It’s no secret that President Trump, his Cabinet, and other executive branch leaders are prioritizing deregulatory activities over more historical federal governance approaches. Indeed, one of President Trump’s earliest executive orders – issued on January 31, 2025 – is entitled “Unleashing Prosperity Through Deregulation” and states that for each new regulation issued, at least ten prior regulations must be identified for repeal (and it defines the term “regulation” broadly to include memoranda, guidance documents, and policy statements, among others). In addition to this new 10-for-1 directive, on February 19, 2025, President Trump issued executive order 14219, “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” (EO 14219). The president’s order directs all executive agency heads, in coordination with the Director of the Office of Management and Budget (OMB) and its Department of Government Efficiency (DOGE) Team Lead, to review all existing regulations for “consistency with law and Administration policy” and, within 60 days, to identify regulations that fall under the following categories:
- regulations that are unconstitutional and those that raise serious constitutional difficulties, such as exceeding the scope of power vested in the federal government by the Constitution;
- regulations based on unlawful delegations of legislative power;
- regulations based on anything other than the best reading of the underlying statutory authority or prohibition;
- regulations that implicate matters of social, political, or economic significance that are not authorized by clear statutory authority;
- regulations that impose significant costs upon private parties that are not outweighed by public benefits;
- regulations that harm the national interest by significantly and unjustifiably impeding technological innovation, infrastructure development, disaster response, inflation reduction, research and development, economic development, energy production, land use, and foreign policy objectives; and
- regulations that impose undue burdens on small businesses and impede private enterprise and entrepreneurship.
The 60-day period granted to agency heads under EO 14219 ended on April 19, 2025. Just prior to the deadline for responsive agency submissions to the White House, on April 11, 2025, OMB also published a notice styled as “Request for Information: Deregulation,” which seeks comments from the broader public on “regulations that are unnecessary, unlawful, unduly burdensome, or unsound.” This brief public Request for Information (RFI) from OMB asks commentators specifically to identify “regulations that stifle American businesses and American ingenuity.” The open-ended RFI could reasonably garner comments on regulations across a multitude of industries, including the health care, clinical research, and life sciences sectors. Comments are due to OMB no later than May 12, 2025, and should be submitted via Regulations.gov (Docket ID OMB-2025-0003) with information on the rule’s background and the submitter’s rationale for proposing its rescission.
Also on April 11, the Centers for Medicare & Medicaid Services (CMS) published its own request for information pursuant to its deregulatory activities under EO 14219. CMS is asking “healthcare providers, researchers, stakeholders, health and drug plans, and other members of the public” to submit feedback on a diverse array of topics. Topics of interest include how to streamline regulatory requirements; whether there are opportunities to reduce the administrative burden of reporting and documentation; and whether duplicative requirements can be identified and reduced. CMS also requests that responsive public comments include, where practical “data, examples, narrative anecdotes, and recommended actions.”
In parallel to the ongoing and wide-ranging processes of identifying federal rules and regulations that may be ripe for revocation, the Trump Administration has signaled in multiple forums that it intends to bypass procedural requirements created by Congress with the Administrative Procedure Act (APA). Most conspicuously, on April 9, 2025, President Trump issued a Memorandum to the Heads of Executive Departments and Agencies on the subject of “Directing the Repeal of Unlawful Regulations.” The memo directs executive branch leaders to identify categories of unlawful and potentially unlawful regulations following their completion of the 60-day review period ordered in February via EO 14219 and to immediately repeal any regulation that “clearly exceeds the agency’s statutory authority or is otherwise unlawful.”
In directing his administration regarding what regulations may be unlawful, President Trump cites a slew of recent Supreme Court decisions that he characterizes as having “recognized appropriate constitutional boundaries on the power of unelected bureaucrats and that restore checks on unlawful agency actions,” such as last year’s Loper Bright v. Raimondo. The memo continues to state that: “In effectuating repeals of facially unlawful regulations, agency heads shall finalize rules without notice and comment, where doing so is consistent with the ‘good cause’ exception in the [APA]…that allows agencies to dispense with notice-and-comment rulemaking” in certain situations.
Whether such regulatory changes can be implemented without following the typical rulemaking process is very likely to be subject to litigation initiated by stakeholders who prefer the regulations in question stay in place, as the APA’s “good cause” exception has not been used to support widespread deregulatory activities such as this one, and existing case law does not appear to support the President’s expansive view of the exception’s applicability. It’s also worth noting that the Department of Health and Human Services (HHS) separately published a notice on March 3, 2025 rescinding a long-standing departmental policy that directed HHS to use the APA’s good cause exception “sparingly.” This HHS policy shift makes it more likely that the department may seek to make significant regulatory changes – whether promulgating new rules or revoking existing rules – without engaging in public notice-and-comment processes. Stakeholders should continue to closely monitor HHS and agencies within its purview (e.g., CMS) for actions that would affect their rights and that may not comply with the statutory mandates of the APA.