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Acknowledgments

• Acknowledgments

CHAPTER 1 The Food and Drug Administration

• CHAPTER § 1.01 FDA Regulation of Investigational New Drugs
• CHAPTER § 1.02 Clinical Trials Registration and Results Disclosure Requirements
• CHAPTER § 1.03 FDA Approval of New Drug Applications and Supplemental New Drug Applications
• CHAPTER § 1.04 Postmarketing Adverse Events
• CHAPTER § 1.05 Product Recalls
• CHAPTER § 1.06 Violations of FDA's Good Manufacturing Practice Requirements
• CHAPTER § 1.07 FDA's Requirements for Prescription Drug Advertising and Promotion
• CHAPTER § 1.08 Obtaining Admissible Evidence and Testimony from FDA

CHAPTER 10 Third-Party Payors as Plaintiffs: Causes of Action and Defense Strategies

• CHAPTER § 10.01 Introduction
• CHAPTER § 10.02 Third-Party Payors: Who They Are and What They Do
• CHAPTER § 10.03 Standing and Remoteness
• CHAPTER § 10.04 State and Federal Causes of Action and Defenses
• CHAPTER § 10.05 Defenses to Class Certification in TPP Cases

CHAPTER 11 Securities Litigation

• CHAPTER § 11.01 Introduction
• CHAPTER § 11.02 Private Liability Under Federal Securities Laws
• CHAPTER § 11.03 A Review of Securities Fraud Complaints Against Pharmaceutical Companies
• CHAPTER § 11.04 Conclusion and Recommendations

CHAPTER 12 Privilege Issues for Pharmaceutical Manufacturers

• CHAPTER §12.01 Introduction
• CHAPTER §12.02 The Attorney-Client Privilege
• CHAPTER §12.03 The Work-Product Doctrine
• CHAPTER § 12.04 Choice of Law in Federal Cases
• CHAPTER § 12.05 Self-Critical-Analysis Privilege
• CHAPTER § 12.06 New Technology and Privilege

CHAPTER 2 Controlled Substances or Listed Chemicals

• CHAPTER § 2.01 Introduction
• CHAPTER § 2.02 Regulation of Controlled Substances
• CHAPTER § 2.03 Controlled Substance Regulatory Requirements
• CHAPTER § 2.04 Listed Chemicals
• CHAPTER § 2.05 Listed-Chemical Regulatory Requirements
• CHAPTER § 2.06 State-Law Issues
• CHAPTER § 2.07 Practical Considerations

CHAPTER 3 Intellectual Property Issues for Pharmaceutical Manufacturers

• CHAPTER § 3.01 Using Patents to Protect Pharmaceutical Research
• CHAPTER § 3.02 An Overview of Patent Enforcement Actions Under the Hatch-Waxman Act and Biologics Price Competition and Innovation Act
• CHAPTER § 3.03 Litigation Practices and Liability
• CHAPTER § 3.04 Protecting Other Intellectual Property
• CHAPTER § 3.05 Patent Office Alternatives to Patent Litigation
• CHAPTER § 3.06 Licensing Intellectual Property

CHAPTER 4 Antitrust Issues

• CHAPTER § 4.01 Framework of Antitrust Law
• CHAPTER § 4.02 Brand/Generic Antitrust Issues
• CHAPTER § 4.03 Pharmaceutical and Device Company Mergers
• CHAPTER § 4.04 Joint Research, Marketing, and Selling Arrangements
• CHAPTER § 4.05 Antitrust Issues in Sales, Marketing, and Pricing

CHAPTER 5 Insurance Coverage

• CHAPTER § 5.01 Introduction to Insurance Coverage Issues
• CHAPTER § 5.02 Basic Insurance Concepts
• CHAPTER § 5.03 Insurance Coverages for First-Party Losses
• CHAPTER § 5.04 Insurance Coverage for Third-Party Losses
• CHAPTER § 5.05 Excess and Umbrella Coverage
• CHAPTER § 5.06 Exclusions
• CHAPTER § 5.07 Applying for Insurance
• CHAPTER § 5.08 Importance of Notice Provisions
• CHAPTER § 5.09 When a Claim Arises: Handling of Claims Negotiations
• CHAPTER § 5.10 When a Claim Arises: Role of Brokers in Claim Management
• CHAPTER § 5.11 Specific Issues in the Pharmaceutical Industry: Claims Involving Multiple Policy Periods
• CHAPTER § 5.12 Specific Issues in the Pharmaceutical Industry: Emerging Issues
• CHAPTER § 5.13 Insurance in Corporate Transactions
• CHAPTER § 5.14 Alternative Risk Transfers or Sources of Indemnification
• CHAPTER § 5.15 Conclusion

CHAPTER 6 Veil Piercing, Direct Parent Liability, and Successor Liability

• CHAPTER § 6.01 Introduction
• CHAPTER § 6.02 Piercing the Corporate Veil
• CHAPTER § 6.03 Direct Parent Liability
• CHAPTER § 6.04 Successor Liability for Pre-Acquisition Conduct of a Subsidiary
• CHAPTER § 6.05 Practical Advice

CHAPTER 7 Government Enforcement Activity

• CHAPTER §7.01 Increased Government-Enforcement Activity
• CHAPTER §7.02 Area of Government Interest: Off-Label Promotion
• CHAPTER §7.03 Area of Government Interest: The Anti-Kickback Statute
• CHAPTER §7.04 Area of Government Interest: The Controlled Substances Act

CHAPTER 8 Retaliation Claims Asserted by Whistleblowers

• CHAPTER § 8.01 General
• CHAPTER § 8.02 Whistleblower Protection Under the Sarbanes-Oxley Act of 2002
• CHAPTER § 8.03 Whistleblower Protection Under the Dodd-Frank Act
• CHAPTER § 8.04 Whistleblower Protection Under the False Claims Act
• CHAPTER § 8.05 Preventing and Defending Retaliation Claims

CHAPTER 9 Product Liability

• CHAPTER § 9.01 Introduction
• CHAPTER § 9.02 Common Defenses
• CHAPTER § 9.03 The Learned-Intermediary Doctrine
• CHAPTER § 9.04 The Admissibility of Medical Causation Evidence
• CHAPTER § 9.05 Preemption
• CHAPTER § 9.06 State Product Liability Acts' Exemption of FDA-Approved Products
• CHAPTER § 9.07 Medicare Secondary Payer Act

Introduction

• Introduction

Regulation of Pharmaceutical Manufacturers

• REGULATION OF PHARMACEUTICAL MANUFACTURERS