or Latino” and “Not Hispanic or Latino.” Similarly, for race, the draft guidance recommends the following minimum choices with direction to the reader to select one or more:

• American Indian or Alaska Native
• Asian
• Black or African American
• Native Hawaiian or Other Pacific Islander
• White

The FDA states that it recognizes that the categories were developed in the United States and may not be adequate to describe racial and ethnic groups in other countries. If expanded choices are desirable, the FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance.

The draft guidance emphasizes that the study team should not answer the questions based on observation or even on existing medical records. Instead, the information should be self-reported or, if that is not possible, provided by a first-degree relative or knowledgeable representative.

Notably, the FDA recognizes that Office of Management and Budget (OMB) Policy Directive 15 (issued in 1997 and currently being reviewed for update), which provides a minimum standard for collecting and presenting data on race and ethnicity by federal agencies states that recommended race and ethnicity categories “were not anthropologically or scientifically based designations, but ... describe the sociocultural construct of our society.” The FDA states, however, that collecting data on race and ethnicity is critical to identifying population-specific signals, noting that differences in response to medical products while uncommon may be attributable to intrinsic factors (e.g., genetics, metabolism, skin pigmentation) or extrinsic factors (e.g., diet, socioeconomic status, culture). The FDA states that the term clinical studies refers in the draft guidance to both interventional studies and observational studies though some recommendations are relevant only to interventional studies.

When finalized, the draft guidance will take the place of the 2016 guidance Collection of Race and Ethnicity Data in Clinical Trials. The comment period ends on April 29, 2024.

A version of this article was published first on Hyman, Phelps & McNamara’s FDA Law Blog. It is republished here with permission.

About The Author:

Deborah Livornese has extensive experience in a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on regulatory requirements and strategies related to obtaining FDA approval and other paths to market, as well as on post-marketing regulatory requirements. Ms. Livornese also assists clients in connection with commercial transactions and public offerings by conducting FDA regulatory due diligence on behalf of regulated companies and potential investors or purchasers.

Prior to joining Hyman, Phelps & McNamara, Ms. Livornese spent seven years in the Office of Regulatory Policy in FDA’s Center for Drug Evaluation and Research. As a senior regulatory counsel at FDA, she was involved in a wide variety of policy issues in the areas of drug approvals and withdrawals, the regulation of unapproved and over-the-counter drugs, and opioid drugs, and user fee programs.