While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Author(s): Robin Feldman, Evan Frondorf
Publisher: Cambridge University Press
Year: 2017
Language: English
Pages: 166
Tags: Drug Costs, Drugs, Generic: Supply & Distribution, Patents As Topic, Drug Industry: Economics, Drug Industry: Legislation & Jurisprudence, Economic Competition: Legislation & Jurisprudence, United States
Cover......Page 1
Half-title......Page 3
Title page......Page 5
Copyright information......Page 6
Dedication......Page 7
Table of contents......Page 9
List of table and figures......Page 11
Acknowledgments......Page 13
A Pharma under Fire......Page 15
B A Note before We Begin......Page 26
C The Strange Economics of Pharmaceuticals......Page 27
D Generics – a Brief Primer......Page 33
Introduction......Page 40
A The Basic Contours of Pay-for-Delay......Page 48
B Pay-for-Delay as a Bottleneck to Entry......Page 52
C Is Pay-for-Delay Actually Wrong? Pharma Heads to the Supreme Court......Page 55
A Already Steps Ahead of Actavis......Page 63
B In re Lipitor: Everything but the Kitchen Sink......Page 67
C The Post-Actavis Landscape, Contract Clauses, and King Drug......Page 70
A A New Generation of Pharmaceutical Delay......Page 80
B Product Hopping and the Purple Pill......Page 83
C New Examples of Product Hopping......Page 88
D Scout’s Honor in Product Hopping......Page 92
A REMS-Based Delay......Page 94
B Delay via Citizen Petition......Page 105
C Preventing the “Skinny Label”: Blocking Carve-Outs......Page 116
5 Empirical Evidence of a Citizen’s Pathway Gone Astray......Page 127
1 Overview......Page 129
2 Compiling All Citizen Petitions from 2000 to 2012......Page 130
3 Identifying Citizen Petitions That Could Delay Generic Competition......Page 131
i Filing Dates for Generic Applications......Page 133
ii Matching Citizen Petitions to Relevant Applications......Page 134
iii Establishing Key Metrics......Page 135
1 Rise in Citizen Petitions with the Potential to Delay......Page 136
2 When Are Citizen Petitions Filed in Relation to Final Approval?......Page 137
3 How Did the 2007 Amendments Affect Citizen Petition Timing?......Page 139
4 Did the 2007 Amendments Do the Job?......Page 142
1 A Simple Prohibition......Page 145
2 Procedural Blocks......Page 146
3 Punitive Deterrents......Page 147
4 Transparency......Page 149
Conclusion......Page 151
A Societal Harms......Page 152
B Systems, Simplification, Sunshine, and Standards-Based Doctrines......Page 153
Index......Page 159
