On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a Request for Information (RFI) to identify outdated, duplicative, or unnecessary regulations. This move supports a wider federal effort to reduce regulatory burdens and enhance transparency, in accordance with Executive Order 14192: Unleashing Prosperity Through Deregulation.
A Bold Deregulatory Mandate
As part of this initiative, HHS Secretary Robert F. Kennedy, Jr. has committed to a “10-to-1” deregulatory policy—for every new regulation introduced, at least ten existing regulatory actions must be rescinded. The goal: reduce compliance burdens, simplify healthcare operations, and encourage innovation, while upholding safety and efficacy standards.
Key Components of the Initiative
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10-to-1 Rule: For each new regulation, a minimum of ten existing rules must be eliminated.
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Regulatory Cost Cap: The total net cost of all new regulations in FY2025 must be significantly below zero.
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Expanded Scope: The policy applies not only to formal regulations but also to guidance documents, memoranda, policy statements, and similar directives.
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Annual Transparency Reports: HHS will publish annual updates detailing which regulations were modified or removed, along with estimated cost savings.
Stakeholder Engagement
The RFI invites input from a wide range of stakeholders—businesses, healthcare providers, and the general public—to identify specific regulations that are outdated or unnecessarily burdensome.
📄 Access the official request here:
Request for Information – Federal Register
🗓️ Submission deadline: July 12, 2025
Implications for the Healthcare Industry
This deregulatory push could lead to significant changes in regulatory requirements for various healthcare products—including pharmaceuticals, medical devices, and biologics. The final impact on compliance strategies, operational costs, and product approval timelines will depend on which regulations are ultimately revised or removed.
Next Steps for Industry
Organizations should assess their current regulatory challenges and consider submitting comments during the public consultation period.
👉 Please ask RegASK to monitor HHS updates and participate in relevant consultations to stay aligned with forthcoming regulatory changes.
