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Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation
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.
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.
296 pages, Hardcover
First published January 1, 2006
41 people want to read
About the author
Richard A. Epstein
88 books89 followersRichard A. Epstein is the James Parker Hall Distinguished Service Professor Emeritus of Law and Senior Lecturer at The University of Chicago Law School.
Epstein started his legal career at the University of Southern California, where he taught from 1968 to 1972. He served as Interim Dean from February to June, 2001.
He received an LLD, hc, from the University of Ghent, 2003. He has been a member of the American Academy of Arts and Sciences since 1985 and a Senior Fellow of the Center for Clinical Medical Ethics at the University of Chicago Medical School, also since 1983. He served as editor of the Journal of Legal Studies from 1981 to 1991, and of the Journal of Law and Economics from 1991 to 2001.
His books include The Case Against the Employee Free Choice Act (Hoover 2009); Supreme Neglect Antitrust Decrees in Theory and Practice: Why Less Is More (AEI 2007); Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation (Yale University Press 2006); How Progressives Rewrote the Constitution (Cato 2006). Cases and Materials on Torts (Aspen Law & Business; 8th ed. 2004); Skepticism and Freedom: A Modern Case for Classical Liberalism (University of Chicago 2003): Cases and Materials on Torts (Aspen Law & Business; 7th ed. 2000); Torts (Aspen Law & Business 1999); Principles for a Free Society: Reconciling Individual Liberty with the Common Good (Perseus Books 1998): Mortal Peril: Our Inalienable Rights to Health Care (Addison-Wesley 1997); Simple Rules for a Complex World (Harvard 1995); Bargaining with the State (Princeton, 1993); Forbidden Grounds: The Case against Employment Discrimination Laws (Harvard 1992); Takings: Private Property and the Power of Eminent Domain (Harvard 1985); and Modern Products Liability Law (Greenwood Press 1980). He has written numerous articles on a wide range of legal and interdisciplinary subjects.
He has taught courses in civil procedure, communications, constitutional law, contracts, corporations, criminal law, health law and policy, legal history, labor law, property, real estate development and finance, jurisprudence, labor law; land use planning, patents, individual, estate and corporate taxation, Roman Law; torts, and workers' compensation.
Epstein started his legal career at the University of Southern California, where he taught from 1968 to 1972. He served as Interim Dean from February to June, 2001.
He received an LLD, hc, from the University of Ghent, 2003. He has been a member of the American Academy of Arts and Sciences since 1985 and a Senior Fellow of the Center for Clinical Medical Ethics at the University of Chicago Medical School, also since 1983. He served as editor of the Journal of Legal Studies from 1981 to 1991, and of the Journal of Law and Economics from 1991 to 2001.
His books include The Case Against the Employee Free Choice Act (Hoover 2009); Supreme Neglect Antitrust Decrees in Theory and Practice: Why Less Is More (AEI 2007); Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation (Yale University Press 2006); How Progressives Rewrote the Constitution (Cato 2006). Cases and Materials on Torts (Aspen Law & Business; 8th ed. 2004); Skepticism and Freedom: A Modern Case for Classical Liberalism (University of Chicago 2003): Cases and Materials on Torts (Aspen Law & Business; 7th ed. 2000); Torts (Aspen Law & Business 1999); Principles for a Free Society: Reconciling Individual Liberty with the Common Good (Perseus Books 1998): Mortal Peril: Our Inalienable Rights to Health Care (Addison-Wesley 1997); Simple Rules for a Complex World (Harvard 1995); Bargaining with the State (Princeton, 1993); Forbidden Grounds: The Case against Employment Discrimination Laws (Harvard 1992); Takings: Private Property and the Power of Eminent Domain (Harvard 1985); and Modern Products Liability Law (Greenwood Press 1980). He has written numerous articles on a wide range of legal and interdisciplinary subjects.
He has taught courses in civil procedure, communications, constitutional law, contracts, corporations, criminal law, health law and policy, legal history, labor law, property, real estate development and finance, jurisprudence, labor law; land use planning, patents, individual, estate and corporate taxation, Roman Law; torts, and workers' compensation.
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September 13, 2011
This book was so fascinating--even though Epstein takes his arguments to the extreme. Richard Epstein believes that the FDA is overreaching. He believes that most regulations added after 1938 (when the FDA really became the FDA) are superfluous and actually do more harm than good.
As I understand it, the commonly held nomenclature of the industry is that there are two problems with FDA regulation: (1) Type I problems; and (2) Type II problems. A Type I problem is that due to a lack of thorough regulation, harmful drugs get through the FDA approval process and cause deaths or harm to patients. A Type II problem is when the FDA approval process is so thorough that many people end up dying because a drug is, in Epstein's view, unnecessarily languishing in the approval process.
Epstein's arguments are fascinating to read because they are so different from most arguments out there. For example, Epstein believes that we should create some kind of free market "wiki" for FDA approval and regulation of off-label drug use. He envisions a website or collection of websites where physicians and patients self-report their side effects and benefits of drugs which they have been using for off-label uses. Once a critical mass of people report their side effects and benefits, other consumers and doctors can get a sense of the drugs safety for that specific off label use of that particular drug.
Also, Epstein's libertarian philosophy makes him convinced that the best thing the FDA can do is the phase I clinical trial and then abandon the Phase II and Phase III. His reasoning is that once the drug is proven through phase I trials that it won't kill people, that doctors can prescribe the drug as they see fit.
These are interesting arguments--especially since I read Marcia Angell's book immediately prior to reading this one which is on the opposite end of the spectrum and equally extreme.
As I understand it, the commonly held nomenclature of the industry is that there are two problems with FDA regulation: (1) Type I problems; and (2) Type II problems. A Type I problem is that due to a lack of thorough regulation, harmful drugs get through the FDA approval process and cause deaths or harm to patients. A Type II problem is when the FDA approval process is so thorough that many people end up dying because a drug is, in Epstein's view, unnecessarily languishing in the approval process.
Epstein's arguments are fascinating to read because they are so different from most arguments out there. For example, Epstein believes that we should create some kind of free market "wiki" for FDA approval and regulation of off-label drug use. He envisions a website or collection of websites where physicians and patients self-report their side effects and benefits of drugs which they have been using for off-label uses. Once a critical mass of people report their side effects and benefits, other consumers and doctors can get a sense of the drugs safety for that specific off label use of that particular drug.
Also, Epstein's libertarian philosophy makes him convinced that the best thing the FDA can do is the phase I clinical trial and then abandon the Phase II and Phase III. His reasoning is that once the drug is proven through phase I trials that it won't kill people, that doctors can prescribe the drug as they see fit.
These are interesting arguments--especially since I read Marcia Angell's book immediately prior to reading this one which is on the opposite end of the spectrum and equally extreme.
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