FDA pulls diversity action plan guidance, other diversity programs after executive order

Following the spate of executive orders issued in the first days of the Trump administration, the FDA has quietly pulled several of its diversity-related initiatives and policies, including the high-profile Diversity Action Plan (DAP) guidance document, the Oncology Center of Excellence (OCE) Project Equity, and a new guidance from the device center on “sex and gender” differences.

With a new administration, FDA removed its Diversity Action Plan guidance

• 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, entitled “ 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….”
• FDA’s Diversity Action Plan (DAP) guidance appears to now be a casualty of the order. As of Jan. 23, that draft guidance (issued in June 2024, replacing a 2022 draft version) has been removed from the FDA’s guidance database. The guidance document’s landing page, which is still up as of the time of publication of this analysis, now leads only to the Federal Register notice of its publication. The document is (as of now) still available on the associated docket; notably, when a guidance is formally withdrawn the version in the docket on regulations.gov will usually indicate that, making the document as “withdrawn” in the folder. For now, the DAP guidance is not marked as withdrawn, and the FDA has not commented on its removal from the online database, nor has it announced the guidance document’s formal withdrawal.
• What’s next? The future of the DAP guidance is unclear. As AgencyIQ has previously discussed, the FDA issued the DAP guidance to fulfill a statutory requirement. Under provisions in the 2022 consolidated omnibus bill known as the Food and Drug Omnibus Reform Act (FDORA), Congress granted FDA the legal authority to require diversity plans from medical product sponsors and tasked the agency with issuing new guidance to implement these provisions of the law. Per the statute, FDA was supposed to issue a final guidance implementing the DAP requirements by around June 2025, nine months after the close of the comment period on the draft version.
• While the issuance of the guidance is technically required, it’s not entirely clear if the 119^th Congress would enforce this. Typically when the FDA bypasses or does not meet a statutory direction from Congress, lawmakers will reach out to the agency to hold them to account – see, for example, this 2024 letter to then-Commissioner ROBERT CALIFF from Democratic Members of House Committee on Energy and Commerce (E&C) citing concern about the delay in issuing the draft version of the DAP guidance, which was required by legislation to be issued in December 2023, but not published until June 2024. It’s not yet clear if the current Congress will call on the agency to meet the FDORA requirement to issue the DAP guidance, or hold the agency accountable in some fashion, given the new administration’s prohibition on issuing policy related to “equity action plans” – or, in this case, DAPs.
• Does the agency have the authority to require DAPs without a final guidance? No, it doesn’t. FDORA added sections 505(z) and 520(g) of the Federal Food, Drug and Cosmetic Act (FD&C) Act, which remain in place. Those sections of the law state, respectively, that “the sponsor of such [drug] shall submit to the Secretary of a diversity action plan” and “the sponsor of a device [for which an Investigational Device Exemption] is required shall submit to the Secretary in such an application a diversity action plan for clinical studies of the device” as well as “the sponsor of a device for which submission of an [IDE] is not required” but for which a clinical study is being conducted.
• However, the FDORA provision includes a specific effective date: While both statutory citations now incorporated into the FD&C Act remain in place, the FDORA language specifically states that DAPs should be submitted “in the form and manner specified in guidance,” and that the effective date of the provisions (“sections 505(z) and 520(g)(9)… as added by section 3601” of FDORA) is tied to the publication of that guidance. Per FDORA, those sections of the law “shall apply only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under this section.”
• In short: If there’s no final guidance, FDA’s authority to require DAPs never becomes effective. While the policy remains on the books within the text of the statute, meaning that FDA could pick up a DAP guidance at its discretion in the future and the provision would go into effect at that time, there’s no clear path forward for the policies – or the companies preparing to implement it – at this time.

What else has been removed from FDA’s projects and programs? Project Equity and guidance on sex and gender differences

• The Oncology Center of Excellence (OCE) Project Equity has also been removed from the FDA’s website. OCE’s Project Equity was established in 2020 to help “improve access to clinical trials of oncology medical products for populations that have been historically underrepresented in clinical research, such as racial and ethnic minorities, individuals who live in rural areas, sexual and gender minorities, and individuals with economic, linguistic, or cultural barriers to healthcare services,” and was the original lead author of the FDA’s 2022 draft guidance on what became DAPs. However, Project Equity’s presence has now been deleted from the web, with its link now returning a “Page Not Found” error message (see an archived version of Project Equity here). This is the only one of OCE’s project/program pages that has been removed. Other projects/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) remain online. The Project Silver hyperlink on the OCE project homepage also returns an error, but it has done so since OCE announced the Cancer in Older Adults Program in September 2024.
• What else has FDA removed? In early January 2025, FDA released two new draft guidance documents on sex-based differences in medical product research – one specifically on sex-based differences for all regulated medical products and the other from the Center for Devices and Radiological Health (CDRH) that covered sex and gender in device development. While the first draft guidance remains in place, the CDRH draft guidance on “sex and gender” has been removed from the FDA’s database entirely; CDRH’s 2014 final guidance on sex differences remains in place as well.
• This specific removal is likely due to another EO from the Trump administration. As AgencyIQ previously discussed, this new EO from the Trump administration “recognize[s] two sexes, male and female” at the federal level. The EO went on to specify that the U.S. federal government recognizes “the concept of ‘gender identity’” as separate from sex, but “that does not provide a meaningful basis for identification and cannot be recognized as a replacement for sex.” The EO directed all agencies to “use the term ‘sex’ and not ‘gender’ in all applicable Federal policies and documents,” and sets formal definitions of “male” and “female.”
• This means that while the FDA’s guidance documents on sex-based differences (as a biological variable) may remain in place, the CDRH draft guidance on sex and gender would go against the directions in the EO.
• It’s too early to tell, but representation policies from the Trump administration FDA may feature an enhanced effort to focus on representation of other categorical or demographic groups, including older/younger populations and female participants.

To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).

Key Documents and Dates

• Diversity Action Plan draft guidance home page
• DAP regulations.gov docket
• AgencyIQ Analysis: What’s in President Trump’s first-day documents drop for FDA?