REFERENCE LIST
Abrams, J. (2003). Congress allows FDA to require tests for drugs for children. San Francisco Chronicle. Retrieved January 28, 2004, from http://www.sfgate.com/ cgi-bin/article.cgi?file=/news/archive/2003/11/19/national1643EST0737.DTL
Adams, G. B., & Balfour, D. L. (1998). Unmasking administrative evil. Thousand Oaks, CA: Sage.
Agovino, T. (2003). Regulators, Industry try to halt the tide of Canadian drugs while states, Americans seek them. Associated Press, October 13.
AP. (2003a). Canada to U.S.: Don't buy drugs here. CNN. Retrieved January 14, 2004, from http://www.cnn.com/2003/HEALTH/11/13/prescription.drugs.ap
AP. (2003b). FDA scrambles to stop Canadian drug imports. CNN. Retrieved December 17, 2003, from http://www.cnn.com/2003/HEALTH/12/17/canada.drugs.ap
Arno, P. S., Bonuck, K., & Davis, M. (1995). Rare diseases, drug development, and AIDS: The impact of the orphan drug act. Milbank Quarterly, 73(2), 231-52.
ASPA. (2004). American Society for Public Administration Code of Ethics. Retrieved September 3, 2004, from http://www.aspanet.org/scriptcontent/index_codeof ethics.cfm
Barnes, M., & Florencio, P. (2002). Financial conflicts of interest in human subjects research: The problem of institutional conflicts. Journal of Law, 30(3), 390.
Barrett, T. (2004). Pelosi rips GOP lawmaker on job offer. CNN.com. Retrieved February 24, 2004, from http://www.cnn.com/2004/ALLPOLITICS/ 01/28/tauzin.pelosi/
Bernstein, M. (1955). Regulating business through independent commission. Princeton, NJ: Princeton University Press.
Burke, J. P. (1986). Bureaucratic responsibility. Baltimore: Johns Hopkins University Press.
Burnham, D. (2001). Rene Descartes. The Internet Encyclopedia of Philosophy. Retrieved December 15, 2003, from http://www.utm.edu/research/iep/ d/descarte.htm
Cannon, M. (1997). FDA user fees have done nothing for patients. Citizens for a Sound Economy. Retrieved December 18, 2004, from http://www.cse.org/processor/ printer.php?issue_id=143
Cauchon, D. (2000). FDA advisors tied to industry. USA Today. Retrieved August 27, 2004, from http://www.dontevergiveup.com/usa_2000.htm
Chopra, S. (2003). Industry funding of clinical trials: Benefit or bias? Medical Student Journal of the American Medical Association, 290, 113.
Civil service. (2000). The Columbia encyclopedia (6th ed.) New York: Columbia University Press.
Cohen, J. (2001). Overdose: The case against the drug companies. East Rutherford, NJ: Penguin/Putnam.
Critser, G. (1997). Pill pushers: Pharmaceutical companies are emphasizing marketing and downplaying responsible medicine. Washington Monthly, 29(4), 12.
Davis, M. (2001). Conflict of interest in the professions. New York: Oxford University Press.
Davis, M. (2005), Merck mess
shows FDA’s flaws. TheStreet.com. Retrieved January 12, 2004, from
http://www.thestreet.com/stocks/melissadavid/10201457.html
DeFalco, J. (1996). The FDA vs. reform. Competitive Enterprise Institute. Retrieved February 10, 2004, from http://cei.org/gencon/025,01454.cfm
Dembner, A. (1998, April 5). Public handouts enrich drug makers, scientists. The Boston Globe, p. A5.
Deoul, K., & Silverglade, B. (2002). Symposium. Insight on the News, 18(29), 40.
