In article <[EMAIL PROTECTED]>, Tim
Bedding <[EMAIL PROTECTED]> writes
>Lowell
>
>> Aww Dr. Tame, you're such a hard-liner. :-) I'd go for
>> just privatizing it and allowing competition.
>
>Competition can only improve things if there are
>significant inefficiencies.
>
>This takes us back to searching for a list of identified
>efficiency changes in FDA.
>
>Do you, or Bill, have a proven list?
>

The overwhelming historical and contemporary record of empirical
evidence concerning the inefficiency of all institutions with monopoly
power, and the massive body of scientific economic analysis of why this
is the case, is apparently unknown to Mr. Bedding.

Moreover, the principal objection to the FDA is not simply its
inefficiency, but its very rationale per se. No agency should have the
power to stop companies marketing new drugs to potential customers, so
long as their frank declaration of the degree to which they have been
tested or validated, to prevent customers from purchasing those drugs,
to dictate what information can be purveyed regarding those drugs, to
censor information regarding drugs, or to impose by force its view of
what degree of risk is acceptable to consumers.


For those genuinely interested in the case against the FDA the following
selected bibliography on the Critique of Pharmaceutical Industry
Regulation, excerpted from my forthcoming CNE bibliography on healthcare
and welfare policy, contains material on the FDA::



CHAPTER 38:     THE CRITIQUE OF PHARMACEUTICAL INDUSTRY REGULATION

An influential stream of academic thought and political policy
throughout the western world expresses great hostility to the
pharmaceutical industry and to the profit motive, emphasises the risks
of pharmaceutical innovations and the need for a high degree of
regulation, or seeks to minimise health care costs by limits upon the
range of permissable products to be utilised by doctors. The following
works offer detailed critiques of all these positions.  I have selected
only the more accessible works, rather than the huge technical economic
literature on these subjects. 

There is also a large and growing body of literature specifically on the
American evidence regarding the counterproductive effects of the Food
and Drug Agency's (FDA) regulation of pharmaceuticals. I have included a
selection from this material.

Anderson, William (23 May 2000), "The Politics of Medical Research",
Mises.org, at: http://www.mises.org/fullarticle.asp?control=432&id=65
A brief critique of Marcia Angell's "The Pharmaceutical Industry - To
Whom Is It Accountable", in The New England Journal of Medicine.
(March 2002), "Prescription Drugs and Advertising", The Freeman
Foundation for Economic Education)â 52(3); at:
http://www.fee.org/vnews.php?nid=5384
A demolition of the economically illiterate article by the
anthropologist Ellen Goodman, "Prescription Drug Ads Drive Up Costs." 

Anon. (9 August 1999), "The Other War on Drugs", Research Reports
(American Institute for Economic Research, Great Barrington, Mass.),
LXVI(15), pp. 87-88

Anon. (September 2000), "Economic Common Sense About Prescription
Drugs", Economic Education Bulletin (American Institute for Economic
Research, Great Barrington, Mass.), XL(9), pp. 1-4

Anon., Accounting 101: Misreprsentation of Pharmaceutical Profits,
Policy Note No 2, Buickee Institute for Public Policy Solutions, 4100
North High Street, Suite 200, Columbus, Ohio 43214, 2002

Bailey, Ronald (Spring 2001), "The New Global Villains: Drug Companies
and âObscene Profitsâ", Policy (Centre for Independent Studies, St.
Leonards, New South Wales); at:
http://www.cis.org.au/policy/Spring01/PolicySpring01_2.html
(January 9, 2002), "Timid Bureaucrats Kill People: The FDA is Past its
Expiration Date in a World of Gene Therapies", Reason (Los Angeles), at:
http://reason.com/rb/rb010902.shtml
(11 June 2003), "Senioritis: Drug Price Controls Just a Few Years Away",
Reason (Los Angeles); at:
http://www.reason.com/links/links061103.shtml
(24 September 2003), "Snake Oil or Health Tonic: What the FDA Doesnât
Want You To Know About Dietary Supplements", ReasonOnline;  at:
http://www.reason.com/rb/rb092403.shtml

Bandow, Doug (February 1994), "The Pharmaceutical Industry: Problem or
Solution?", The Freeman (Foundation for Economic Education), 44(2), pp.
55-60; at: http://www.fee.org/vnews.php?nid=2855
(February 1996), "Increasing Access to Pharmaceuticals", The Freeman
(Foundation for  Economic Education), 46(2), pp. 93-98; at:
http://www.fee.org/vnews.php?nid=3403
Also at:
http://www.libertyhaven.com/politicsandcurrentevents/healthcarewelfareor
socialsecurity/increacphar.shtml
(11 November 1996), "The FDA Can Be Dangerous To Your Health", Fortune
(New York)
(3 October 2000), "How a Pharmaceutical âCrisisâ Was Created",  Jewish
World Review, at:
http://www.jewishworldreview.com/cols/bandow100300.asp
(September 2000), "Bipartisan Drug Entitlement", The Freeman (Foundation
for Economic Education), 50( 9); at: 
http://www.fee.org/vnews.php?nid=4727
Also at:
http://www.libertyhaven.com/politicsandcurrentevents/healthcarewelfareor
socialsecurity/bipartisandrug.shtml 
(December 2000), "The Faux Pharmaceutical Crisis: Market Incentives vs.
Government Mandates", The State Factor (American Legislative Exchange
Council), 25(2); at: http://www.alec.org/
(22 May, 2002), "Threatening Pharmaceutical Innovation", Townhall.com,
at:
http://www.townhall.com/columnists/dougbandow/db20020522.shtml
(21 December, 2002), "Health-Care Demagogues", Townhall.com,  at:
http://www.townhall.com/columnists/dougbandow/db20021231.shtml
(18 March 18, 2003), "Demonizing Those Who Cure Us", Townhall.com,  at:
http://www.townhall.com/columnists/dougbandow/db20030318.shtml
(7 July, 2003 ), "Politics Enough to Make Drug Companies Sick",
Townhall.com,  at:
http://www.townhall.com/columnists/dougbandow/db20030707.shtml
Drug Companies: The Health Care Bogeyman, Viewpoint on Public Issues,
No. 94-08, Mackinac Centre, Midland, Michigan, 4  April 1994; at:
http://www.mackinac.org/article.asp?ID=130
Demonising Drugmakers: The Political Assault on the Pharmaceutical
Industry, Policy Analysis No. 475, Cato Institute, Washington, DC, 2004;
at: http://www.cato.org/pubs/pas/pa-475es.html

