Status check: What’s going on with FDA’s diversity-related policies
Life Sciences
| By Laura DiAngelo, MPH

Following the new Trump administration’s issuance of several executive orders related to diversity policy, the FDA has been pulling certain documents and deleting websites concerning its diversity-related initiatives – even as the HHS secretary nominee verbally committed to moving certain policies forward. AgencyIQ walks through what’s gone, what’s still up and what’s next.
The first few weeks of the second Trump administration have seen a flurry of activity
- In the first days of his second term as president, DONALD TRUMP signed a flurry of executive orders (EOs). As AgencyIQ discussed in our analysis of those orders and their impact on FDA and life sciences regulatory policy, the EOs covered a broad swath of topics ranging from federal workforce reforms and hiring processes to policy-related matters, as well as revoking many EOs issued by the Biden administration.
- An early EO from this Trump administration focuses on diversity, equity and inclusion (DEI) work, undoing DEI programs and policies implemented by previous administrations. The EO, titled “ Ending Radical and Wasteful Government DEI Programs and Preferencing,” directs “the termination” of DEI/diversity, equity, inclusion and accessibility (DEIA) “mandates, policies, programs, preferences, and activities in the Federal Government, under whatever name they appear.” The EO applies to both staff-oriented programs within agencies, such as trainings and DEI-related positions, but also includes a directive to “terminate… all ‘equity action plans,’ ‘equity’ actions, initiatives, or programs….”
- As AgencyIQ discussed last week, the FDA started to remove some diversity-related content from its websites almost immediately. The most impactful document pulled was the DAP guidance. That guidance remains deleted from the FDA’s guidance repository but is still available on its regulations.gov docket. As AgencyIQ noted at the time, other policies and projects were also pulled, including the webpage for the Oncology Center of Excellence (OCE)’s Project Equity program and the webpage for the FDA’s Office of Minority Health and Health Equity (OMHHE) – both of those links now return a “page not found” message. Further, likely in response to another new EO that “recognize[s] two sexes, male and female” at the federal level and directing agencies to “use the term ‘sex’ and not ‘gender’ in all applicable Federal policies and documents,” another draft guidance on sex- and gender-based differences in device development was also removed from the web.
Checking in on the last week: What’s gone, what’s still up and what we are watching
- In AgencyIQ’s Jan. 23 update, we noted that Project Equity was the only one of OCE’s projects that was removed from the web and that other projects and programs focused on demographic groups, including the Cancer in Older Adults Program (which replaced Project Silver), Project Asha (clinical trial access in India) and Project ASIATICA (“focus and awareness to Asian Americans, Native Hawaiians, and Other Pacific Islander” patients) remained online at that time. While both the Cancer in Older Adults Program and Project Asha are still active, Project ASIATICA has since been removed from the web, with its website link returning the same “page not found” message. Notably, both Project Equity and Project ASIATICA were previously located in a single drop-down menu on OCE’s website – which has now been removed in its entirety.
- One diversity guidance is still up: FDA’s 2020 final guidance on “ Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs” is still online in the FDA’s digital guidance repository. This guidance document has a significantly different scope and applicability from the DAP guidance. While the DAP guidance would set out requirements for a specific component of a submission and set regulatory expectations for population enrollment on the basis of race and ethnicity, the 2020 final guidance on diversity instead provides a series of broad “considerations” for sponsors in designing inclusive trials. These include considerations such as providing reasonable accommodations for disabled participants or non-English speakers, or expanded hours to allow for working people to participate.
- Why is this guidance still up? While it does have “diversity” in the title, this guidance is not focused on diversity on the basis of race and ethnicity; instead, it discusses methods for expanding trial participation more broadly. The EO from the new Trump administration focuses on work undertaken under a Biden-era EO on “racial equity” and directs a termination of federal agencies’ work on “Equity Action Plans.” While the “action plan” portion of the EO does seem to apply to the DAP guidance, it’s not clear that it will apply to other policies that are not focused on race or ethnicity as their primary demographic group of interest, such as the 2020 guidance from FDA.
- The new draft guidance on sex-based differences is also still up. As AgencyIQ discussed at the time, FDA issued two draft guidance documents simultaneously in early January: one focused on assessment of sex-based differences in research on medical products, and the other specifically from CDRH on sex- and gender-based differences. The Center for Devices and Radiological Health (CDRH) guidance has now been pulled down. However, the new sex-based differences draft guidance is still online, as is a 2014 final guidance from CDRH on the same subject.
- AgencyIQ notes that these guidance documents do generally align with the new EO on defining sex, but there are some areas of divergence. The new draft guidance from FDA on sex-based difference evaluation does acknowledge that sex “is usually categorized as female or male, but variations occur,” specifically, differences in sex development or intersex traits. As FDA’s draft guidance notes, “For many drug and device trials, the term gender is used as a substitute for biological sex.” However, the document differentiates between the two, and the recommendations in the guidance focus on sex-based differences. The new EO from the Trump administration likewise defines sex as male or female, and differentiates between sex and gender – but does not include an acknowledgement of sex differences or intersex traits.
- Also still up: FDA guidance from 1993 that uses the term “gender” in what has now been defined as “sex.” Notably, this document will be superseded with the new sex-based differences guidance document when it’s finalized. It’s also accompanied by a guideline for Institutional Review Boards (IRB) published in 1998 that uses the same wording. As these terms (and policies) will be outdated moving forward, it’s likely that it will also be removed when the 1993 guidance is superseded.
Analysis and what’s next
- The future of the DAP guidance remains unclear. As expected during a federal communications freeze, the agency has not commented, acknowledged or explained what is happening with the DAP guidance. While there is still a statutory deadline for its publication, FDA cannot effectuate the DAP requirements without a final guidance, and next steps if the administration blocks or prohibits its publication are unclear.
- In his first confirmation hearing before the Senate Finance Committee, President Trump’s nominee for secretary of HHS, ROBERT F. KENNEDY JR., did verbally commit to finalizing the DAP guidance. In response to questioning from Sen. BEN RAY LUJÁN (D-N.M.), Kennedy did say he would finalize the guidance, but it remains unclear if that will be followed through by the administration.
- How far will the definitions under the DEI EO extend? The FDA does maintain a suite of guidance documents that touch on diversity-related topics that are not specifically “action plan” related. These include, as noted above, the 2020 diversity guidance and guidance documents on topics such as inclusion of specific groups such as older adults and pregnant women; guidance on decentralized trial methods, which have been touted as a way to expand potential participant pools to underserved populations; guidance on designing more inclusive trials via eligibility criteria, such as performance status and lab values; and new draft guidance on geographic representation in multiregional clinical trials. Relatedly, there are several operational guidance documents about the collection of race and ethnicity data, which are focused on the practical expectations for defining and collecting these data, but not specifically on methods of inclusion for specific demographic groups. For now, all of these guidance documents remain in place and have not been removed from the agency’s guidance repository. This raises questions about what will be considered DEI-related policy under the new administration or how and when existing policies may need to be revised or replaced based on administrative priorities.
- For industry, this is a rapidly evolving area. Especially as there are no formal announcements from the FDA at this time, it is difficult to follow what policies are being removed or reversed. The EO directs agencies to halt their DEI programs “within sixty days” of the order (meaning by March 21, 2025), meaning that there could still be additional programs and policies pulled under the EO in the coming weeks. Researchers and companies that are seeking to navigate these policy areas should remain aware of potential changes – and keep an eye out for new (or missing) documents.
To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).
To contact the editor of this item, please email Jason Wermers ( jwermers@agencyiq.com).