Elias, P. (2004). Upbeat biotech struts in to investor conference in S.F. USA Today Retrieved January 15, 2004, from http://www.usatoday.com/tech/techinvestor/ 2004-01-12-biotech-conference_x.htm
Faloon, W. (2002, October). The FDA vs. the American consumer. Life Extension Magazine. Retrieved November 11, 2004, from http://www.lef.org/magazine/ mag2002/oct2002_awsi_01.html
Families USA. (2001). Consumer groups criticize Newsweek for transgressing ethical bounds by working with the pharmaceutical drug lobby. Families USA. Retrieved February 1, 2004, from http://www.familiesusa.org/site/PageServer?pagename= media_press_2001_newsweek
Families USA. (2002a). Fortune 500: Drug industry most profitable again. Retrieved December 17, 2003, from http://www.familiesusa.org/site/DocServer/ Fortune500Ranking.pdf?docID=319
Families USA. (2002b) Games the RX drug industry plays. Families USA Health Action Newsletter. Retrieved December 20, 2003, from http://www.familiesusa.org/site/ DocServer/Newsletter.pdf?docID=801
FDA/CDER. (1999). NDAs approved in calendar years 1990-1999. Food and Drug Administration/Center for Drug Evaluation and Research. Retrieved December 10, 2003, from http://www.fda.gov/cder/rdmt/
FDA/CDER. (2000). 2000 Report to the nation improving public health through human drugs. Center for Drug Evaluation and Research. Retrieved September 15, 2004, from http://www.fda.gov/cder/reports/rtn/2000/GRAPHICS/REPORT 2000/img0241g.jpg
FDA/CDER. (2001). 2001 Report to the nation improving public health through human drugs. Center for Drug Evaluation and Research. Retrieved September 15, 2004, from http://www.fda.gov/cder/reports/rtn/2001/rtn2001.pdf
Food and Drug Administration. (2001). The pediatric exclusivity provision. Status Report to Congress, January 2001. Retrieved January 5, 2004, from http://www.fda.gov/ cder/pediatric/reportcong01.pdf
Food and Drug Administration. (2002). FY 2000 performance report to Congress. Retrieved June 14, 2004, from http://www.fda.gov/ope/pdufa/report2000
Food and Drug Administration. (2003a). Modern FDA. Retrieved December 10, 2003, from the FDA website, http://www.fda.gov/opacom/faqs/faqs.html
Food and Drug Administration. (2003b). PDUFA III. Retrieved December 10, 2003, from the FDA website http://www.fda.gov/oc/pdufa3/2003plan/
Food and Drug Administration. (2004). FDA mission statement. Retrieved December 15, 2004. http://www.fda. gov/opacom/morechoices/mission.html
Foster, R. S. (2003). Conflicts of interest: recognition, disclosure, and management; Journal of the American College of Surgeons, 196(4).
General Accounting Office. (2002). Effect of user fees on drug approvals times, withdrawals and other agency activities. Report to the Chairman, Committee on Health, Education, Labor and Pensions, U.S. Senate. (GAO-02-958.) Retrieved November 4, 2004, from http://www.gao.gov/new.items/d02958.pdf
Geri, L. (1996, February 7). FDA drug industry user fees, pros and cons. The Progress and Freedom Foundation, 79-102.
Gerth, J., & Stolberg, S. G. (2000, April 23). Medicine merchants: Drug companies profit from research supported by taxpayers. The New York Times. Retrieved January 4, 2004, from http://www.nytimes.com/library/national/science/health/ pharmaceuticals-health.html.
Gillette, C., & Hopkins, T. (1987). Federal user fees: A legal and economic analysis. Boston University Law Review, 67(5), 795-874.
Golodner, L. (1998). Assuring the safe use of medications. National Consumer League. Retrieved February 4, 2004, from http://www.nclnet.org/ohio.htm
Grabowski, H. G., & Vernon, J. M. (1986). Longer patents for lower imitation barriers: the 1984 drug act. American Economic Review, 76, 113.
Greider, K. (2003). The big fix: How the pharmaceutical industry rips off American consumers. Public Affairs, p. 189.
Harris, G. (2004). Risks found with another painkiller. New York Times. Retrieved April 18, 2004, from http://www.jsonline.com/alive/news/dec04/2855191.asp
Harris, S. B. (1992). The right lesson to learn from Thalidomide. Retrieved February 4, 2004, from http://w3.aces.uiuc.edu:8001/Liberty/Tales/Thalidomide.html.
HCFA. (2001). National Health Expenditure Projections 2000-2010. Health Care Financing Administration, Office of the Actuary, Table 2, March 2001. Retrieved December 10, 2003, from http://www.hcfa.gov/stats
HCINJ. (2003). History of pharmaceuticals. Health Care Institute of New Jersey Retrieved December 16, 2003, from http://66.241.196.22/history.cfm
Hickman, M. (2003). The Food and Drug Administration. Hauppage, NY: Nova Science.
Higgs, R. (1995). FDA regulation of medical devices. In Hazardous to our health? FDA regulation of health care products, 55-95. Oakland, CA: The Independent Institute.
