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May 13, 2025
by Joanne S. Eglovitch

10-to-1: HHS solicits comments on regulations to eliminate under Trump EO

The US Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) are seeking public input on regulations, rules, or guidelines that should be eliminated under President Donald Trump’s deregulatory agenda.
 
The agencies said the effort is meant to “reduce regulatory burdens and increase transparency,” in alignment with an executive order signed in late January that instructs federal agencies to withdraw 10 existing regulations, rules, or guidelines for every new one that is promulgated. The executive order also specifies that the total cost of all new regulations in fiscal year 2025 must be significantly less than zero. The order applies not only to formal regulations but also to guidance documents, memoranda, policy statements, and similar directives. (RELATED: Trump’s 10-for-1 order puts pressure on FDA to find regulations to nix, Regulatory Focus 7 February 2025)
 
“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 in announcing the call for public feedback. “We cannot allow their time and talent to be wasted on bureaucratic red tape and paperwork.”
 
“This initiative is about restoring common sense to health care regulation,” said FDA Commissioner Marty Makary. “By cutting outdated red tape, we can lower costs, increase access to innovation, and let clinicians spend more time with patients—not paperwork.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.”
 
In the solicitation, HHS asks which regulations or guidances should be eliminated and what the cost savings and impact of doing so would be for policies that meet seven criteria laid out in the notice. The criteria include policies that are unconstitutional, are based on unlawful delegations of legislative power, and that impose significant costs on private parties that are not made up by public benefits they provide. The agency also wants to know what regulations could be eliminated in order to achieve its policy goal of reversing chronic disease and whether there are regulations, guidance, or reporting requirements that rely on outdated technology that could be rescinded or improved.
 
The 60-day public comment period begins today. Stakeholders are invited to share their suggestions for deregulatory actions through the Regulations.gov docket (AHRQ-2025-0001) or a dedicated portal found at Regulations.gov/Deregulation.
 
Alongside the request for comments, HHS issued a separate notice identifying four documents for immediate recission, including a COVID-19 era notice on scarce or threatened materials subject to hoarding prevention measures and practice guidelines for the administration of buprenorphine for treating opioid use disorder.
 
“This is the beginning of a new era for HHS and American health more broadly. In this new era, patient choice and individual freedom will predominate over burdensome federal regulations. In this document, we are taking the first step towards making that a reality,” HHS wrote in the Federal Register announcement rescinding the four documents.
 
Federal Register Notice, FDA
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