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

WASHINGTON, DC—MAY 13, 2025— The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) today announced the launch of a public Request for Information (RFI) to identify and eliminate outdated or unnecessary regulations. The initiative is part of a broader federal effort to reduce regulatory burdens and increase transparency, in alignment with President Trump’s Executive Order 14192, “Unleashing Prosperity Through Deregulation.”

Under the directive, HHS Secretary Robert F. Kennedy, Jr. has committed the Department to a "10-to-1" deregulatory policy: for every new regulation proposed, at least ten existing regulatory actions will be rescinded. The effort is designed to lower the cost of living, remove bureaucratic barriers, and allow health care providers to devote more time and resources to patient care.

“To Make America Healthy Again, we must free our doctors and caregivers to do what they do best—prevent and treat chronic disease,” said Secretary Kennedy.  “We cannot allow their time and talent to be wasted on bureaucratic red tape and paperwork.”

Under the Executive Order, 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.

“This initiative is about restoring common sense to health care regulation,” said FDA Commissioner Marty Makary, M.D., M.P.H. “By cutting outdated red tape, we can lower costs, increase access to innovation, and let clinicians spend more time with patients—not paperwork. We welcome public input to help identify reforms that truly make a difference.”

The 60-day public comment period opens today. Stakeholders are encouraged to submit their ideas for deregulatory actions through the Regulations.gov docket (AHRQ-2025-0001) or the newly launched online portal at Regulations.gov/Deregulation. The portal includes tools to assist users in drafting proposals that HHS may formally consider.