Lexology December 11, 2025
In 2025, legal pressures on federal drug pricing policy escalated to a fever pitch. The Trump administration resurrected a version of its most-favored-nation (MFN) drug pricing policy from President Donald Trump’s first term and continued implementation of Maximum Fair Price (MFP) requirements under the Inflation Reduction Act (IRA). At the same time, the Centers for Medicare & Medicaid Services (CMS) surprised the industry by tightening pricing rules on physician-administered medicines, such as essential oncology and immunology therapies. Amidst these changes, Congress weighed in by expanding the orphan drug exclusion to the Medicare Drug Price Negotiation Program, a move lauded as offering targeted and necessary relief to preserve incentives for rare disease innovation.
Together, these developments underscore that no single...
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