Trump reintroduces revamped deregulatory executive order: One in, 10 out, and a bigger role for the Unified Agenda

Life Sciences | By Laura DiAngelo, MPH

Feb. 03, 2025

During his first term, President DONALD TRUMP issued an executive order directing agencies to identify two regulations to be repealed for every new regulation. In early February 2025, the second Trump administration issued a new executive order reinstating and significantly expanding that policy, directing agencies to identify 10 policy documents to repeal for every new one – including guidance documents. Further, the order sets up a new system for budgeting for regulation going forward.

The expanded executive order calls for significant cuts to the dossier of policy document at the federal level

  • Quick background: President DONALD TRUMP’s previous stance on deregulation. During his first term in office, Trump issued Executive Order (EO) 13771, which stated, “Unless prohibited by law, whenever an executive department or agency (agency) publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least two existing regulations to be repealed,” and that unless required by law, “no regulation shall be issued by an agency if it was not included on the most recent version or update of the published Unified Regulatory Agenda” or was previously approved in advance. Less than a month later, he followed up with another executive order directing each agency to create a Regulatory Reform Task Force to “ focus on eliminating costly and unnecessary regulations.”
  • However, their impact was limited: A GAO report issued in September 2021 concluded that these two EOs “did not substantially change selected agencies’ processes or procedures,” at least for the five agencies it evaluated. In the campaign for his second presidency, Trump touted an expanded version of the original EO, floating the idea of cutting 10 existing regulations for every new rule promulgated.
  • On Jan. 31, 2025, Trump announced a new EO to implement the 10-to-1 deregulatory policy. The White House Fact Sheet for the EO states that “the Order requires that whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed.” Further, “it requires that for fiscal year 2025, the total incremental cost of all new regulations, including repealed regulations, be significantly less than zero.”
  • The actual EO is not posted on either the White House website or in the Federal Register (as of time of publication). However, the text of the EO is available via POLITICO Pro.
  • The policy is generally as it sounds: For every one regulation in, agencies will need to identify 10 to eliminate. “Unless prohibited by law, whenever an executive department or agency (agency) publicly proposes for notice and comment or otherwise promulgates a new regulation, it shall identify at least 10 existing regulations to be repealed.”
  • What counts as a “regulation” under the EO? It’s an extensive list. The EO defines “regulation” or “rule” to include regulatory documents far beyond formal notice-and-comment rulemaking. It applies these terms to “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency, including, without limitation, regulations, rules, memoranda, administrative orders, guidance documents, policy statements, and interagency agreements, regardless of whether the same were enacted through the processes in the Administrative Procedure Act” (emphasis added). There are a few exceptions, including regulations related to the military or national security, regulations related to “agency organization, management, or personnel” or “any other specific regulation or category of regulations exempted by the Director” of the Office of Management and Budget (OMB). This means that going forward, the director of OMB will have broad leeway to apply this policy to specific agencies. For reference, the 2017 EO defined “regulation” or “rule” to mean “an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.” In short: This policy applies far beyond the original 2017 EO in terms of applicability.
  • The EO imposes additional constraints to policymaking, which are related to regulatory costs. Starting this federal fiscal year (2025), the EO directs agencies “to ensure that the total incremental cost of all new regulations, including repealed regulations, being finalized this year, shall be significantly less than zero … unless otherwise required by law or instructions from the Director” of OMB. In general, the EO expects that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.”
  • How will this work? TBD. The OMB director is tasked with defining what this looks like in the office’s own guidance, which would include both definitions of what offsets look like and how the determinations are made, and account for “circumstances that might justify individual waivers of the requirements of this section.” Further, OMB’s guidance should “consider phasing in and updating these requirements.” It’s not clear whether OMB will have to rescind 10 guidance documents to issue this one, as it’s not listed in an exempted category.
  • And another thing: Going forward, the Unified Agenda will be a bit more binding. According to the EO, starting in fiscal year 2026: “Unless otherwise required by law, no regulation shall be issued by an agency if it was not included in the most recent version or update of the published Unified Regulatory Agenda … unless the issuance of such regulation was approved in advance in writing by the Director” of OMB. Currently, FDA has 52 life sciences-related documents on its Fall 2024 Unified Agenda (this is latest version of the biannual federal rulemaking agenda). Further, under the EO, the agency regulatory plans that are submitted to OMB (which compiles the Unified Agenda) will need to include a plan to offset the costs of their planned regulations or “provide the agency’s best approximation of the total costs or savings associated with each new regulation or repealed regulation.” The OMB director is tasked with coming up with a sort of regulatory budget: “identify[ing] to agencies a total amount of incremental costs that will be allowed for each agency in issuing new regulations and repealing regulations for each fiscal year after fiscal year 2025,” and agencies will need to stay within their OMB-defined regulatory budget.

