|
Pharmaceutical Industry Antitrust Handbook |
 |
|
|
|
|
|
|
Pharmaceuticals play a major role in the U.S. economy and in the health of Americans. Billions of prescriptions are filled annually, costing well over a hundred billion dollars. With pharmaceuticals representing such an important part of the nation's economy and the health care sector, competition in the pharmaceutical industry is crucial to provide the best quality drugs for the lowest possible price. Antitrust enforcement plays a key role in ensuring competition in this industry.
Written for the antitrust and pharmaceutical communities, the Pharmaceutical Industry Handbook is intended to provide comprehensive guidance about the analysis of the most important antitrust questions faced today by pharmaceutical companies and participants in related health care industries.
This important resource provides an overview of the pharmaceutical industry, including the market participants, FDA regulatory structure, and background on private litigation and government enforcement. It then addresses the substantive antitrust issues presented by mergers and acquisition, joint ventures, various forms of potentially anticompetitive conduct, and distribution. Finally, it provides the kinds of economic data that are integral to antitrust analysis for this industry.
Chapter I - Market Participants and Competition - including an examination of Market Participants, Generic Manufacturers, Drug Wholesalers, PBMs, Group Purchasing Organizations, Purchasers, Third-Party Payors, Pharmaceutical Transactions and Distribution, Pharmaceutical Competition, Prescription Products, Generic Competition, and Over-the-Counter Drugs
Chapter II - Regulatory and Enforcement Framework - including FDA Approval Requirements, The Hatch-Waxman Amendments, The 2003 MMA Amendments, Patent Term Restoration and Other Exclusivities, The Federal Trade Commission's Generic Drug Study, Government Antitrust Enforcement, State Enforcement, Private Suits and Class Actions, and Government Price Regulation
Chapter III - Assessing Market Power in the Prescription Pharmaceutical Industry - including Market Power, Monopoly Power, and Market Definition, Market Power in Conduct Cases, and Market Power in Merger Cases
Chapter IV - Pharmaceutical Firm Mergers - including Merger Review Process, Substantive Merger Analysis, Horizontal Mergers between Direct Competitors, Contractual Relationships Analyzed As Potential Competition, Innovation Competition, and Remedies.
Chapter V - Joint Ventures and Licensing Agreements - including Joint Venture Analysis, Joint Research and Development Agreements, Co-Promotion, Co-Marketing, and Distribution Agreements, Pharmacy Networks, and Authorized Generics.
Chapter VI - Antitrust Issues Raised by Pharmaceutical Manufacturer Conduct - Including Pharmaceutical Patent Settlements, Recent Legislative Action Concerning Pharmaceutical Settlements, Hatch-Waxman Patent Settlement Filing Requirements, Other Horizontal and Vertical Agreements, Litigation Abuse, Abuse of the Pharmaceutical Regulatory Scheme, New Drug Formulations and Product "Switching" Strategies.
Chapter VII - Antitrust Issues in the Distribution of Pharmaceutical Products - Including Mergers and Acquisitions Involving Drug Wholesalers, Pharmacy Retailers, Prescription Benefit Managers, and Group Purchasing Organizations. Also, Exclusive Dealing, Loyalty Discounts, and Bundling and Market Share Discounts
Appendix - Economists' Use of Industry Data In Antitrust Cases, Marketing and Promotion, Product, Physician, Patient, and Payor Characteristics, Examples of Pharmaceutical Data Sources Used in Health Economics Literature, Economic Applications of Pharmaceutical Industry Data Sources for Litigation, Quality-Adjusted Price Analysis to Inform Exercise of Market Power, Switching Analysis to Inform Market Definition Demand Analysis to Inform Impact of Price Collusion, Conclusion
|
|
|
|
|
|
