HHS, FDA Issue RFI on Deregulatory Plan to Lower Costs and Empower Providers

Background

Consistent with his first term, President Trump has prioritized deregulatory action and has taken significant steps towards that end during his first 100 days in office. The EO “Unleashing Prosperity Through Deregulation” (“10-for-1”) directs that for each new rule proposed or finalized, agencies must identify at least ten existing regulations to be repealed.[1] Another EO, “Implementing the President’s ‘Department of Government Efficiency’ Workforce Optimization Initiative,” directs that each agency may hire no more than one government employee for every four government employees who depart the agency.² Hogan Lovells previously wrote about these executive orders in depth in February.³

Additionally, Executive Order 14219 “Ensuring Lawful Governance and Implementing the President’s ‘Department of Government Efficiency’ Deregulatory Initiative” directs agency heads, in coordination with DOGE and the Office of Management and Budget (OMB), to initiate a process to identify and classify all agency regulations that are “unlawful” or “undermine the national interest,” including regulations that impose “undue burdens” on technological innovation and economic development.⁴

The president then released a memorandum “Directing the Repeal of Unlawful Regulations,”⁵ which instructs agency heads on how to implement Executive Order 14219. Among other things, the memorandum instructs agencies to invoke the “good cause” exception to notice and comment rulemaking under the Administrative Procedure Act when possible, which would let agencies issue interim final rules to repeal regulations. Additionally, OMB issued an RFI (“OMB RFI”) that solicits ideas for deregulation.⁶ Finally, the EO “Reducing Anti-Competitive Regulatory Barriers” directs agency heads to review all regulations that might pose a barrier to competition.⁷ We previously wrote in depth about these deregulatory actions in April.⁸

The HHS RFI follows in the wake of these actions and provides an opportunity specifically for the food industry to identify deregulatory priorities for the administration.  

Overview of the Request for Information

The RFI builds on several deregulatory actions taken by the second Trump administration and poses broad questions to commenters consistent with the 10-for-1 EO, EO 14219, and requests made in the OMB RFI. Those questions center around identifying deregulatory actions to improve efficiency, removing unnecessary regulatory obstacles, and reducing costs. Of particular note, the RFI asks commentors what regulations HHS should consider as it looks at enacting policy objectives outlined in EO 14212, “Establishing the President's Make America Healthy Again Commission”⁹ to focus on reversing chronic disease. Additionally, HHS notes that the most helpful submissions are those that it can publish in the Federal Register with “minimal revision.”  The complete list of questions for commenters is available in the appendix below.

Agency actions eligible for comment include formal regulations, guidance documents, memoranda, policy statements, and similar directives. The RFI states that HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset to promote HHS Secretary Kennedy’s stated goal of greater transparency and accountability.

The RFI also promotes a new way to submit comments. In addition to the traditional comment process through the RFI’s docket, responses may be submitted through a newly launched “Deregulation suggestions” form. The form appears to have been launched in April in connection with the OMB RFI, although it does not appear tied to a specific docket or deadline. The suggestion form asks several questions about what specific rule should be targeted and lists potential reasons for recission including “the regulation is inconsistent with a statute” and “the regulation is bad policy, unreasoned or unsound.” The Department indicates it will accept anonymous submissions.

Next Steps

We will continue to monitor the Trump Administration’s actions and developing policy agenda. Please contact us if you have any questions or want assistance drafting comments.

Appendix

Questions

1. What HHS regulations and/or guidance meet one or more of the following seven criteria identified in E.O. 14219? Should they be modified or repealed? What would be the impact of this change, especially the costs and savings?

• Unconstitutional regulations and regulations that raise serious constitutional difficulties, such as exceeding the scope of the power vested in the Federal Government by the 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; or
• Regulations that impose undue burdens on small business and impede private enterprise and entrepreneurship.

2. What regulations should we reconsider as we look to achieve some of the policy objectives outlined in Executive Order 14212, “Establishing the President's Make America Healthy Again Commission,” to focus on reversing chronic disease?
3. For more general deregulatory consideration under E.O. 14192, are there additional HHS regulations and/or guidance that: 

• Are confusing or unnecessarily complicated;
• Require an excessive number of reports or unreasonable record keeping, or information that is not needed or used effectively;
• Impose requirements on the wrong individual or group;
• Carry excessive penalties;
• Are conflicting (examples include but are not limited to conflicts between HHS and State regulations, public and private sectors); * Impede access to or delivery of care or services;
• Impede efforts to innovate
• Are obsolete; and/or 
• Otherwise interfere with the public or private sector's ability to address chronic health conditions or otherwise promote the health and wellbeing of Americans? Should they be modified or repealed? What would be the impact of this change, especially the costs and savings?

4. What alternative approaches could be taken to achieve or accomplish the same goal with a lesser burden? For example, are there less burdensome approaches that are used by other entities such as State governments or private companies that could be adopted by HHS to achieve its goal with less burdensome requirements? What would be the impact on costs and savings?
5. Are there HHS regulations, guidance, or reporting requirements that are rooted in outdated technology? Can new technologies be leveraged to allow for rescinding or updating these policies? What are the cost implications?
6. Are there HHS regulations, guidance, or reporting requirements that are inconsistent with Executive Orders 14151, 14154, 14168, and 14213 or others issued by the President? Should they be modified or rescinded to make them consistent?