Indicators of potential regulatory shifts to agency objectives and regulatory focus
KPMG Regulatory Insights
__________________________________________________________________________________________________________________________________________________
February 2025
Under a mantra of “Make American Healthy Again”, the healthcare and life sciences sectors anticipate a flurry of regulatory changes to come. Incoming and acting agency leadership under initial Executive Orders (including de-regulatory and the Make America Healthy Again Commission) provide preliminary signals for potential regulatory shifts, including:
Across agencies, current, incoming and acting agency leadership is setting parameters for regulatory activity going forward, including initial support for:
Signals | Description/Examples | Source |
---|---|---|
Regulatory Shifts | Recission of previous Executive Orders (e.g., EO 14009, “Strengthening Medicaid and the Affordable Care Act”, EO 14070, “Continuing To Strengthen Americans’ Access to Affordable, Quality Health Coverage”) | |
Implementation of the Executive Actions “Regulatory Freeze Pending Review” and “Unleashing Prosperity Through Deregulation” | ||
Potential changes to guidance, procedures (e.g., Section 1557 of the Affordable Care Act regarding nondiscrimination in health programs that receive federal funding, Section 504 of the Rehabilitation Act of 1973 regarding nondiscrimination on the basis of disability in federally-assisted programs |
| |
Shifts in policy/regulation may include the potential:
|
| |
Funding Pullback | Modification of grant policies (e.g., NIH capping indirect cost reimbursements, spillover cuts to research grants based on changes in Medicare drug price policies) | NIH guidance |
Potential reassessment of user fee programs Uncertainty around extensions of ACA subsidies |
| |
Investigation & Enforcement Shift | Implementation of Executive Order pausing investigations and enforcement of the FCPA and directing review/revision of the related guidelines and policies | White House |
Implementation of DOJ Memo re-prioritizing enforcement focus of FCPA to foreign bribery that facilitates the criminal operations of Cartels and Transnational Criminal Organizations | ||
Potential shift in False Claims Act enforcement |
| |
Interagency coordination
| Implementation of the Executive Order establishing the “Make America Healthy Again Committee”, to be chaired by HHS and comprised of leadership from various departments and agencies (including USDA, VA, EPA, OMB, CDC, NIH), and its initial mission to advise the President on how to address childhood chronic disease through an assessment and related strategy | |
Coordination and assessment of potential consolidation/standards with respect to food safety (including FDA and USDA (e.g., WIC and SNAP coverage)) Coordination between HHS, CMS, and other regulatory bodies regarding healthcare policy implementation. |
| |
Global Divergence | Implementation of Executive Order on “Withdrawing the United States from the World Health Organization (WHO) | |
Implementation of Executive Order on “Revaluating and Realigning United States Foreign Aid”, including pullback on foreign health aid (e.g., USAID) and reevaluation of all foreign aid programs by OMB within first 90 days | ||
Reassessment of trade agreements including the:
| ||
State Activity | Potential for increasing divergence between federal government and patchwork of state laws (e.g., food date labeling - potential for federal standard via USDA/FDA and state laws (e.g., California, Massachusetts)) |
|
In addition to statements regarding agency objectives, current, incoming and acting agency leadership is also noting potential changes in key regulatory areas, including:
Signals | Description/Examples | Source |
---|---|---|
Research “Transparency” | Greater scrutiny of federally funded health research for perceived conflicts of interest, including “ethics review”; increased focus on “transparency” of current data and open-source data Potential for higher barriers to vaccine use, including study design, approval, manufacturing and controls, as well as public meetings / dockets, transparency of data regarding related risks and mitigation measures, and consumer choice |
|
Potential for policy changes, including possible regulation and/or legislative actions related to “psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine… [and] nutraceuticals” | HHS secretary statement | |
Food Additives | Establishment of the Make America Healthy Again Commission to address chronic diseases, emphasizing “transparency” with increased skepticism toward medications
| |
Potential changes to standards for the Generally Recognized as Safe process |
| |
In-vitro fertilization | Implementation of the Executive Order to seek policy recommendation for reducing statutory or regulatory burdens in effort to make IVF treatment more affordable and accessible |
|
Labeling | Potential shift in focus on specific set of products within incoming leadership including HHS, FDA, USDA (e.g., dietary supplements, ultra-processed foods, front-of-package (FOP) nutrition labeling, date labeling) | |
Technology & AI | Implementation of Executive Order on Removing Barriers to American Leadership in AI Naming of Special Advisor for AI and Crypto with responsibilities for overseeing regulatory frameworks, collaboration with officials and stakeholders, including PCAST, and alignment of AI priorities with administration policies | |
Rescission of select previous Administration Executive Orders, including EO 14110, “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence”, regulating AI synthesis of nucleic acids and requiring guidance for AI deployment and risk monitoring in healthcare |
First 100 Days: Upcoming Regulatory Signals for Healthcare/Life Sciences
Indicators of potential regulatory shifts to agency objectives and regulatory focus
Download PDFPoints of View
Insights and analyses of emerging regulatory issues and their impact.
Regulatory Insights View
Series covering regulatory trends and emerging topics
Regulatory Alerts
Quick hitting summaries of specific regulatory developments and their impact.
KPMG Regulatory Insights is the thought leader hub for timely insight on risk and regulatory developments.