Bast, Joseph L., Mr. President, Don't Mess With Drug Pricing, Heartland
Institute, Palatine, Illinois, 1994

Becker, Gary (September 2002), "Get the FDA Out of the Way, and Drug
Prices Will Drop,  Business Week (New York)

Beesley, M. (1992), "Schumpeter and UK Pharmaceuticals", Teeling Smith,
George, ed., Innovative Competition in Medicine: A Schumpetarian
Analysis of the Pharmaceutical Industry and the NHS,  Office of Health
Economics, London 

Berlau, John, FDA Censors Crucial Information About Alzheimer's Drug,
Consumer Alert, at:
http://www.consumeralert.org/issues/health/alzheim.htm

Block, Walter (February 1990), "Stop the Drug Profiteers?", Fraser Forum
(Fraser Institute),  pp. 23-24
& Walker, Michael A. (1989), "Drug Patents", Idem, Lexicon of Economic
Thought, Fraser Institute, Vancouver, pp. 106-108

Boston Consulting Group, The, Ensuring Cost-Effective Access to
Innovative Pharmaceuticals: Do Market Interventions Work?, Boston
Consulting Group, Inc., on behalf of Warner-Lambert Company, April,
1999, at:
http://www.warner- lambert.com/pricecontrolsstudy/study_landing.html

Bovard, James B. (1995), "End FDA Suppresion of Drug Information",
Consumerâs Research (New York), 7(1); at:
http://www.acsh.org/publications/priorities/0701/suppression.html

Brimelow, Peter & Spencer, Leslie (22 November 11993), "Food and Drugs
and Politics", Forbes (New York)

Brozen, Yale, The American Drug Industry: Private Enterprise or Public
Utility?, Reprint No. 79, American Enterprise Institute, Washington, DC,
1977

Burstall, Mike L., 1992 and the Regulation of the Pharmaceutical
Industry, Health Series 9, IEA Health & Welfare Unit, Institute of
Economic Affairs, London, 1990 
& Reuben, B. G., Critics of the Pharmaceutical Industry, REMIT
Consultants, London, 1990
& Senior, Ian S. T., Undermining Innovation: Parallel Trade in
Prescription Medicines, Choice in Welfare No. 13, IEA Health & Welfare
Unit, Institute of Economic Affairs, London, 1992

Cady, John, Drugs on the Market: The Impact of Public Policy on the
Retail Market for Prescription Drugs, D. C. Heath, Lexington, Mass.,
1975 
Restricted Advertising and Competition: The Case of Retail Drugs,
American Enterprise Institute, Washington, DC, 1976

Caglarcan, Erol et al, eds., The Pharmaceutical Industry: Economics,
Performance and Government Regulation, John Wiley, New York, 1978

Calfee, John E. (February 2001), "Itâs Time for Canada to Rethink its
Ban on Direct-to-Consumer Advertising of Prescription Drugs", Fraser
Forum, (Fraser Institute); at:
http://www.fraserinstitute.ca/admin/books/chapterfiles/It%20Is%20Time%20
for%20Canada%20to%20Rethink%20its%20Ban%20on%20Direct-to-Consumer%20Adve
rtising%20of%20Prescription%20Drugs-feb01ff(v8).pdf#4
A Primer on FDA Reform, American Enterprise Institute, Washington, DC,
1996
Why Pharmaceutical Price Controls Are Bad for Patients, On the Issues,
American Enterprise Institute, Washington, DC, 1999; at:
http://www.aei.org/publications/pubID.10059/pub_detail.asp
Prices, Markets and the Pharmaceutical Revolution, American Enterprise
Institute, Washington, DC, 2000; at:
http://www.aei.org/publications/filter.,bookID.196/book_detail.asp
A comprehensive account of the enormous progress made in pharmaceutical
discovery, myths regarding the sources of drug expenditures in medical
care, and the disastrous effects upon innovation of coercive price
controls upon drugs.
The Grim Economics of Pharmaceutical Importation, Health Policy Outlook,
American Enterprise Institute, Washington, DC, 2003; at:
http://www.aei.org/publications/pubID.19380,filter./pub_detail.asp
The High Price of Cheap Drugs, On the Issues, American Enterprise
Institute, Washington, DC, 2003
Pharmaceutical Price Controls: Testimony Before House Committee on
Indistrial Relations, State of Georgia, American Emterprise Institute,
New York, 2004; at:
http://www.aei.org/news/newsID.19930,filter./news_detail.asp

Campbell,  Noel C. (2000), "Exploring Free Market Certification of
Medical Devices", Feldman, Roger D., ed., American Health Care:
Government, Market Process and the Public Interest, Independent
Institute, Oakland, Calif.
Making Drugs Safe and Available Without the FDA, Policy Report No. 208,
National Centre for Policy Analysis, Dallas, Texas, 1997

Campbell, Rita-Ricardo (1982), "Risk-Benefit, Cost-Benefit: Improving
Government Regulation of Approval of New Drugs", Gaag, J. Van Der, et
al, eds., Economics of Health Care, Praeger, New York

Cardy, Peter et al, Keeping Patients in the Dark: Should Prescription
Medicines Be Advertised Direct to Consumers?, IEA Health and Welfare
Unit, London, 1999

Copulos, Milton (March 1985), "It's Effective - But Is it Safe?", Reason
(Los Angeles), 16(10), pp. 24-32

Commanor, W. S. (September 1986), "The Political Economy of the
Pharmaceutical Industry", Journal of Economic Literature
 
Conko, Gregory, A National Survey of Neurologists and Neurosurgeons
Regarding the Food and Drug Administration, Monograph, Competitive
Enterprise Institute, Washington, DC, 1998

Cooper, Joseph D., ed., The Economics of Drug Innovation, The American
University, Washington, DC, 1969
ed., Regulation, Economics and Pharmaceutical Innovation, The American
Uni-versity, Washington, DC, 1976

