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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.
Key Features¿Understand the Interconnectedness of U.S. Federal Policies.
¿Analyze the Strategic Impacts of Key Legislation and Executive Actions.
¿Evaluate Challenges and Opportunities in a Dynamic Regulatory Environment.
¿Analyze the Interplay of U.S. Federal Actions and Industry Operations.
¿Formulate Adaptive Strategies for Industry Resilience.
List of contents
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.
About the author
Molly Klote, MD, 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 over 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 for 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, served as an Institutional Official, 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.
