E-raamat: Adapting to Change: Federal Policy Dynamics and the Pharmaceutical Industry [Taylor & Francis e-raamat]

The US pharmaceutical landscape is in the midst of impactful shifts. A series of ambitious, aggressive, and often interconnected federal policy changes—from direct drug price controls and sweeping Pharmacy Benefit Manager reforms to strategic initiatives to reshore manufacturing and rapidly evolving FDA approaches—is creating a new reality for industry leaders, innovators, and strategists. In this analysis, a federal policy expert unpacks the complex forces reshaping how life-saving therapies are researched, developed, manufactured, and delivered.

•Understand the Interconnectedness of U.S. Federal Policies: identify and explain how various disparate federal policies—including drug price controls, PBM reforms, manufacturing reshoring initiatives, and FDA regulatory changes—are interconnected and create compounding effects on the pharmaceutical industry.

•Analyze the Strategic Impacts of Key Legislation and Executive Actions: gain a comprehensive understanding of the direct and indirect impacts of major legislative actions like the Inflation Reduction Act and the proposed BIOSECURE Act, as well as recent executive orders, on pharmaceutical R&D, market access, operational costs, and global supply chains.

•Evaluate Challenges and Opportunities in a Dynamic Regulatory Environment: assess the specific challenges (e.g., increased compliance burden, workforce shortages, and supply chain disruptions) and strategic opportunities (e.g., leveraging new FDA programs, domestic partnerships, and market intelligence) presented by the rapidly evolving U.S. regulatory landscape.

•Analyze the Interplay of U.S. Federal Actions and Industry Operations: analyze how the confluence of U.S. federal laws, executive orders, regulations, and proposed legislation regarding drug pricing, manufacturing, and regulatory science collectively influence pharmaceutical industry decision-making, operational models, and investment priorities.

•Formulate Adaptive Strategies for Industry Resilience: develop a proactive and agile business models, including scenario planning, strategic investments, and enhanced stakeholder engagement, to navigate regulatory uncertainty and ensure the continued delivery of innovative therapies.

The US pharmaceutical landscape is in the midst of impactful shifts. In this analysis, a federal policy expert unpacks the complex forces reshaping how life-saving therapies are researched, developed, manufactured, and delivered.