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

Table of Contents

• 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

• “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