Crowner, Robert (15 May 2002), "Drug Pricing vs. Drug Development",
Acton Commentary, Acton Institute, Grand Rapids, Michigan

Danzon, Patricia M. (April 1998), "Can Pharmaceutical Price Regulation
and Innovation Co-Exist?", Fraser Forum (Fraser Institute), pp. 24-27 
(Spring 2000), "Making Sense of Drug Prices", Regulation, 23(1), pp.
56-63; at: http://www.cato.org/pubs/regulation/regv23n1/danzon.pdf
Pharmaceutical Price Regulation: National Policies Versus Global
Interests, American Enterprise Institute, Washington, DC, 1996
Prices, Competition and Regulation in Pharmaceuticals: A Cross-National
Comparison, Office of Health Economics, London, 2000
The Life Cycle of Pharmaceuticals: A Cross-National Perspective, Office
of Health Economics, London, 2002

DeFalco, Julie, The FDA vs Reform, Monograph, Competitive Enterprise
Institute, Washington, DC, 1996

DiMasi, J. et al (1991), "Cost of Innovation in the Pharmaceutical
Industry", Journal of Health Economics, 10, PP. 107-42

Doherty, Brian (nd), "Malignant Law Enforcement : The FDA's War Against
an Unorthodox Cancer Doctor", Reason (Los Angeles), at: 
http://reason.com/9705/fe.brian.shtml

Drummond, M. et al, Economic Evaluation in the Development of Medicines,
Office of Health Economics, London, 1988

Dunn, Wayne (10 December 2002), "Capitalism is the Best Medicine",
Capitalism Magazine, at: http://capmag.com/article.asp?ID=2180

Edmonds, Brad (15 November 2003), "The FDA Wants You To Tell It How To
Tell You What To Do", LewRockwell.com, at:
http://www.lewrockwell.com/edmonds/edmonds155.html

Eisman, Martin M., et al, Economic Costs of FDA Regulations: A Set of
Studies of Some Economic Effects of Food and Drug Administration
Regulation of Human Pharmaceuticals, Symposia Series CS-10, Centre for
Research in Government Policy & Business, Graduate School of Management,
University of Rochester, 1981

Epstein, Alex (17 February 2005), "Drug Safety vs. the FDA", The Ayn
Rand Institute (Irvine, Calif.), at:
http://www.aynrand.org/site/News2?page=NewsArticle&id=10859

Esposito, Scott (25 November 2000), "Off-Label Prescribing of Drugs
Calls FDA Role Into Question", Independent Institute, Oakland,
California, at: http://www.independent.org/tii/news/001125Esposito.html

Evans, M. Stanton (June 1975), "Government Can Be Hazardous to Your
Health", Imprimis (Hillsdale College), 4(6), pp. 1-6

Fairweather, Diane B. & Hindmarch, Ian, False Economies: The True Cost
of 'Cheap' Drugs, Risk Controversies 4, Social Affairs Unit, London,
1995

Foulkes, Arthur E. (March 2003), "Ton of Prevention: How the FDA
Threatens Vaccine Supplies", The Freeman (Foundation for Economic
Education), 53(3); at: http://www.fee.org/~web/0303iolpdf/feat8.pdf

Frech, III, H. E. & Miller, Jr., Richard D., The Productivity of Health
Care and Pharmaceuticals: An International Comparison, American
Enterprise Institute Press, Washington, DC, 1999

Fumento, Michael (June 1995), "Sponge Bath: How the FDA Squeezes Women's
Choices", Reason (Los Angeles), at:
http://www.fumento.com/sponge.html
(1997), "Kesslerâs Kids", at:
http://www.fumento.com/bomis3.html
Anorther example of FDA coercion and causeless alarmism.
(1996), "FDA Screwing Around with Device Approval", at:
http://www.fumento.com/fda.html 
(1996), "Profiting from Blasting Drug Company Profits", at: http://www.f
umento.com/bomis22.html 
(May 29, 2000), "Prescription for Trouble ", Forbes (New York), at:
http://www.fumento.com/drugs.html 
(25 September 2000),  "Goring Drug Companies: A Plan That Doesn't Help
the Elderly", National Review Online, at:
http://www.fumento.com/gorecampaign.html
(31 October 2001), "Bayer's Headache: U.S. Government Uses Heavy Hand
For Cheap Cipro", Investor's Business Daily (New York), at:
http://www.fumento.com/ibdhallow.html
(June 3, 2004), "Drug Studies as Phony as Sugar Pills", Scripps Howard
News Service, at:
http://www.fumento.com/disease/medicine.html
The above five essays demolish various campaign against drug companiesâ
profits.
FDA Screwing Around with Device Approval, Consumer Alert, nd, at:
http://www.consumeralert.org/fumento/fdascrew.htm
Profiting from Blasting Drug Company Profits, Consumer Alert, nd, at:
http://www.consumeralert.org/fumento/drugs.htm

Ghate, Onkar (24 July 2002), "Prescription Drug Benefits Violete the
Rights of Drug Companies", Capitalism Magazine, at:
http://capmag.com/article.asp?ID=2021
Also at:
http://www.aynrand.org/site/News2?JServSessionIdr008=94cm4szq31.app14b&p
age=NewsArticle&id=5367&news_iv_ctrl=1073

Giaccotto, Carmelo et al, Explaining Pharmaceutical R&D Growth Rates,
THE AEI-Brookings Joint Centre for Regulatory Studies, Washington, DC,
2004, at:
http://aei-brookings.org/publications/abstract.php?pid=414

Gieringer, Dale H. (Spring/Summer 1985), "The Safety and Efficacy of New
Drug Approval", Cato Journal, 5(1), pp. 177-201; at:
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Consumer Choice and FDA Drug Regulation, Ph.D. Dissertation,  Department
of Engineering-Economic Systems, Stanford University, California, 1984
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Goldberg, Robert (1995), "Breaking Up the FDA's Medical Information
Monopoly," Regulation (Cato Institute), No. 2, pp. 44-52
Pharmaceutical Price Controls: Saving Money Today or Lives Tomorrow?,
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(http://www.ipi.org/), Lewisville, Texas, 1993
Speak No Good: The Tragedy of FDA Gag Rules, Brief Analysis No. 214,
National Centre for Policy Analysis, Dallas, Texas, 1996
David Kessler's Legacy at the FDA, Policy Report No. 143, Institute for
Policy Innovation (http://www.ipi.org/), Lewisville, Texas, 1997
Ten Myths About the Market for Prescription Drugs, Policy Report No.
230, National Centre for Policy Analysis, Dallas, Texas, 1999
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Balance, Manhattan Institute, Washington, DC, June 3, 2002; at:
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Gottlieb, Scott (1 December 2002), "FDA Rules Hinder Cancer Vaccines",
On the Issues (American Enterprise Institute); at:
http://www.aei.org/publications/pubID.32,filter./pub_detail.asp

