FDA begins restoring some documents following court order

The U.S. District Court for the District of Columbia ruled Feb. 11 that the FDA and Centers for Disease Control and Prevention’s (CDC) recent actions to remove content from their websites violated federal law and issued a temporary restraining order to the agencies to halt their removal of webpages. On Feb. 12, the FDA began restoring some previously deleted resources, including the 2024 Diversity Action Plan (DAP) draft guidance.

The court case followed removal of agency webpages

• Quick introduction: On Jan. 20, President DONALD J. TRUMP issued a series of executive orders (EOs) that led to the removal of certain documents and resources from the health agencies. These include, EO 14151, “Ending Radical and Wasteful Government DEI Programs and Preferencing,” which directed agencies to terminate programs related to diversity, equity and inclusion (DEI) and eliminate any DEI “action plans.”. Under the directives in this order, the FDA removed guidance on Diversity Action Plans (DAPs), as well as other resources and webpages on its diversity-related projects and programs. The president also issued EO 14168, which “recognize[s] two sexes, male and female” at the federal level and directs agencies to “use the term ‘sex’ and not ‘gender’ in all applicable Federal policies and documents.” Following this EO, the FDA removed a January 2025 draft guidance on sex- and gender-based differences in device development, which had just been issued by the Center for Devices and Radiological Health (CDRH), and has been making other updates to its dossier of guidance documents to align with the directives in the EO. [See AgencyIQ’s explainer on this issue here.]
• Doctors for America (DFA), an advocacy group for clinical providers, filed a suit in the U.S. District Court for the District of Columbia against the White House Office of Personnel Management (OPM) on Feb. 4, citing harm to clinicians and patient care from the removal of online resources from both the FDA and the Centers for Disease Control and Prevention (CDC). The complaint cited the implementation of EO 14168 by OPM, which included a memo to agencies directing them to “review all agency programs, contracts, and grants, and terminate any that promote or inculcate gender ideology,” “take down all outward facing media (websites, social media accounts, etc.) that inculcate or promote gender ideology,” “review all agency forms that require entry of an individual’s sex and ensure that all list male or female only, and not gender identity” to substitute the term “sex” for “gender” and “ensure that all applicable agency policies and documents, including forms, use the term ‘sex’ and not ‘gender’ – among other activities. The FDA has been conducting a sweep of its guidance documents to update the terminology in alignment with the EO.
• DFA sought a temporary restraining order that would bar the agencies from removing more information from their online databases and require them to restore the removed content. Specifically, the group cited “numerous webpages and datasets” that clinicians use in their practice, including “treatment guidance, datasets, and other information that healthcare providers used to provide treatment, conduct research, and inform public health responses on subjects such as youth risk behaviors, adolescent and school health, social vulnerability and environmental justice, HIV, contraception, assisted reproductive technologies, and how to develop clinical trials, including improving the inclusion of women and underrepresented populations.”
• The legal argument was that the FDA and CDC violated the Administrative Procedures Act (APA) and, in some cases, the Paperwork Reduction Act (PRA). These laws set federal standards for regular process in policymaking. As AgencyIQ has previously discussed, the APA is the cornerstone of federal regulatory process, setting the rules for how rulemaking is to take place. The APA’s scope includes formal rulemaking, informal rulemaking and the adjudication of violations. In general, the APA sets requirements for how rules are published to ensure those beholden to those rules are aware (or could reasonably be made aware) of a new rule, and of the obligations the rule imposes. To fulfill this principle, the APA requires either that a rule be published in the Federal Register – the official journal of the federal government – or alternatively, that a government agency provide personal service or “actual notice” to “persons subject” to the rulemaking. Because the APA prescribes rulemaking requirements, it also means that failures by regulators to follow these process standards can result in an action being found illegal.
• DFA argued that the removal of federal resources was “arbitrary and capricious in violation of the APA,” namely that the actions were illegal because “the agencies did not provide any notice prior to the removals” and “irreparably harmed” the clinicians who relied on these resources and their patients.
• U.S. District Judge JOHN BATES agreed with DFA’s contention that the removal of the webpages constituted final agency actions, which meant that the APA does apply. Bates determined that the removal of CDC and FDA webpages violated the APA because it did not conform to APA practices for policymaking. Further, Bates noted that the PRA also requires agencies to “‘provide adequate notice when initiating, substantially modifying, or terminating significant information dissemination products,’ which HHS defines to include electronic documents and webpages.” In the decision, Bates noted that this provision “seems to require an agency to maintain an important webpage for the period between when the agency issues a notice of termination and when it actually terminates the webpage,” and that therefore the agencies violated the PRA as well. Bates also asserted that “the balance of equities and the public interest strongly favor” DFA’s argument that public health could be harmed by the agencies’ actions.
• In a statement to AgencyIQ, DFA board President CHRISTINE PETRIN wrote: “Today’s decision to restore access to vital public health information is a victory for physicians, researchers, and the patients we serve. When these webpages went dark, providers across the country experienced firsthand the challenges of practicing medicine without access to crucial clinical data—challenges that, in some cases, led to delays in providing evidence-based care. For the safety of our patients and communities, we applaud this step toward transparency and remain committed to ensuring that these resources remain permanently available. Access to accurate, up-to-date public health information is essential to delivering high-quality care and protecting public health.”