Analysis and What’s Next

  • This is likely to have significant impact on the FDA. As AgencyIQ has previously discussed, the one-in, 10-out policy is likely to be a significant issue for the regulator. The FDA does maintain regulations on its books covering specific standards (FDA’s now-eliminated standard of identity for frozen cherry pie comes to mind), there is a finite number of these and other regulations that can easily be eliminated without disrupting standards intended to protect consumers or aid in the development of new products.
  • The definition of “regulation” here is also extensive. As described above, the EO includes not just regulations but also documents such as guidances, memos and even policy statements. Starting in 2026, the agency would further be constrained to only issue documents included on the Unified Agenda. FDA’s guidance agendas out of FDA go significantly beyond the Unified Agenda. Per AgencyIQ’s recent accounting, there are 176 life sciences-related guidance documents currently under development or in the pipeline at FDA. The 52 life sciences documents on the Unified Agenda are largely composed of rules FDA is working on as defined in the Administrative Procedures Act (APA). The new EO bypasses the definition of “regulation” under the APA and even expands beyond the original 2017 EO from the first Trump administration.
  • The rule of 10. Taking the EO at face value, if the 176 life sciences guidance documents get published, that could mean 1,760 other FDA “regulations,” as defined in the EO, would need to be deleted. Considering that the agency has 2,767 guidance documents, this would be a significant reduction.
  • What does this mean for draft guidance? It’s not clear whether the issuance of draft guidance would trigger the need for a repeal of 10 other documents or if this only applies to final guidance documents. This will likely need to be further explained in the forthcoming guidance from OMB.
  • What exactly will happen with the FDA’s guidance agendas if the Unified Agenda becomes the agenda of the federal government, with the agency not allowed to publish documents (including guidance, memos and policy statements) that are not on the Unified Agenda remains to be seen. Further, the FDA’s regulatory budget would be set by OMB going forward, which could constrain the agency’s ability to plan documents for publication.
  • Could guidance documents get longer? Theoretically, it is possible that FDA would seek to reduce the overall number of guidance documents it issues by combining multiple documents on its agendas into one larger document. For example, two separate guidance documents on FDA’s Office of the Chief Medical Officer (OCMO) guidance agenda on the orphan drug program (one on formatting/assembling designation requests and another on an overview of the program itself) could be collated into one document, or just added to existing orphan drug policies. However, this will likely depend on how OMB looks to implement the provisions related to regulatory costs and offsets.
  • The EO is likely to hit some policy topics harder than others. The FDA’s standard practice is to issue individual guidance documents on specific aspects of research programs, including clinical studies and clinical trials. These include individual guidance documents on topics such as eligibility criteria for cancer trials (including individual documents on performance status, washout periods and concomitant medications, and laboratory values). The FDA generally issues individual guidance documents on the various aspects of trials by study design, therapeutic area, and even methods, and clinical trial. In 2024, a dozen guidance documents the agency issued were categorized as “clinical trial” related on its guidance repository, meaning that 120 documents would need to be rescinded for that policymaking cadence to keep up in 2025.
  • What about documents that are required by law, such as the Diversity Action Plan (DAP) guidance? Presumably, the one-in, 10-out rule would still apply to these types of policies unless the OMB director’s implementing guidance specifically carves them out. Still, these documents could be issued even without their inclusion on the Unified Agenda in future years, as they’re directed under law. [See AgencyIQ’s Jan. 30 analysis providing a status check on the diversity policies here.]
  • OMB guidance implementing this EO will provide more information about how, exactly, these policies will work or what industry should expect, including how FDA will be expected to estimate regulatory costs and new and offsetting regulations. However, the EO doesn’t set a specific timeline for the issuance of this guidance for agencies.
  • In short: Wait and see. The new EO is a significantly expanded version of the 2017 EO, both in terms of the types of documents to which the policy will apply and in the requirements (going from one-in, two-out to one-in, 10-out). The actual impact of the EO remains to be seen. While the first version did not have a significant impact on regulatory agencies, the newly expanded version could have more impact on the agencies’ ability to publish documents and, therefore, industry’s ability to understand regulators’ thinking or decision-making criteria. OMB has broad leeway to define terms, make exemptions and set regulatory budgets for agencies going forward, but the office has not yet issued guidance, and it’s not clear when we should expect that.

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).

Key Documents and Dates

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