Grabowski, Henry G., Drug Regulation and Innovation: Empirical Evidence
and Policy Options, Evaluative Studies 28, American Enterprise
Institute, Washing-ton, DC., 1976
Health Reform and Pharmaceutical Innovation, Special Studies in Health
Reform, American Enterprise Institute, Washington, DC, 1994
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Ethical Drugs", American Economic Review
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Studies No. 377, American Enterprise Institute, Washington, DC, 1983

Graham, John R. (February 2001); "Pharmaceutical Potency", Fraser Forum
(Fraser Institute); at:
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for%20Canada%20to%20Rethink%20its%20Ban%20on%20Direct-to-Consumer%20Adve
rtising%20of%20Prescription%20Drugs-feb01ff(v8).pdf#8
(October 2001), "Saving Money With Generic Drugs", Fraser Forum (Fraser
Institute), pp. 28-30
(March 2002), "Pharmaceutical Advertising is the Right Prescription
Control", Fraser Forum (Fraser Institute), pp. 34-35
(September 2002), "Why the Difference Between Canadian and American
Prices for Prescription Drugs Is Widening", Fraser Forum (Fraser
Institute), pp. 32-34
(March 2003), "Increased Drug R&D Through Increased Promotion", Fraser
Forum (Fraser Institute), pp. 28-29
(April 2003), "Drug Costs: Patents Are Not the Problem", Fraser Forum
(Fraser Institute), pp. 28-29
(May 2003), "A National Drug Agency Will Not Contain Drug Costs", Fraser
Forum (Fraser Institute), pp. 26-27
(October 2003), "Patents are Better than Prizes or Public Investment for
Medical Innovation", Fraser Forum (Fraser Institute), pp. 24-26
Prescription Drug Prices in Canada and the United States - Part 1: A
Comparative Survey, Policy Source No. 42, Fraser Institute, Vancouver,
2000; at:
http://www.fraserinstitute.ca/shared/readmore.asp?sNav=pb&id=160
Prescription Drug Prices in Canada and the United States - Part 2: Why
the Difference?, Policy Source No. 43, Fraser Institute, Vancouver,
2000; at:
http://www.fraserinstitute.ca/shared/readmore.asp?sNav=pb&id=161
Prescription Drug Prices in Canada and the United States - Part 3:
Retail Price Distribution, Policy Source No. 50, Fraser Institute,
Vancouver, 2001; at:
http://www.fraserinstitute.ca/shared/readmore.asp?sNav=pb&id=202
Prescription Drug Prices in Canada and the United States  - Part 4:
Canadian Prescriptions for American Patients Are Not the Solution,
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http://www.fraserinstitute.ca/shared/readmore.asp?sNav=pb&id=526
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And at:
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socialsecurity/govkillpeople.shtml
(1994), "For Safety's Sake the Government Must Regulate the Market for
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How FDA Is Causing a Technological Exodus: A Comparative Analysis of
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Inde-pendent Institute, Oakland, California, 1995

Hiller, Stephanie (September 1994), "FDA and the Market in Natural
Medicine", The Freeman (Foundation for Economic Education), 44(9); at:
http://www.fee.org/vnews.php?nid=3000
Also at:
http://www.libertyhaven.com/politicsandcurrentevents/healthcarewelfareor
socialsecurity/fdamarket.shtml

Homsy, Charles A., How FDA Regulation and Injury Litigation Cripple the
Medical Device Industry, Policy Review No. 412, Cato Institute,
Washington, DC, 2001

Independent Institute, The, A Guide to Resources on Price Controls in
Health Care, at:
http://www.independent.org/tii/Research/GuideHealthCareIssues.html. 
An excellent website featuring much valuable material on the disastrous
effects of attempts to impose price controls on medical services and
products, especially pharmaceuticals.
An Open Letter from 539 Economists from All 5:0 States on Health Care
Policy Reform, Independent Institute, Oakland, Calif., 2000; at
http://www.independent.org/ 
A  protest against President Clinton's proposals to impose price
controls upon pharmaceuticals

International Society for Individual Liberty, The, Death Through
Regulation: The Price We Pay for the FDA, International Society for
Individual Liberty, San Francisco, nd

Jones, Laura (February 2002), "Can the Drug Approval Process be Reformed
to Save Lives?", Fraser Forum (Fraser Institute), pp. 14-16

Kaplar, Richard T., ed., Bad Prescription for the First Amendment: FDA
Censorship of Drug Advertisng and Promotion, Media Institute,
Washington, DC, 1993

Kazman, Sam (September 1990), "Deadly Overcaution: FDA's Drug Approval
Pro-cess", Journal of Regulation and Social Cost, 1(1), pp. 35-54
(1992), "Saying Yes to Drugs", Policy Analysis, National Chamber
Foundation, Washington, DC
(23 April 1996), "Nailed by FDA", Washington Times; reprinted as a
Monograph, Competitive Enterprise Institute, Washington, DC, 1996
The Food and Drug Administration: A Modest Proposal, Consumer Alert, at:
http://www.consumeralert.org/issues/health/fda_br.htm
Cardiac and Cancer Specialists on the Need for FDA Reform, Monograph,
Competitive Enterprise Institute, Washington, DC, 1998

Kinsky, Lynn (1970), "The Impact of FDA Regulation on Drug Research in
America Today", Reason (Los Angeles), 2(9), pp. 6-12

