Health Law Advisor

On October 21, 2025, the acting administrator of the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget issued Memorandum M-25-36, which contains guidance for federal agencies on “how to bolster, streamline, and speed” the deregulatory agenda prioritized by the Trump administration in 2025 (“the Memorandum” or “M-25-36”).

The Memorandum furthers two Executive Orders (EOs) issued earlier in the year. EO 14192, entitled “Unleashing Prosperity Through Deregulation,” requires that for every new regulation issued, ten must be repealed. EO 14219 seeks to ensure “Lawful Governance” to implement the president’s Department of Government Efficiency Deregulatory Initiative. M-25-36 also furthers a Presidential Memorandum of April 9, 2025, entitled “Directing the Repeal of Unlawful Regulations.”

The Memorandum, which establishes timelines and guidelines for OIRA review, focuses on: 1) speeding up the OIRA review process; 2) repealing facially unlawful regulations; and 3) developing better deregulatory records. We discuss each of these sections in turn before providing some thoughts in the health care context.

As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of Information and Regulatory Affairs (“OIRA”) within the Office of Management and Budget (“OMB”). While review by OIRA is capped at 90 days by Executive Order 12866, there is no minimum period required, and therefore action can be taken any time between now and June.

During this election year, FDA’s efforts to push the rule forward fairly quickly is ...