Breaking: FDA, HHS Seek Public Input on Cutting Rules

On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary regulations.” The 60-day public comment period opened earlier this week and encourages stakeholders to submit their ideas for deregulatory actions.

According to the press release, under President Trump’s Executive Order 14192, HHS will implement the following measures:

• The 10-to-1 rule: For every new regulation introduced, at least ten existing regulations must be eliminated.
• Regulatory cost cap: The total cost of all new regulations in fiscal year 2025 must be significantly less than zero.
• Expanded scope: The order applies not only to formal regulations but also to guidance documents, memoranda, policy statements, and similar directives.
• Radical transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset, promoting greater transparency and accountability.

Before submitting any recommendations (if any), you may wish to consult your trusted health law attorney to learn how the regulations that exist operate in practice, how they (or their absence might) affect your day-to-day practice, how the regulations mirror or depart from legal best practices for your business, how they safeguard or increase your potential liability, how they protect your patients/clients and/or add administrative burdens to your practice, and the public policy implications of deregulation of any particular legal provision.

You can find HHS’ press release here. 

You can find a copy of Executive Order 14192 (dated January 31, 2025) here.

You can watch the video of HHS Secretary Robert F. Kennedy’s announcement of the 10 to 1 Deregulatory Agenda here.

To submit deregulatory recommendations, see here or the newly launched online portal. Per the press release, “[t]he portal also includes tools to assist users in drafting proposals that HHS may formally consider.”