Klein, Daniel B. (Spring 2000), "Policy Medicine Versus Policy Quackery:
Economists Against the FDA", Knowledge, Technology, and Policy, 13, pp.
92â101
(30 August 2000), "Economists Against the FDA", The Independent
Institute, Oakland, California, at:
http://www.independent.org/tii/news/000900Klein.html
(September 2000), "Economists Against the FDA", The Freeman (Foundation
for Economic Education), 50(9); at:
http://www.fee.org/vnews.php?nid=4725
Also at:
http://www.libertyhaven.com/politicsandcurrentevents/healthcarewelfareor
socialsecurity/econoagainstfda.shtml
& Tabarrok, Alexander (February 25, 2003), "Off-Label Drug Awareness
Saves Lives", Independent Institute, Oakland, California, at:
http://www.independent.org/tii/news/030225Tabarrok.html
Do Off-Label Drug Practices Argue Against FDA Efficacy Requirements?:
Testing An Argument by Structured Conversations With Experts, Working
Paper No. 47, Independent Institute, Oakland, California, 16 April 2003;
at:
http://www.independent.org/tii/WorkingPapers/Klein.pdf
To Americaâs Health: A Proposal to Reform the Food and Drug
Administration, Hoover Institution Press, Stanford, Calif., 2001

Kling, Arnold (19 August 2004), "Self-Righteous Prescription",
TechCentralStation, at:
http://www.techcentralstation.com/081904H.html
A good critique of the socialist claptrap exponded by former New England
Journal of Medicine Editor, Dr. Marcia Angell, in her book  The Truth
About the Drug Companies.

Kogan, Richard Jay (14 December 1998), "Do Drugs Cost Too Much? Consider
the Alternatives", Wall Street Journal (New York)

Kraus, Michael, Breaking the FDA's Drug Approval Monopoly, Monograph,
Competitive Enterprise Institute, Washington, DC, 1996

Landau, Richard, ed., Regulating New Drugs, Centre for Policy Study,
University of Chica-go, 1973

Larson, Elizabeth (April 1992), "Unequal Treatment", Reason (Los
Angeles), 23(11), pp. 48-50. On FDA restrictions on Alzheimer's
treatments.

Lasagna, Louis (Spring 1969), "Congress, the FDA and New Drug
Development: Before and After 1962", Perspectives in Biology and
Medicine, 32, pp. 322-343
International Drug Regulation, Reprint 73, American Enterprise
Institute, Washington, DC, 1977

Lichtenberg, Frank R. (February 2003), "The Health and Economic Benefits
of New Drugs", Fraser Forum (Fraser Institute), pp. 10-12

Lippert, Owen & McArthur, William (June 1997), "Drugs and Intellectual
Property Rights", Fraser Forum (Fraser Institute), pp. 22-24

Looney, William, Drug Budgets: The Hidden Costs of Control, Centre for
the New Europe, Zellik, Belgium, April 1996

Lucas, David (October 1993), "The Political Economy of the
Pharmaceutical Industry: Profits, Production and Pricing Policy", Public
Policy Review (London), 1(2), pp. 23- 24, 26-28 

McArthur, Bill (1988), "Controlling Drug Costs", Fraser Forum (Fraser
Institute), pp. 19-22. A shorter version of his paper below.
(October 1998), "Does the Pharmaceutical Industry Produce Health and
Econo-mic Benefits?", Fraser Forum (Fraser Insitute), pp. 24-25
(November 1998), "Are Brand Name Drugs Too Expensive?", Fraser Forum
(Fraser Institute), pp. 14-15
(March 1999), "Medical Research is a Matter of Economic Self Interest",
Fraser Forum (Fraser Institute), pp. 32-33
Pharmaceutical Cost Containment: A Canadian Dilemma, Fraser Institute,
Vancou-ver, 1997

Manning, Richard L. (April 1997), "Products Liability and Prescription
Drug Prices in Canada and the United States", Journal of Law and
Economics (University of Chicago), 40(1), pp. 203-43

Matthews Jr., Merrill (26 June 2000), "Want to Stifle Drug Innovation?
Posture, Impose Price Controls", Investorâs Business Daily
(7 October 2001), "Drug Companies: Saving Lives, Making Money",
Capitalism Magazine, at: http://capmag.com/article.asp?ID=1134
Answering Critics of Pharmaceutical Patents, IPI Ideas No. 17, Institute
for Policy Innovation, Lewisville, Texas, 2003, at: http://www.ipi.org/

Meehan, Jr., James W. (17 April 2001), "Drug Price Controls Will Hurt
Consumers", Independent Institute, Oakland, California, at:
http://www.independent.org/tii/news/010417Meehan.html

Miller, MD, Henry I. (1998), "Failed FDA Reform", Regulation (Cato
Institute), 21(3), pp. 24-30; at:
http://www.cato.org/pubs/regulation/regv21n3/v21n3-ftr2.pdf
(November 2002), "Why It Takes a Village (To Afford a Prescription)",
AEI-Brookings Joint Centre for Regulatory Studies (Washington, DC),
Policy Matters 02-51; at:
http://www.aei.brookings.org/policy/page.php?id=120
Policy Controversey in Biotechology: An Insiderâs View, Academic Press
for R. G. Landes, Austin, Texas, 1997
To America's Health: A Proposal to Reform the Food and Drug
Administration, Hoover Institution Press, Stanford, California, 2000. A
good analysis of the deadly over-caution of the FDA, but weak in its
reformist propsals.

Pelzman, Sam (Spring 2001), "Millerâs Prescription", Reguation (Cato
Institute), 24(1), pp. 56-57; at: 
http://www.cato.org/pubs/regulation/regv24n1/inreview.pdf
***

Miller, Roger L., Economic Issues for Consumers, West Publishing, St.
Paul, Minnesota, 1975 

Mitchell, Daniel (June 1992), "The Deadly Impact of Federal
Regulations", Journal of Regulation and Social Costs

Mitchell, Samuel A. & Link, Emery A., eds., Impact of Public Policy on
Drug Innovation and Pricing, The American University, Washington, DC,
1976

Mitra, Barun (27 January 2005), "Mis-diagnosing the Disease of the Poor:
Itâs Not Patents but the Government Hold on the Healthcare Sector that
is Preventing the Poor from Gaining Access to Medicines", The Indian
Express (New Delhi), at: http://www.indianexpress.com/full_story.php?con
tent_id=63547

Moore, Stephen D. (21 July 2000), "In Drug Cost Debate, Europe Offers US
a Telling Side Effect", Wall Street Journal (New York)

