Adapting to Change

Federal Policy Dynamics and the Pharmaceutical Industry
1. Auflage 2025
ISBN: 978-1-041-15981-0
Verlag: CRC Press

Buch, Englisch, 120 Seiten, Format (B × H): 138 mm x 216 mm

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.

Zielgruppe

Academic, Postgraduate, Professional Practice & Development, and Professional Reference

Autoren/Hrsg.

Klote, Molly

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Pharmazie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

Chapter 1: Introduction – Adapting to Change. Chapter 2: Key Forces Impacting Pharma. Chapter 3: Additional Emerging Policy Dynamics. Chapter 4: Small Businesses in the New Pharma Paradigm. Chapter 5: Impact of/on Compounding Pharmacies. Chapter 6: The Most Favored Nation (MFN) Drug Pricing Executive Order. Chapter 7: Medicare Part B vs. Part D Drug Coverage. Chapter 8: International Impacts on Pharma. Chapter 9: Strategic Recommendations for the Pharmaceutical Industry. Chapter 10: Conclusion – Forging the Future – Resilience and Value in Pharma's New Era.

Über Autor(innen)

Dr. Molly Klote is the former Director of the US Department of Health and Human Services Office for Human Research Protections (OHRP). OHRP is the policy, education and compliance office that oversees federally funded medical research for 21 federal agencies, 13,000 institutions and >6000 institutional review boards in the US and internationally. It is the proponent office for the policy that is called “The Common Rule” (45 CFR 46). Before joining OHRP, Dr. Klote spent six years as the research policy, regulatory, and education lead for the Veterans Health Administration, the largest integrated healthcare system in the United States. Prior to the Veterans Health Administration, she served 30 years in the Army with her final assignment at the rank of Colonel working for the Army Surgeon General overseeing all US Army Human Research policy and compliance. Additionally, Dr. Klote has directed two major research program offices, chaired three Institutional Review Boards, and led a Research Scientific Review Board. She recently launched her own consulting company, Klote Medical Research Advisors, LLC to bring her over 36 years of distinguished military and civilian federal experience to those who need to better understand federal research policy.