HHS: All Branded Drugs Without Generic or Biosimilar Competition Must Abide by MFN Order Across All Markets

On May 12, 2025, the Trump Administration issued Executive Order 14297, requiring that all branded drugs in the U.S. lacking generic or biosimilar competition must align their prices with the lowest price available in a set of economic peer countries (OECD nations with at least 60% of U.S. GDP per capita)235.

The Department of Health and Human Services (HHS) clarified on May 20, 2025, that this Most-Favored-Nation (MFN) pricing order applies to all such brand products across all markets, and drug manufacturers are expected to commit to this price alignment3.

The order aims to eliminate the disparity where Americans pay much higher prices than consumers in other developed nations, and HHS warned drugmakers to lower prices or face further government action23.

Peer countries for reference pricing are OECD members meeting the specified GDP threshold, ensuring price comparisons are made with similarly developed economies3.

Implementation details include communicating MFN price targets to pharmaceutical manufacturers by June 11, 2025, giving companies a short timeline to comply25.

The biopharma industry is expected to resist the change, citing concerns over its expansive impact and the historical precedent that similar attempts stalled without Congressional legislation3.

Sources:

2. https://www.healthindustrywashingtonwatch.com/2025/05/articles/regulatory-developments/mfn-drug-pricing-executive-order-new-hhs-release-adds-details-on-prices-manufacturers-expected-to-offer/

3. https://www.fiercepharma.com/pharma/all-branded-drugs-not-facing-generic-biosimilar-competition-must-abide-mfn-order-all-markets

5. https://healthcarelifesciences.bakermckenzie.com/2025/05/14/new-white-house-executive-order-to-establish-most-favored-nation-drug-pricing/