More, Max (May 1995), "Live Freely, Live Longer", The Freeman Foundation
for Economic Education), 45(5); at:
http://www.fee.org/vnews.php?nid=3167

Neal, Mark, Keeping Cures From Patients: The Perverse Effects of
Pharmaceutical Regulations, Risk Controversies No. 6, Social Affairs
Unit, London, 1995

Paul, MD, Representative Ron (24 July 2003), "Free Trade in
Pharmaceuticals", LewRockwell.com, at:
http://www.lewrockwell.com/paul/paul115.html
(5 August 2003), "Drug Reimportation Increases Medical Freedom",
LewRockwell.com, at: http://www.lewrockwell.com/paul/paul119.html 

Pearson, Durk & Shaw, Sandy (nd), "FDA TKO", Liberty (Port Townsend,
Washington), at:
http://www.libertysoft.com/liberty/features/72pearsonshaw.html
An account of the authorsâ successful litigation against the FDA that
forced it to redesign its unconstitutional restrictions on product
labeling.
Freedom of Informed Choice: FDA Versuis Nutrient Supplements, Common
Sense Press, Neptune, New Jersey, 1993

Peltzman, Sam (1973), "The Benefits and Costs of New Drug Regulation",
in Landau, Richard L., ed., Regulating New Drugs, University of Chicago
Centre for Drug Policy, 1973, pp. 113-211
(September-October 1973), "An Evaluation of Consumer Protection
Legislation: The 1962 Drug Amendments", Journal of Political Economy
(University of Chicago), 81(5), pp. 1049-91; also reprinted in Landau
(1973), op cit, above, pp. 9-20, and in Stigler, George J., ed., Chicago
Studies in Political Economy, University of Chicago Press, 1988, pp.
303-48
(1987), "The Health Effects of Mandatory Prescriptions", Journal of Law
and Economics, 30(2), pp. 207-38
Regulation of Pharmaceutical Innovation: The 1962 Amendments, Evaluative
Studies 15, American Enterprise Institute, Washington, DC, 1974

Pipes, Sally C. & Zycher, Benjamin (28 September 2004), "Where This
Angell Should Have Feared to Tread", TechCentralStation, at:
http://www.techcentralstation.com/092804D.html
A further critique of the socialist claptrap exponded by former New
England Journal of Medicine Editor, Dr. Marcia Angell, in her book  The
Truth About the Drug Companies.

Pollard, Stephen (February 2003), "Pharamaceutical R&D Jeopardised in
the EU", Fraser Forum (Fraser Institute), pp. 17-19 

Plummer, James (May 2000), "FDA's Pediatric Rule Restricts Access to
Medicine", Consumers' Research Magazine, at:
http://www.consumeralert.org/pubs/research/CRMay00.htm

Quirk, Paul J. (1980), "Food and Drug Administration", Wilson, James Q.,
ed., The Politics of Regulation, Basic Books, New York

Ralston, Richard E. (September 19, 2003), "Free Markets: The Key to New
Drugs at a Reasonable Price", Americans for Free Choice in Medicine, at:
http://afcm.org/freemarketskey.html

Redwood, Dr. Heinz, The Price of Health: The Link Between Research in
the Pharmaceu-tical Industry and Health Care Systems in the Developed
World, Adam Smith Institute, London, 1989.  Deals with the detrimental
effects of EU regulations on innovations in pharma-ceutical treatments.

Reekie, W. Duncan (March 1978), "Price and Quality Competition in the
United States Drug Industry", Journal of Industrial Economics, 26(3),
pp. 223-237 
(June 1984), "Drug Prices in the UK, USA, Europe and Australia",
Australian Economic Papers, pp. 71-78
(1984), "Pharmaceutical Pricing and Profits", Wells, N., ed., The Second
Pharmacological Revolution, Office of Health Economics, London, pp.
198-209
(1997), "Cartels, Spontaneous Price Discrimination and Pharmacy
Retailing", International Journal of Economics and Business, 4;
reprinted as Occasional Paper No. 9, Free Market  Foundation, Cape Town,
2001
The Economics of the Pharmaceutical Industry, Macmillan, London, 1975
Pricing New Pharmaceutical Products, Croom Helm, London, 1976
Price Comparisons of Identical Products in Japan, the United States and
Eur-ope, Office of Health Economics, London, 1981  
Prescribing the Price of Pharmaceuticals, Choice in Welfare 26, IEA
Health & Welfare Unit, Institute of Economic Affairs, London, 1995
Medicine Prices and Innovations, Choice in Welfare Series No. 30,
Institute of Economic Affairs, London, 1996
Competition Lowers the Costs of Medicines for Consumers, Briefing Paper
26, Free Market Foundation, P. O. Box 785121, 2146 Sandton, South
Africa, 1997
Medicine Prices and Innovations: An International Survey, Choice in
Welfare 30, IEA Health & Welfare Unit, Institute of Economic Affairs,
London, 1996
& Otzbrugger, Hans G., Competition and Home Medicines, Research
Monograph 39, Institute of Economic Affairs, London, 1985. On the
ineffectiveness of at-tempts to limit the British NHS drugs bill, and a
call for the removal of restrictions on home medicines and their sale.
& Weber, M., Profits, Politics and Drugs, Macmillan, London/Holmes &
Meier, New York, 1979

Ricardo-Campbell, Rita, Drug Lag: Federal Government Decision Making,
Study 55, Hoover Institution Press, Stanford University, California
94305, 1976
Risk-Benefit/Cost-Benefit: Improving Government Regulation of Approval
of New Drugs, Hoover Institution, Stanford University, California, 1980
Measurement of the Benefits of Drugs, Reprint Series 55, Hoover
Institution, Stanford  University, Stanford 94305, California 94305,
USA, 1982

Roberts, John (1966), "Economics and the Pharmaceutical Industry", The
Business Economist (Society of Business Economists, Watford), 27(2), pp.
17-31

Roberts, Russell (September 1999), "A World Without the FDA", The
Freeman (Foundation for Economic Education), 49(9); at:
http://www.fee.org/vnews.php?nid=4436

Roll, G. Frederick, Of Politics and Drug Regulation, PS-7701, Centre for
the Study of Drug Development, Rochester, New York, 1977

