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How Excessive Government Regulation Stifles Pharmaceutical Innovation
Richard A. Epstein
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Format: PaperPrice: $37.00
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An analysis of how we regulate the pharmaceutical industry: are we protecting patients or blocking the development of useful new drugs?
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.
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.
Richard A. Epstein is James Parker Hall Distinguished Service Professor of Law, University of Chicago, and Peter and Kirstin Bedford Senior Fellow at the Hoover Institution.
“In recent years, the pharmaceutical industry has come under often one-sided criticism from observers such as Marcia Angell. This book, while sure to be controversial, is in large part a healthy corrective to these works.”—Josh Lerner, author of Innovation and Its Discontents
"Epstein hits just about every issue in today’s intense debate over the pharmaceutical industry."—John Calfee, New York Post
“[An illuminating new book.”—Diana Furchtgott-Roth, New York Sun
"Provides a very timely examination of the pharmaceutical industry."—Robert M. Howard, The Law and Politics Book Review
ISBN: 9780300143263
Publication Date: December 2, 2008
Publication Date: December 2, 2008
296 pages, 6 1/8 x 9 1/4
