Mintz IRA Update Q3 2025 Analyzes Inflation Reduction Act Impact on Pharma

The Mintz IRA Update Q3 2025 edition offers a detailed examination of ongoing developments related to the Inflation Reduction Act of 2022 (IRA) and its broad implications for pharmaceutical supply chain stakeholders. This edition highlights key elements such as CMS’s draft guidance for the third cycle of the Medicare Drug Price Negotiation Program, recent court rulings that uphold the government’s stance on the program’s voluntary Medicare participation, and the finalized 2026 Part D Redesign Program instructions aimed at improving drug affordability and coverage clarity.

The publication also reviews the Trump administration’s past executive actions on drug pricing, reflecting their continued influence on current policy and market dynamics. Significant attention is given to PhRMA’s 2025 policy agenda, which underscores industry challenges and strategic positioning in response to evolving US drug pricing reforms, including regulatory oversight, supply chain management, and market access programs. Additionally, the update explores emerging pharmaceutical distribution shifts prompted by drug pricing mandates, such as increased direct-to-consumer delivery and telehealth partnerships with regulatory implications.

Attention to regulatory and policy impacts extends to Medicare Part B Physician Fee Schedule proposed rules affecting Part D and the rising role of GLP-1 drugs in obesity treatment, raising questions about access, affordability, and future public health policies. Overall, this report is a resource for stakeholders seeking to understand the intersection of legislative measures, judicial decisions, and evolving industry responses shaping the US pharmaceutical landscape.