Hilts, P. (2003). Protecting America's health, the FDA, business and one hundred years of regulation. New York: Random House.
Hirshman, A.O. (1997). The passions and the interests: Political arguments for capitalism for its triumph. Princeton , NJ: Princeton University Press,
Hollon, T. (2002). Consumer coalition denounces user fee drug law renewal. Drug Topics Archive. Retrieved December 21, 2003, from http://www.drugtopics.com
Hopkins, T. (1988); Federal user fees: A legal and economic analysis. St. Louis, MI: Center for Study of American Business.
Humboldt University Economics Department. (2004). The political economy of environmental regulation and resource management. Retrieved October 16, 2004, from http://www.humboldt.edu/`envecon/ppt/423/unit6/index.htm
Hunt, M. (2000). Prescription drugs and intellectual property protection. NIHCM Issue Brief. Retrieved January 2, 2004, from http://www.nihcm.org/prescription. pdf
Johns, M., Barnes, M., & Florencio, P. (2003). Restoring balance to industry-academia relationships in an era of institutional financial conflicts of interest. Journal of the American Medical Association, 289, 741.
Kalb, P., & Koehler, K. (2002). Legal issues in scientific research. Journal of the American Medical Association, 287(1), 85.
Kaufman, M. (2002, May 23). Bill to boost industry fees that fund FDA. Washington Post, p. A01.
Kaufman, M. (2004), Many FDA scientists had drug concerns: 2002 survey shows. Washington Post, p. A01. Retrieved December 30, 2004, from http://www.washingtonpost.com/wp-dyn/articles/A3135-2004Dec15.html
Kaveny, M. C. (2000). Appropriation of evil: Cooperation's mirror image. Theological Studies, 61(2), 280.
Kelly, R. M. (1998). Representative bureaucracies and the new public management. Public Administrative Review, 58(3), 201.
Kettl, D. F. (2000). Public administration at the millennium: The state of the field. Journal of Public Administration Research and Theory, 10(1), 7.
Khushf, G., & Gifford, R. (1998). Understanding, assessing and managing conflicts of interest. New York: Oxford University Press.
Krauss, M. I. (1996, Spring). Loosening the FDA's drug certification monopoly: Implications for tort law and consumer welfare. George Mason Law Review 4, 457-83.
Kurian, T. (1998). A historical guide to the U.S. government. New York: Oxford University Publishers.
Lamb, G. (2005). Drug tests: too speedy - or safe enough? The Christian Science Monitor. Retrieved January 15, 2005, from http://www.csmonitor.com/2005/ 0106/p14s01-ussc.html
Leary, T. B. (2000). Antitrust issues in settlement of pharmaceutical patent disputes. Federal Trade Commission, Retrieved January 15, 2004, from http://www.ftc. gov/speeches/leary/learypharma.htm
LeBlanc, S., & Sabados, R. (1996, July 11). Oxandrolone Background. Bay Area Reporter, p. B-5.
Levitt, L. (2002). Prescription drug trends. Kaiser Foundation and Sonderegger Research Center, University of Wisconsin. Retrieved September 20, 2004, from http://www.kff.org/rxdrugs/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=13709
Lurie, P. (2002). GAO Report backs link between drug user fees and higher rate of drug withdrawals. Public Citizen. Retrieved December 15, 2003, from http://www. citizen.org/pressroom/print_release.cfm?ID=1224
Lurie, P., &Wolf, R. (1998). FDA medical officers report lower standards permit dangerous drug approvals. Public Citizen. Retrieved December 15, 2003, from http://www.citizen.org/publications/release.cfm?ID=7104
Mace, G. (1979). Locke, Hobbes, and the federalist papers: An essay on the genesis of the American political heritage. Carbondale, IL: Southern Illinois University Press.
Mahan, D. (2002). Profiting from pain: Where prescription drug dollars go? Families USA. Retrieved January 3, 2004, from http://www.familiesusa.org/site/ DocServer/PPreport.pdf?docID=249
Miller, H. I. (1998). Failed FDA reform. Regulation, 21(3), 24–30.
Miller, H. I. (2000). To America's health: A proposal to reform the Food and Drug Administration. Vol. 50. Stanford, CA: Hoover Institution Press.
Mitka, M. (2003, February 19). Survey suggesting that prescription drug ads help public is met with skepticism. Journal of the American Medical Association, 289 (7), 27.
