Pharmaceutical policy change and the safety of new drugs

Journal of Law and Economics

Volumn 45, Issue 2 II, 2002, Pages 615-642

  Olson, Mary K ^a  

^a YALE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0042634111     PISSN: 00222186     EISSN: None     Source Type: Journal    
DOI: 10.1086/368006     Document Type: Conference Paper

References (21)

1. Aoki, Naomi. "FDA Walks Fine Line on Drug Approvals: Battle over Irritable-Bowel Medication's Risks, Benefits Illustrates Pressures Facing Regulators." Boston Globe, June 26, 2002, p. C1.
2. Bakke, O. M., et al. "Drug Safety Discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A Regulatory Perspective." Clinical Pharmacology and Therapeutics 58 (1995): 108-17.
3. Cameron, A. Colin, and Trivedi, Pravin K. Regression Analysis of Count Data. Cambridge: Cambridge University Press, 1998.
4. Friedman, Michael A., et al. "The Safety of Newly Approved Medicines: Do Recent Market Removals Mean There Is a Problem?" Journal of the American Medical Association 281 (1999): 1728-34.
5. Kaitin, Kenneth I. "The Prescription Drug User Fee Act of 1992 and the New Drug Development Process." American Journal of Therapeutics 4 (1997): 167-72.
6. Kaitin, Kenneth I., and Healy, Elaine M. "The New-Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Era." Drug Information Journal 34 (2000): 1-14.
7. Kaitin, Kenneth I., and Manocchia, M. A. "The New-Drug Approvals of 1993, 1994, and 1995: Trends in Drug Development." American Journal of Therapeutics 4 (1997): 46-54.
8. Kaitin, K. I., et al. "Therapeutic Ratings and End-of-Phase II Conferences: Initiatives to Accelerate the Availability of Important New Drugs." Journal of Clinical Pharmacology 31 (1991): 17-24.
9. Kaitin, K. I., et al. "The New-Drug Approvals of 1990, 1991, and 1992: Trends in Drug Development." Journal of Clinical Pharmacology 34 (1994): 120-27.
10. Kennedy, Peter. A Guide to Econometrics. 3d ed. Cambridge, Mass.: MIT Press, 1992.
11. Niskanen, William A. Bureaucracy and Representative Government. Chicago: Aldine-Atherton, 1971.
12. Olson, Mary K. "Regulatory Agency Discretion among Competing Industries: Inside the FDA." Journal of Law, Economics, and Organization 11 (1995): 379-405.
13. Olson, Mary K. "Substitution in Regulatory Agencies: FDA Enforcement Alternatives." Journal of Law, Economics, and Organization 12 (1996): 376-407.
14. Olson, Mary K. "Regulatory Reform and Bureaucratic Responsiveness to Firms: The Impact of User Fees in the FDA." Journal of Economics and Management Strategy 9 (2000): 363-95.
15. Peltzman, Sam. "The Health Effects of Mandatory Prescriptions." Journal of Law and Economics 30 (1987): 207-38.
16. Quirk, Paul J. "Food and Drug Administration." In The Politics of Regulation, edited by James Q. Wilson. New York: Basic Books, 1980.
17. Shulman, Sheila R., and Kaitin, Kenneth I. "The Prescription Drug User Fee Act of 1992: A 5-Year Experiment for Industry and the FDA." PharmacoEconomics 9 (1996): 121-33.
18. Tufts Center for the Study of Drug Development. "Tufts Center for the Study of Drug Development Pegs Cost of a New Prescription Medicine at $802 Million." News release. November 30, 2001. http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid = 6.
19. U.S. Congress. Office of Technology Assessment. Pharmaceutical R&D: Costs, Risks and Rewards. Washington, D.C.: Goverment Printing Office, February 1993. http://www.wws.princeton.edu/̃ota/disk1/1993/9336_n.html.
20. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. CDER 1998 Report to the Nation: Improving Public Health through Human Drugs. Rockville, Md.: Center for Drug Evaluation and Research, 1998. http://www.fda.gov/cder/reports/rptntn98.pdf.
21. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. "Priority Review Policy." In Manual of Policies and Procedures. MAPP 6020.3, 1996. http://www.fda.gov/cder/mapp/6020-3.pdf.