Rose, Morgan (26 November 2001), "Patent Laws and the War on Good
Drugs", Library of Economics and Liberty, Liberty Fund, at:
http://www.econlib.org/library/Columns/Teachers/patent.html

Ross, Walter R., The Life/Death Ratio, Readerâs Digest Press, New York,
1977

Rubin, Paul H. (1991), "Economics of Prescription Drug Advertising",
Journal of Research in Pharmaceutical Economics, 3, pp.  29â41
(Winter 1991), "The Economics of Regulating Deception", Cato Journal,10,
pp. 667â90; at:
http://www.cato.org/pubs/journal/cj10n3/cj10n3-4.pdf
(1994), "Do Pharmaceutical Ads Deceive?", Food and Drug Law Journal,
49, pp. 7â19
(1995), "FDA Advertising Restrictions: Ignorance Is Death", Higgs,
Robert, ed., Hazardous to Our Health?: FDA Regulation of Health Care
Products, Inde-pendent Institute, Oakland, California, pp. 29-53
(7 November 1995), "The Health Risk of Censorship: FDAâs Advertising
Regulations Cost Lives!", Independent Institute, Oakland, California,
at:
http://www.independent.org/tii/news/951107Rubin.html
(27 June 2000), "The New England Journal of Medicine - To Whom Is It
Accountable?", Independent Institute, Oakland, Calif., at:
http://www.independent.org/tii/news/000627Rubin.html
An excellent brief critique of the economic illiteracy and statist
proposals of Marcia Angell's "The Pharmaceutical Industry - To Whom Is
It Accountable", in The New England Journal of Medicine.

Ruwart, Mary J. (1992), "Protecting Ourselves to Death", Idem, Healing
Our World: The Other Piece of the Puzzle, SunStar Press, Kalamazoo,
Michigan, pp. 71-84
Death By Regulation: The Price We Pay for the FDA, International society
for Individual Liberty, Benicial, Calif., 1990; rev edn, 1999;
at::http://www.isil.org/resources/lit/death-regulation.html

Scherer, F. M. (1993), "Pricing, Profits and Tchnological Progress in
the Pharmaceutical Industry", Journal of Economic Perspectives, 7, pp.
97-115
(September/October 2001), "The Link Between Gross Profitability and
Pharmaceutical R&D Spending", Health Affairs, pp. 216-220, at:
http://www.healthaffairs.org/archives_library.htm

Schlesinger, Stevern R. & Boitan, James J. (Fall 1978), "Regulatory
Prohibition: The FDA as Omniscient Guardian", Intercollegiate Review
(Intercollegiate Studies Institute), 14(1), pp. 43-50; and also at:
http://www.mmisi.org/ir/14_01/schlesinger.pdf

Stuge, R. B. (1969), "Regulation of Drug Advertising: Medical Progress
and Private Enterprise", Havighurst, Clark C., ed., Medical Progress and
the Law, Oceana Publications, Dobbs Ferry, New York

Seidmann, David (July/August 1977), "The Politics of Policy Analysis:
Protection or Overpro-tection in Drug Regulation?", Regulation (Cato
Institute), pp. 22-37

Schwartzman, David, Innovation in the Pharmaceutical Industry, Johns
Hopkins Press, Baltimore, 1973
The Expected Return From Pharmaceutical Research: Sources of New Drugs
and the Profitability of Research and Development Investment, Evaluative
Studies 19, American Enterprise Institute, Washington, DC, 1975

Shulman, S. R. & Lasagna, Louis, eds., Pricing and Reimbursement of
Pharmaceuticals: An Evaluation of Cost Containment Strategies:
PharmacoEconomics Supplement, 6(Sup-plement 1), Adis International, 41
Centurian Drive, Private Bag 65901, Marranga Bay, Auckld 10, New
Zealand, 1994

Skinner, Brett J., Generic Drugopoly: Why Non-Patented Prescription
Drugs Cost More in Canada Than in the United States or Europe, Policy
Sources No. 82, Fraser Instiute, Vancouver, 2005

Sobell, Russell S. (Winter 2002), "Public Health and the Placebo: The
Legacy of the 1906 Pure Food and Drugs Act", Cato Journal, 21(3), pp.
463-479; at: http://www.cato.org/pubs/journal/cj21n3/cj21n3-7.pdf
and also at:
http://www.independent.org/tii/WorkingPapers/placebo.html

Sowell, Thomas (23 November 2001), "Drugs and Politics", TownHall.com;
at:
http://www.townhall.com/columnists/thomassowell/ts20011123.shtml
(31 July 2002), "Bad Medicine", TownHall.com, at:
http://www.townhall.com/columnists/thomassowell/ts20020731.shtml
(28 December 2004), "Free Lunch Safety, Part 1", Jewish World Review,
at: http://www.jewishworldreview.com/cols/sowell122804.asp
(29 December 2004), "Free Lunch Safety, Part 2", Jewish World Review,
at: http://www.jewishworldreview.com/cols/sowell122904.asp

Statman, Meir, Returns on Pharmaceutical Research and the Competitive
Equi-librium, American Enterprise Institute, Washington, DC., 1982
Competition in the Pharmaceutical Industry: The Declining Profitability
of Drug Innovation, American Enterprise Institute, Washington, DC, 1983

Sussex, Jon & Marchant, Nick, eds., Risk and Return in the
Pharmaceutical Industry, Office of Health Economics, London, 2000

Symposium, Costs and Benefits of Pharmaceutical Research, Office of
Health Economics, London, July 1987 
Innovative Competition in Medicine, Office of Health Economics, London,
Dep-tember 1992
Industrial Policy and the Pharmaceutical Industry, Office of Health
Economics, London, January 1996

Tabarrok, Alex (22 May 2000), "Drug Price Controls: A 'Cure' Worse Than
the Disease", Independent Institute, Oakland, Calif., at:
http://www.independent.org/tii/news/000522Tabarrok.html
(Summer 2000), "Assessing the FDA via the Anomaly of Off-Label Drug
Prescribing", Independent Review, 5(1), pp. 25-53; at:
http://www.independent.org/tii/media/pdf/tir51_tabarrok.pdf 
(22 August 2001), "Excess FDA Caution Threatens Health", Providence
Journal (Rhode Island); reprinted at:
http://www.independent.org/tii/news/010823Tabarrok.html

