Overdose

How Excessive Government Regulation Stifles Pharmaceutical Innovation

By: Richard A. Epstein

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Paperback | 2 December 2008 | Edition Number 1

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296 Pages

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23.85 x 16.1 x 1.74

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This book is the first to offer a comprehensive examination of the pharmaceutical industry by following the tortuous course of a new drug as it progresses from early development to final delivery. Richard A. Epstein looks closely at the regulatory framework that surrounds all aspects of making pharmaceutical products today, and he assesses which current legal and regulatory practices make sense and which have gone awry.
While critics of pharmaceutical companies call for ever more stringent controls on virtually every aspect of drug development and approval, Epstein cautions that the effect of such an approach will be to stifle pharmaceutical innovation and slow the delivery of beneficial treatments to the patients who need them. The author considers an array of challenges that confront the industry--conflicts of interest among government, academe, and the drug companies; intellectual property rights that govern patents; FDA regulation; pricing disputes; marketing practices; and liability issues, including those brought to light in the recent VIOXX case. Epstein argues that to ensure the continuing creativity, efficiency, and success of the pharmaceutical industry, the best system will feature strong property rights and clearly enforceable contracts, with minimal regulatory and judicial interference.

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Preface	p. ix
Property and Progress
Rising Expectations-and Diminishing Returns	p. 3
Property Generally: Externalities, Coordination, and the Public Domain	p. 13
Intellectual Property: The Public Domain and Private Rights	p. 18
Maintaining the Public/Private Interface
Taming Conflict of Interests	p. 29
Federally Sponsored Research Under Bayh-Dole	p. 35
Intellectual Property and Its Regulation
The Anticommons	p. 47
The Single Monopoly: Current Patent Limitations	p. 54
Rate Regulation: An Unneeded Swamp	p. 66
Patent Purchases: A Second Swamp	p. 82
Socialization of R&D: The Final Swamp	p. 97
The FDA: Purity, Safety, Effectiveness
The Steady Expansion of FDA Power	p. 109
FDA Versus the Individual: Upstream or Downstream Decision Making	p. 113
Drug Withdrawal: Too Much, Too Soon	p. 132
Pharmaceutical Marketing
Getting the Drugs to Market	p. 143
Deceptive Marketing	p. 165
Liability for Pharmaceuticals
Tort Preliminaries	p. 185
Product Liability for Prescription Drugs: Manufacturing and Design Cases	p. 194
The Main Event: Misrepresentation, Overpromotion, and Duty to Warn	p. 202
Conclusion: Socialized Medicines	p. 237
Notes	p. 241
Index	p. 273
Table of Contents provided by Ingram. All Rights Reserved.

Overdose

How Excessive Government Regulation Stifles Pharmaceutical Innovation

At a Glance

Paperback

Shipping

How to return your order

Defective items

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