Moore, T., Psaty, B., & Furberg, C. (2002). Time to act on drug safety. Journal of the American Medical Association, 279(19), 1571.
NIHCM. (2000). Prescription drugs and intellectual property protection, National Institute for Health Care Management. Retrieved February 1, 2004, from http://www.nihcm.org/prescription.pdf
NIHCM. (2002, April). Prescription drug expenditures in 2001: Another year of escalating costs. National Institute for Health Care Management. Retrieved February 1, 2004, from http://www.nihcm.org/spending2001.pdf
Osborne, D., & Gaebler, T. (1992). Reinventing government: How the entrepreneurial spirit is transforming the public sector. New York: Addison-Wesley.
Ostrom, V. (1989). Intellectual crisis in American public administration. Tuscaloosa, AL: University of Alabama Press.
Peterson, J. (2005, January). FDA approach tough pill for critics. Houston Chronicle. Retrieved January 8, 2005, from http://www.HoustonChronicle.com
PhRMA. (2002-2003). Pharmaceutical research and manufacturers of America 2002 industry profile. PhRMA Annual Report 2002-2003. Retrieved January 15, 2004, from http://www.phrma.org/publications/publications/profile02/index.cfm
Pomper, S. (2000). Drug rush. Washington Monthly, 32(5), 31.
Public Citizen. (2000, June 20). Citizens for better Medicare: The truth behind the drug industry's deception of America's seniors. Retrieved January 15, 2004, from http://www.citizen.org/pressroom/release.cfm?ID=269
Public Citizen. (2001). The other drug war: Big Pharma's 625 Washington Lobbyists. Retrieved January 5, 2004, from http://www.citizen.org/publications/release.cfm? ID=7077
Public Citizen. (2002a). Brand-name companies vs. generics: Lobbying and campaign contributions. Retrieved January 5, 2004, from http://www.citizen.org/congress/ reform/drug_industry/contribution/articles.cfm?ID=8045
Public Citizen. (2002b). Briefing book on the Rx drug debate. Public Citizen. Retrieved January 5, 2004, from http://www.citizen.org/rxfacts
Public Citizen. (2002c). The other drug war II: Drug companies use an army of 623 lobbyists to keep profits up. Retrieved January 5, 2004, from http://www.citizen.org/congress/reform/drug_industry/contribution/articles.cfm?ID=7908
Public Citizen. (2002d). Public Citizen decries conflict of interest created by new law regulating safety of medical devices. Retrieved January 5, 2004, from http://www.citizen.org/pressroom/release.cfm?ID=1244
Public Citizen. (2002e). United Seniors Association: Hired guns for PhRMA and other corporate interests. Retrieved January 5, 2004, from http://www.citizen.org/ congress/campaign/special_interest/articles.cfm?ID=7999
Public Citizen. (2003a). FDA should consider lengthening drug approval times, Inspector General's report says. Public Citizen. Retrieved January 5, 2004, from http://www.citizen.org/pressroom/release.cfm?ID=1378
Public Citizen. (2003b). Unprecedented number of drug withdrawals point to problems in fda drug approval process. Retrieved February 14, 2004, from http://www.citizen.org/print_article.cfm?ID=7442
Pugh, T., & Borenstein, S. (2004). American consumers suffering as more new drugs debut in US, analysis shows. Knight-Ridder. Retrieved December 22, 2004, from http://www.healthyskepticism.org/library/ref.php?id=268
Rahkonen, D. (2003). In sickness and in wealth: America's healthcare failure. Online Journal. Retrieved February 2, 2004, from http://www.onlinejournal.com/ Commentary/120103Rahkonen/120103rahkonen.html
Rehnquist, J. (2003). FDA should consider lengthening drug approval times, Inspector General's Report says. Public Citizen. Retrieved December 21, 2003, from http://www.citizen.org/pressroom/print_release.cfm?ID=1378
Riper, P. P. Van. (1997). Some anomalies in the deep history of the U.S. Public Administration. Public Administration Review, 57(3), 218.
Romano, M. (1995). Federal criminal conflict of interest. American Criminal Law Review, 32(2), 347-377.
Sasich, L. (2000). Comments on the Prescription Drug User Fee Act (PDUFA). Retrieved December 15, 2003, from http://www.citizen.org/publications/release. cfm?ID=6737
Sasich, L., & Wolfe, S. (2002). Comments on the Prescription Drug User Fee Act (PDUFA). Retrieved December 15, 2003, from http://www.citizen.org.