Tabler, Tanya (October 2002), "Prescription Price: Does the Payer
Matter?", Fraser Forum (Fraser Institute), pp. 18-19

Teeling-Smith, George, A Question of Balance: The Benefits and Risks of
Pharmaceutical Innovation, Office of Health Economics, London, 1980
The Future for Pharmaceuticals: The Potential, the Pattern and the
Problems, Office of Health Economics, London, 1983
Costs and Benefits of Pharmaceutical Research, Office of Health
Economics, London, 1987
ed., The Pharmaceutical Industry and Society, Office of Health
Economics, London, 1972
Innovation and Competition in Medicine: A Schumpeterian Analysis of the
Pharmaceu-tical Industry and the NHS, Office of Health Economics,
London, 1992

Temin, Peter, Taking Your Medicine: Drug Regulation in the United
States, Harvard University Press, Cambridge, Mass., 1980. A good
analysis, but with poor policy proposals.

Telser, Lester G. et al (October 1975), "The Theory of Supply With
Applications to the Ethical Pharmaceutical Industry", Journal of Law and
Economics (University of Chicago), XVIII(2), pp. 449-478

Thomas, III, L. G., The Japanese Pharmaceutical Industry: The New Drug
Lag and the Failure of Industrial Policy, Edward Elgar, Cheltenham,
Gloucesteshire, 2001

Tollison, Robert D. (1996), "Institutional Alternatives for the
Regulation of Drugs and Medical Devices", Epstein, Ralph, ed.,
Advancing Medical Innovation: Health, Safety, and the Role of Government
in the 21st Century, Progress and Freedom Foundation, Washington, DC,
pp. 17-40
(January 1998), "Speeding Drug Approvals, Safely, Privately", Consumerâs
Research (New York; http://www.acsh.org)

Tracinski, Robert W. (nd, 2000?), "Don't Let Medicare Destroy the Drug
Industry", MediaLink, The Ayn Rand Institute, Marina Del Rey, Calif.,
at: http://aynrand.org/medialink/drug-industry.shtml
(27 August 2001), "Brazil's War on Profits and Lives", Ayn Rand
Institute, at:
http://www.aynrand.org/site/News2?JServSessionIdr008=94cm4szq31.app14b&p
age=NewsArticle&id=7379&news_iv_ctrl=1073


Troy, Daniel E. (23 July 1999), "FDA Censorship Could Cost Lives", On
the Issues (American Enterprise Institute); at:
http://www.aei.org/publications/pubID.10610,filter./pub_detail.asp

Tufts Center for the Study of Drug Development, The, Research
Bibliography, at: 
http://csdd.tufts.edu/InfoServices/PublicationsResults.asp
Currently contains more than 400 articles authored by research
professionals associated with the Centre. 
Backgrounder: A Methodology for Countng Costs for Pharmaceutical R&D,
Tufts Center for the Study of Drug Development, Tufts University,
Boston, 2001; at:
http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=5

Vernon, John A. (Winter 2002-2003), "Drug Research and Price Controls",
Regulation (Cato Institute), 25(4), pp. 22-25; at:
http://www.cato.org/pubs/regulation/regv25n4/v25n4-7.pdf

Viscusi, W. Kip. (1996),  "Regulatory Reform and Liability for
Pharmaceuticals and Medical Devices," Epstein, Ralph, ed.,  Advancing
Medical Innovation: Health, Safety, and the Role of Government in the
21st Century, Progress and Freedom Foundation, Washington, DC, pp.
79-102.

Ward, Michael R. (Fall 1992), "Drug Approval Overregulation", Regulation
(Cato Institute), 15(4), pp. 47-53

Wardell, William (1973), "Introduction of New Therapeutic Drugs in the
United States and Grest Britain: An Institutional Comparison", Clinical
Pharmacology and Therapeutics, 14(5), pp. 773-779
(January 1974), "Therapeutic Implications of the Drug Lag", Clinical
Pharmacology and Therapeutics, pp. 73-96 
(1978), "The Drug Lag Revisited: Comparisons by Therapeutic Area of
Patterns of Drugs Marketed in the U.S. and Great Britain from 1972
through 1976",  Clinical Pharmacology and Therapeutics,  24,  pp.
499â524
(September/October 1979), "More Regulation or Better Therapies?",
Regulation (Cato Insti-tute), 3(5), pp. 25-33
ed., Controlling the Use of Therapeutic Drugs: An International
Comparison, Studies In Health Policy, Studies 178, American Enterprise
Institute, Washington, DC, 1978
& Lasagna, Louis, Regulation and Drug Development, Evaluative Studies
21, American Enterprise Institute, Washington, DC, 1975

Wasley, Terree, The Impact of Price Regulation on the Pharmaceutical
Industry, Competi-tive Enterprise Institute, Washington, DC, March 1993

Weidenbaum, Murray (Summer 1993), "Are Drug Prices Too High?",  The
Public Interest (New York), pp. 84â89
Restraining Medicine Prices: Controls vs. Competition, Centre for the
Study of American Business, St. Louis, 1993

Weimer, David Leo (1982), "Safe - and Available - Drugs", in Poole, Jr.,
Robert W., Instead of Regulation: Alternatives to Federal Regulatory
Agencies, Lexington Books, D. C. Heath, Lexington, Mass., pp. 239-83

Weiner, Murray (1980), "Should the Public Have the Legal Right to Use
Unproven Remedies: Yes", Lasagna, Louis, ed., Controversies in
Therapeutics, W. B. Saunders, Philadelphia

Wells, Nicholas, Pharmaceutical Innovation: Recent Trends, Future
Prospects, Office of Health Economics, London,  1983
Innovative Chemical Extensions: The Economic Basis of Pharmaceutical
Progress, Office of Health Economics, London, 1992

Young, Peter, European Pharmaceutical Policies, Adam Smith Institute,
London, 1990. On the threat of EU licensing regulations to the British
pharmaceutical industry.
 

ENDS

Dr. Chris R. Tame, Director
The Libertarian Alliance
Suite 35
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"The secret of Happiness is Freedom, and the secret of Freedom is Courage".
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