Executive Order Directing the Repeal of Unlawful Regulations

Executive Order Directs Agencies to Repeal Unlawful Rules Without Notice and Comment If Possible; Administration Seeks Public’s Views on Regulations That Should Be Eliminated

In an Executive Order issued on April 9, 2025, President Trump has directed federal agencies promptly to repeal any regulation that “clearly exceeds the agency’s statutory authority or is otherwise unlawful” (the “Repeal EO”). This order follows Executive Order 14219 (Ensuring Lawful Governance and Implementing the President’s “Department of Government Efficiency” Deregulatory Initiative) (February 24, 2025), which directed a review to identify regulations that:

• are “unconstitutional … or raise serious constitutional difficulties”;
• are “based on unlawful delegations of legislative power”;
• are based on “anything other than the best reading of the underlying statutory authority or prohibition”;
• “implicate matters of social, political, or economic significance that are not authorized by clear statutory authority”;
• impose “significant costs upon private parties that are not outweighed by public benefits”;
• “imped[e] technological innovation, infrastructure development, disaster response, inflation reduction, research and development, economic development, energy production, land use, and foreign policy objectives”; or
• “impose undue burdens on small business and impede private enterprise and entrepreneurship.”

The Repeal EO cites numerous Supreme Court decisions from the last ten years for which the legal analysis shall be prioritized:

• Loper Bright Enterprises v. Raimondo, 603 U.S. 369 (2024) (overruling Chevron v. NRDC and holding that courts reviewing agency interpretations of statutes should ensure that the agency has followed the best reading, rather than simply a reasonable reading, of the statute);
• West Virginia v. EPA, 597 U.S. 697 (2022) (striking down a rule based on the “major questions” doctrine, under which agency decisions that have significant economic or political consequences must be supported by clear congressional authorization);
• SEC v. Jarkesy, 603 U.S. 109 (2024) (determining that defendants in a civil money penalty case have the right to a jury trial in federal court, rather than a trial before an administrative law judge, when the claim on which the penalty would be based is legal rather than equitable in nature)
• Michigan v. EPA, 576 U.S. 743 (2015) (striking down regulation when EPA refused to consider the cost of the regulation);
• Sackett v. EPA, 598 U.S. 651 (2023) (rejecting EPA’s interpretation of “waters of the United States,” and requiring, among other things, clear congressional authorization of an action that “will significantly alter the balance between federal and state power and the power of the Government over private property”);
• Ohio v. EPA, 603 U.S. 279 (2024) (conducting a detailed record review of argument that EPA failed to adequately explain its final rule);
• Cedar Point Nursery v. Hassid, 594 U.S. 139 (2021) (holding that requiring agricultural employers to permit union organizers access to the employers’ property constitutes a compensable taking of property);
• Students for Fair Admissions v. Harvard, 600 U.S. 181 (2023) (blocking Harvard University’s race-based admissions programs);
• Carson v. Makin, 596 U.S. 767 (2022) (finding that Maine’s prohibition on use of school vouchers at religious schools violated the Free Exercise Clause of the First Amendment); and
• Roman Cath. Diocese of Brooklyn v. Cuomo, 592 U.S. 14 (2020) (enjoining gathering limits at religious services during COVID pandemic).

The Repeal EO directs agencies to consider repealing regulations without notice and comment under the “good cause” exception in the Administrative Procedure Act, on the grounds that “[r]etaining and enforcing facially unlawful regulations is clearly contrary to the public interest” and “notice-and-comment proceedings are “unnecessary” where repeal is required as a matter of law to ensure consistency with a ruling of the United States Supreme Court.”

On April 11, 2025, the Office of Management and Budget published a notice in the Federal Register seeking comment on “regulations that are unnecessary, unlawful, unduly burdensome, or unsound” for consideration of repeal. The comment period will last for 30 days.

FDA-regulated companies should consider the legal support for burdensome FDA or CMS regulations and the viability of repeal of these regulations from both legal and policy perspectives. Our Food, Drug, and Device and Health Care groups will be monitoring this docket and analyzing regulations that may be appropriate for repeal. We would be glad to discuss with you regulations relevant to your business that might be considered for repeal, as well as advising you on comments that could be submitted to this docket.

If you have any questions concerning the material discussed in this client alert, please contact members of our Food, Drugs, and Devices practice.