The 111th U.S. Congress Tackles Healthcare Reform and the Pharmaceutical Industry : Market Research Report

The 111th U.S. Congress Tackles Healthcare Reform and the Pharmaceutical Industry

Published: Sep. 10, 2009 - 35 Pages

Executive Summary: Strategic Considerations; Stakeholder Implications
Aggressive First Steps by the 111th Congress
American Recovery and Reinvestment Act of 2009: Comparative Effectiveness Research; The Comparative Effectiveness Research Act of 2009 (H.R. 2502); The Patient-Centered Outcomes Research Act of 2009 (S. 1213); Privacy of Personal Health Information; Health Information Technology for Economic and Clinical Health Act (HITECH Act); New Hampshire’s Prescription Information Law
Importation of Drugs
Authorized Generics and Pay-for-Delay Deals: Reverse Payment Patent Settlements—Pay-for-Delay Deals; Authorized Generics
Biosimilars: Follow-On Biologics: Biosimilar Markets; Data Exclusivity Arguments; Fuqua School of Business at Duke University: Henry G. Grabowski Analysis; Matrix Global Advisors: Alex M. Brill Critique; Federal Trade Commission Gives Input; The Obama Administration Weighs In; Pending Biosimilars Legislation, 2009; Promoting Innovation and Access to Life-Saving Medicine Act, H.R. 1427; Promoting Innovation and Access to Life-Saving Medicine Act, S. 726; Pathway for Biosimilar Act, H.R. 1548
Patent Reform Act of 2009: National Academy of Sciences View; Coalition for 21st Century Patent Reform; Coalition for Patent Fairness View; Breakthrough Compromise in the Senate’s Committee on the Judiciary
All Eyes Turn to Healthcare Reform: Need for Healthcare Reform in the United States; Components of Healthcare Reform
Outlook: SPECTRUM Pharmaceutical Industry Dynamics 11-3; Legislation That Will Impact the Pharmaceutical Industry; Press Date: September 10, 2009 Decision Resources
Expert Commentaries: “Nothing Is Agreed to Until Everything Is Agreed To” by Alex M. Brill, CEO of Matrix Global Advisors and a research fellow at the American Enterprise Institute
Tables: 1. American Recovery and Reinvestment Act of 2009—A $787 Billion Economic Stimulus Bill; 2. New Hampshire’s Prescription Information Law; 3. Legislation to Provide for Drug Importation; 4. Legislation to Prohibit Authorized Generics and Reverse Payments (Pay-for-Delay Deals); 5. Patent Expiries and Anticipated Biosimilar Entry Dates of Key Biologic Brands; 6. Henry G. Grabowski, Duke University Fuqua School of Business: Data Exclusivity Assumptions; 7. Alex M. Brill: Data Exclusivity Analysis Favored by the Generic Pharmaceutical Association; 8. Provisions of the Hatch-Waxman Act of 1984 for Small-Molecule Generics; 9. Biosimilars Legislation as Introduced: H.R. 1427 Promoting Innovation and Access to Life-Saving Medicine Act; 10. Biosimilars Legislation as Introduced: H.R. 1548 Pathway for Biosimilars Act; 11. Legislation to Amend Title 35 of the United States Code to Provide Patent Reform; 12. President Barack Obama’s Eight Key Principles for Guiding Healthcare Reform Efforts in the United States; 13. Legislation to Provide Healthcare Reform
Figures: 1. Handling Personal Information: A Survey by BBC World News America/The Harris Poll,; March 2009; 2. Factors Explaining Future Federal Spending on Medicare, Medicaid, and Social Security

Abstract

In this report
we feature a commentary by Alex M. Brill, CEO of Matrix Global Advisors and a research fellow at the American Enterprise Institute, who testifi ed before the U.S. House Judiciary Committee’s Subcommittee on Courts and Competition on July 14, 2009, regarding data exclusivity for biosimilars. We also provide insights from an interviewed health policy lobbyist who is active in government affairs in Washington, D.C. He spoke on background concerning recent negotiations on healthcare reform, authorized generics, and reverse payment deals. Kevin E. Noonan, J.D., Ph.D., a partner at McDonnell Boehnen Hulbert & Berghoff, gives his insights on patent reform and healthcare reform.

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The 111th U.S. Congress Tackles Healthcare Reform and the Pharmaceutical Industry

Table of Contents

Abstract