Regulatory Freeze Pending Review: What It Means for Federal Rulemaking

On January 20, 2025, President Trump issued an executive memorandum announcing a “regulatory freeze,” halting federal rulemaking activity across all executive departments and agencies pending review and approval by new administration appointees. Key provisions include:

• No New Rules: No proposed or final rules may be issued until they are reviewed and approved by an appointee designated by the President. Rules addressing emergencies or urgent circumstances, such as those subject to statutory or judicial deadlines requiring prompt action, may be exempted by the Director or Acting Director of the Office of Management and Budget (OMB).
• Immediate Withdrawal: Rules submitted to the Federal Register but not yet published, or “any rules that have been issued in any manner but have not taken effect,” must be immediately withdrawn for review and approval.
• 60-day Delay: Agencies are directed to postpone the effective dates of any rules published in the Federal Register, or any rules issued but not yet effective, by 60 days. They are also encouraged to consider opening a comment period to allow interested parties to provide input on relevant questions of fact, law, and policy that may arise during the review.
• Further Action: Rules that raise no substantial questions of fact, law, or policy may proceed following review, while those raising concerns will require further agency action in consultation with the OMB Director.

This freeze applies broadly—extending not only to rules but also to “any regulatory action,” guidance document, or substantive action by an agency that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking.

The OMB Director has been authorized to establish a review process and oversee the implementation of the President’s orders. While it is customary for incoming administrations to implement regulatory freezes, the specific policy directions the current administration will take affecting health law and the life sciences remain uncertain.