- FDA and the Department of Health and Human Services (HHS) have launched a public Request for Information (RFI) to “identify and eliminate outdated or unnecessary regulations” in alignment with President Donald Trump’s Executive Order 14192.
- Under the RFI, HHS Secretary Robert F. Kennedy, Jr. has committed to rescinding at least ten existing regulatory actions for every new regulation proposed. The effort is intended to “lower the cost of living, remove bureaucratic barriers, and allow health care providers to devote more time and resources to patient care.”
- HHS intends to implement the following measures under the Executive Order:
- The 10-to-1 rule: Eliminate at least ten existing regulations for every new regulation introduced.
- 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 to guidance documents, memoranda, policy statements, and similar directives, in addition to formal regulations.
- Radical transparency: HHS will publish annual reports detailing estimated regulatory costs and the specific rules being offset.
- According to FDA Commissioner Marty Makary, “[t]his initiative is about restoring common sense to health care regulation. . . .We welcome public input to help identify reforms that truly make a difference.”
- During an FDA Update session at the Food and Drug Law Institute’s (FDLIs) Annual Meeting in Washington, D.C., FDA officials reiterated the Agency’s commitment to transparency and complying with the Executive Order while also working toward FDA’s priorities. For example, the Agency has moved forward with approving new uses for three non-certified color additives as part of the Agency’s strategy to phase out certified color additives, as we previously blogged.
- The RFI’s 60-day public comment period opened May 13, 2025. Comments may be submitted through regulations.gov under docket AHRQ-2025-0001 or at regulations.gov/deregulation.
- Keller and Heckman is available to assist in submitting public comments and will continue to monitor other FDA developments.
