By Jordan K. Brossi, Michael J. Werner and Beth Neal Pitman
The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) recently issued a Request for Information (RFI) titled “Ensuring Lawful Regulation and Unleashing Innovation to Make American Healthy Again.” The RFI requests public comments and recommendations on HHS and FDA regulations that should be eliminated “to lower healthcare costs, reduce burdens on physicians, and address the prevalence of chronic disease.” Public comments are due by July 14, 2025.
The RFI is a component of the Trump Administration’s deregulatory approach. The announcement details changes to HHS rulemaking efforts that are consistent with President Donald Trump’s Executive Order (EO) 14192 titled “Unleashing Prosperity Through Deregulation.” EO 14192 seeks to limit the number of regulations issued by federal agencies and reduce regulatory burdens. As part of that aim, HHS will implement the following measures:
- at least 10 existing regulations, guidance documents, memos, policy statements and similar directives will be eliminated for every new regulation proposed
- all new regulations in fiscal year 2025 will be required to cost “significantly less than zero,” indicating new regulations will be expected to generate savings
- HHS will publish annual reports detailing costs associated with new regulations and explanations for how rules being eliminated will offset the cost of implementing new regulations
To inform the HHS decisions on specific regulations to eliminate, the RFI requests information from the public on regulations to be eliminated within the following categories:
- unconstitutional regulations and regulations that raise serious constitutional difficulties, such as exceeding the scope of the power vested in the federal government by the U.S. Constitution
- regulations that are based on unlawful delegations of legislative power
- regulations that are 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
- regulations that impose undue burdens on small businesses and impede private enterprise and entrepreneurship
What’s Next
Public responses to the RFI are voluntary. Stakeholders are asked to identify “the specific regulation, guidance, or requirement at issue along with its administering HHS division” as part of their comments. It is expected that the Trump Administration will take some of the comments it receives into account as it seeks to issue future regulations, including those that are key priorities for the administration, including but not limited to, potential rulemaking in response to EOs on prescription drug pricing.
Interested stakeholders are requested to submit comments by July 14, 2025. Interested stakeholders may submit responses through a newly established portal on Regulations.gov.
Jordan Brossi is a senior public affairs advisor and Michael Werner is a partner in Holland & Knight’s Washington, D.C., office. Beth Pitman is a partner in Holland & Knight’s Birmingham, Alabama, office.