The FDA has already begun restoring documents

• In short, the temporary restraining order directed FDA and CDC to stop deleting web content and restore the pages they had deleted. The DFA suit focuses on public health resources, such as webpages about treatment guidelines for sexually transmitted infections, but the pages removed also include content previously flagged by AgencyIQ related to clinical trial diversity, such as Project Equity.
• On Feb. 12, the FDA restored the 2024 Diversity Action Plan (DAP) guidance document, which was removed from the agency’s online guidance repository in January. Other related documents, including the 2024 draft guidance on the Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products, which had also been removed from the guidance repository, are also back online. While 2020 final guidance on enhancing clinical trial diversity has not yet been republished as of the time of publication of this analysis, it seems likely that it will be back up shortly. The webpage for the Oncology Center of Excellence’s (OCE) Project Equity, as well as the webpage for the FDA’s Office of Minority Health, have similarly not yet been restored as of publication.
• What about all of the guidance documents that have been subtly changed? As AgencyIQ has discussed, FDA wasn’t just removing documents and resources, it was also removing, updating, and then republishing documents without notice. It isn’t entirely clear whether this falls within the scope of the temporary restraining order stemming from DFA’s lawsuit or whether additional remedies need to be sought to clarify the FDA’s process.
• However, some guidance documents that were revised have now been restored to their original versions. FDA’s 2025 draft guidance on conducting assessments of sex-based differences in medical product research was previously pulled from the online repository and then re-uploaded with slightly different content – the FDA had removed any reference to “gender” in alignment with EO 14168 (using “sex” instead of “gender”). That document has now (as of Feb. 12) been restored to its original January 2025 version – including separate definitions for “sex” as a biological construct and “gender” as a “multidimensional construct.” The DAP guidance was also restored in its original version, with discussions on “gender” as well.
• Not all guidance documents have been restored just yet. There is no (public) running list of the documents that had been revised under the directives in EO 14168, but industry and researchers had noticed documents going briefly missing before being reinstated with slightly different wording. While the sex-based differences draft guidance has been restored to its original version, other documents appear not to have been changed back just yet. For example, guidance on marketing submissions for artificial intelligence devices using predetermined change control plans (PCCPs), guidances on the use of electronic health data and the use of registry data, and guidance on clinical decision support (CDS) software all remain in an altered format without the term “gender.”

What’s next?

• As AgencyIQ has previously discussed, APA violations are one of the key arguments that can be deployed against agencies, especially the FDA. The bypassing of regular regulatory processes in the first days of the second Trump administration has been particularly stark, but the typical remedies that the life sciences industry and other stakeholders (including clinician groups) can undertake continue to apply, according to Bates’ decision. If it stands, this decision could set a standard for other entities seeking to reinstate documents that have been removed from the FDA website or entities seeking more clarity from regulators when these types of changes are made.
• In short: There are a lot of moving pieces. So far, agencies including the FDA have not been transparent about the changes they’re making to implement the EOs quickly, but lawsuits like this from DFA could provide more information and potentially lead to reinstating documents or resources that have gone missing. Still, interested parties need to keep a close eye out for additional changes or how reinstated webpages or documents may vary from their original versions.
• For now, industry should potentially expect documents to go briefly missing yet again – this time to re-add references to “gender.” Further, they might notice other missing resources, such as Project Equity, begin to reappear in the coming days and weeks.

Featuring previous research by Alexander Gaffney.

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) or Alexander Gaffney ( agaffney@agencyiq.com).

Key Documents and Dates

• Doctors For America v. the Office of Personnel Management et al., issued Feb. 11, 2025