Schondelmeyer, S. W. (2002). Competition and pricing issues in the pharmaceutical market. PRIME Institute, University of Minnesota, based on data found in Fortune magazine, 1958 to 1999; Fortune Magazine, April 17, 2003. Retrieved February 1, 2004, from http://www.affordablerx.org/media/Media15.htm
Sharav, V. (2004). Lawmaker calls for FDA review amid drug safety troubles. Retrieved April 18, 2004, from http://www.ahrp.org/infomail/04/12/19.php
Shaw, J. (2004). Public choice theory: The concise encyclopedia of economics. Retrieved November 22, 2004, from http://www.econlib.org/library/Enc/PublicChoice Theory.html
Sherman, M. (2004, June 17). Congress finds few problems at Canadian Net pharmacies; USAToday.com.
Sigelman, D. (2002). Dangerous medicine: So what if the speedup at the FDA is putting poisons on pharmacy shelves? Congress doesn't want to know. The American Prospect, 13(17), 30.
Smith, A. (1777). An inquiry into the nature and causes of the wealth of nations. Oxford: Clarendon Press, 1976.
Strand, R. (2003). Death by prescription. Nashville, TN: Thomas Nelson.
Tansey, B. (2003). Citizens use law to pursue drug firms citing unfair competition and weak FDA oversight, consumer coalition sues giant pharmaceutical companies. San Francisco Chronicle. Retrieved January 4, 2004, from http://www.sfgate. com/cgi-bin/article.cgi?file=/chronicle/archive/2003/11/23/BUG5D37C851.DTL
Tanouye, E. (1998, November 16). Drug dependency: U.S. has developed an expensive
U.S. Congressional Budget Office. (1983). An analysis of the president's budgetary proposals for fiscal 1984. Retrieved December 15, 20004, from http://www.cbo.gov/showdoc.cfm?index=5058&seqyence=0
U.S. Congressional Budget Office. (1998). How increased competition from generic drugs has affected prices and returns in the pharmaceutical industry. Retrieved June 5, 2004, from http://www.cbo.gov/showdoc.cfm?index=655&sequence=0
U.S. General Accounting Office. (1980). FDA drug approvals—a lengthy process. Retrieved November 10, 2004, from http://archive.gao.gov/d46t13/1112450.pdf
Volokh, A. (1995 December/January). Leaving us to our own devices. The Journal for Respiratory Care Practitioners. Retrieved January 5, 2004, from http://kuznets.fas.harvard.edu/~volokh/rt.html
Wamsley, G. L., Bacher, R. N., Goodsell, C. T., Kronenberg, P. S., Rohr, J. A., Stivers, C., White, O. F., & Wolf, J F. (1990). Refounding public administration. Newbury Park, CA: Sage.
Washburn, J. (2001). Undue influence. The American Prospect, 1, 16.
Waters, R. (2004). Lawmakers open probe of FDA. Agency accused of barring safety data on antidepressants. San Francisco Chronicle. Retrieved May 16, 2004, from http://www.sfgate.com/cgo-bin/article.cgi?file=/chronicle/archive/2004/03/31/ MNGRT5U12C1.DTL
Waxler, M., & Gross, G. (2003). FDA user fees: Do faster review times justify the financial burden? Wisconsin Technology Network Retrieved February 3, 2004, from http://www.wistechnology.com/article.php?id=478
Welch, W. (2003, October 7). Once just a trickle, Canada's RX drugs pouring into USA. USA Today. Retrieved January 4, 2004, from http://www.usatoday.com/ news/nation/2003-10-06-canada-drugs-usat_x.htm
Willis, M. (2003). Risk of the new. Research suggests greater risks accompany newly approved drugs. ABCnews.com Retrieved January 20, 2004, from http://more.abcnews.go.com/sections/living/dailynews/new_drug_safety020501.html
Willman, D. (2000, December 20). How a new policy led to seven deadly drugs. Los Angeles Times, p. A1.
Woosley, R. (1994). A prescription for better prescriptions. Issues in Science and Technology, 10(3), p. 59.
Zimmerman, M. (2001, February 5). Drug makers find a windfall testing adult drugs on kids. The Wall Street Journal, 19(2), p. A2.