HHS and FDA Launch RFI on Deregulatory Plan — A Key Opportunity to Shape Health and Food Policy

At a Glance

• Stakeholders should be thoughtful about the issues raised through this process and engage in ways that the administration will find credibly helpful to its “Make America Healthy Again” agenda.
• This RFI is a strategic opening to shape policy by submitting thoughtful, actionable proposals for FDA consideration. Stakeholders can help FDA identify and reform outdated or duplicative requirements, potentially reducing compliance costs and accelerating product development timelines.
• The 60-day comment period will end on July 14, 2025, and submissions can be made through Regulations.gov (docket AHRQ-2025-0001) or an online portal (Regulations.gov/deregulation).

The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have issued a request for information (RFI) to identify outdated or burdensome regulations for elimination. This RFI is part of a broader deregulatory initiative under President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation,” announcing the “10-to-1” policy, requiring the rescission of at least 10 existing policies (broadly defined to include regulations, guidances and more) for every new one proposed, alongside a regulatory cost cap ensuring a significant net reduction in costs for fiscal year 2025. This initiative, led by HHS Secretary Robert F. Kennedy, Jr., and FDA Commissioner Dr. Marty Makary, aims to reduce bureaucratic barriers; lower costs; and empower innovators, researchers, and health care providers to prioritize innovation and patient care over paperwork.

The scope of this deregulatory effort is expansive, targeting not only formal regulations but also guidance documents, memoranda, policy statements and other directives. By inviting public input during a 60-day comment period, HHS and FDA are actively seeking new perspectives to identify regulations that unnecessarily hinder innovation, inflate costs or divert resources from patient care.

However, stakeholders should be thoughtful about the issues raised through this process and engage in ways that the administration will find credibly helpful to its “Make America Healthy Again” agenda. In the launch video for this initiative, Secretary Kennedy contrasted this RFI against past deregulatory efforts that “usually meant removing barriers to unfettered corporate profit taking.” Instead, he described this effort as one meant to provide a clearer, more predictable framework and to identify hurdles to providers “treating and preventing chronic disease instead of clearing unnecessary regulatory hurdles.” He also explicitly stated that regulation can often benefit large incumbents with “entire compliance departments and legions of lawyers,” at the expense of smaller companies and competition that drives lower costs.

HHS is likely to be sensitive to attempts to use this deregulatory plan as a Trojan horse for stakeholders to advance priorities either outside of the intended scope or that present genuine public health or competition concerns.

Engaging Through the RFI Process

This RFI is a strategic opening to shape policy by submitting thoughtful, actionable proposals for FDA consideration. Stakeholders can help FDA identify and reform outdated or duplicative requirements, potentially reducing compliance costs and accelerating product development timelines. This opportunity is magnified by recent staffing changes at FDA that have brought new personnel to the agency, giving stakeholders an opportunity to help educate officials on reform opportunities.

Stakeholders should act swiftly to analyze their regulatory challenges, craft targeted recommendations and use this opportunity to engage with FDA on potential reforms. The 60-day comment period will end on July 14, 2025, and submissions can be made through Regulations.gov (docket AHRQ-2025-0001) or an online portal (Regulations.gov/deregulation).

This RFI presents a critical opportunity for stakeholders to engage with FDA to modernize drug, biologic, medical device and food regulation to better serve patients and consumers.

For More Information

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