FDA launches effort to identify, slash outdated healthcare regulations under 10-to-1 rule

Editor's Note

The US Food and Drug Administration (FDA) and US Department of Health and Human Services (HHS) have launched a public Request for Information (RFI) to identify and eliminate outdated healthcare regulations, according to a May 13 press release from the FDA. The move supports a broader federal deregulatory initiative under Executive Order 14192, titled “Unleashing Prosperity Through Deregulation.”

Under the order, HHS will adopt a “10-to-1” rule, requiring the repeal of at least ten existing regulations for every new one proposed. The agency must also keep the total cost of all new regulations in fiscal year 2025 significantly below zero. The policy applies to a wide range of regulatory instruments, including formal rules, guidance documents, policy statements, and memoranda.

HHS Secretary Robert F. Kennedy, Jr. stated that the goal is to reduce administrative burdens that divert healthcare providers from patient care. FDA Commissioner Marty Makary added that eliminating outdated requirements could reduce costs, improve access to innovation, and allow clinicians to focus more on care delivery.

To increase transparency, HHS will publish annual reports outlining the estimated costs of new rules and identifying which existing regulations are being offset. A 60-day public comment period begins immediately. Stakeholders are invited to submit deregulatory proposals via the Regulations.gov portal (Docket AHRQ-2025-0001), which includes tools to help users shape formal recommendations.

As reported by Modern Healthcare, The American Hospital Association (AHA) has already suggested more than 100 regulations to eliminate, including those related to billing, quality reporting, staffing, and more.