REGULATORY UPDATE: HHS, FDA Seek Input on Deregulatory Plan
May 13, 2025
The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration released a request for information on Tuesday to identify outdated or unnecessary regulations within the U.S. health care system. The
initiative is part of a broader federal effort to reduce regulatory burdens in accordance with Executive Order 14192,
Unleashing Prosperity Through Deregulation.
As part of the effort, HHS Secretary Robert F. Kennedy, Jr.
announced a “10-to-1” deregulatory policy, under which at least ten existing regulations must be rescinded for every new one proposed. The plan also includes a regulatory cost cap, requiring that the total cost of all new regulations in fiscal year 2025 to be “significantly less than zero.” In addition, the scope of the initiative extends beyond formal regulations to include guidance documents, memoranda and policy statements.
HHS will also publish annual reports detailing estimated regulatory costs and the specific rules being offset, which the agency believes will promote greater transparency and accountability.
A 60-day public comment period is now open. HHS invites stakeholders to submit ideas through the docket at Regulations.gov (AHRQ-2025-0001) or
through an online portal.
AABB encourages members of the blood and biotherapies community to share feedback with FDA online or with AABB
via email.
