First 100 Days: Upcoming Regulatory Signals for Healthcare/Life Sciences

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”)

White House

Implementation of the Executive Actions “Regulatory Freeze Pending Review” and “Unleashing Prosperity Through Deregulation”

White House here and here

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:

• Decreasing of regulatory focus on Medicare Advantage plans
• Increased flexibility for healthcare mergers and acquisitions
• A focus on lowering prescription drug costs, with the potential for new policies anticipated for price negotiation
• New regulations in specific agency/Administration priority areas (e.g., bans on food additives, state-directed Medicaid, Medicaid/CHIP Expansion Program)

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

Implementation of DOJ Memo re-prioritizing enforcement focus of FCPA to foreign bribery that facilitates the criminal operations of Cartels and Transnational Criminal Organizations

DOJ Memo

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

White House

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)

White House

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

White House

Reassessment of trade agreements including the:

• United States-Mexico-Canada Agreement (USMCA)
• World Trade Organization Agreement on Government Procurement 
• Execution of tariffs/duties for select countries and/or sectors

White House

White House Actions, here, here, and here

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))

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

White House here and here

HHS secretary statement

Food Additives

• Comprehensive review of health factors including diet, “toxins”, food production techniques, corporate influence, and government policies, with an initial focus on childhood chronic disease
• Commission to deliver a detailed assessment and strategic plan for restructuring federal health responses within specified timeframes, ensuring ethical transparency and expert input

White House

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

White House

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)

White House

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

White House Actions here and here

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

White House