A Model of Effective Health Policy: The 1983 Orphan Drug Act

Journal of Health and Social Policy

Volumn 17, Issue 4, 2003, Pages 61-71

  Reaves, Natalie D ^a  

^a ROWAN UNIVERSITY   (United States)

Author keywords

Health policy; Orphan drugs; Pharmaceutical industry; Regulation

Indexed keywords

ORPHAN DRUG;

HEALTH POLICY;

DRUG APPROVAL; DRUG INDUSTRY; DRUG RESEARCH; GOVERNMENT REGULATION; HEALTH CARE POLICY; RARE DISEASE; REVIEW;

HEALTH POLICY; ORPHAN DRUG PRODUCTION; UNITED STATES;

EID: 1142286464     PISSN: 08977186     EISSN: None     Source Type: Journal    
DOI: 10.1300/J045v17n04_04     Document Type: Review

References (25)

1. Alan Guttmacher Institute (AGI). "Are Women Achieving Their Childbearing Goals?" Issues in Brief. New York. 1996.
2. Alan Guttmacher Institute (AGI). "Abortion in Context: United States and Worldwide." Issues in Brief. New York. 1999.
3. Boston Consulting Group. "Sustaining Innovation in U.S. Pharmaceuticals." 1996.
4. Chandra, A. "Surgical Sterilization In The United States: Prevalence and Characteristics, 1965-95," National Center for Health Statistics. 1998. Vital Health Statistics 23(2).
5. DiMasi, J.A. "Trends In Drug Development Costs, Times, and Risks." Drug Information Journal 29, 1995. 375-384.
6. DiMasi, J.A. Hansen, R.W., Grabowski, H.G., Lasagna, L. "Research and Development Costs For New Drugs by Therapeutic Category." Pharmacoeconomics 7(2), 1995. 152-169.
7. DiMasi, J.A. Hansen R.W., Grabowski, H.G., and Lasagna, L. "Cost of Innovation in the Pharmaceutical Industry." Journal of Health Economics 10(1), 1991. 107-142.
8. Food and Drug Administration (FDA), Office of Orphan Product Development. "List of Orphan Product Designations and Approvals Through December 2001." 2002. Rockville, MD.
9. Forrest, J.D., Samara, R. "Impact of Publicly Funded Contraceptive Services on Unintended Pregnancies and Implication For Medicaid Expenditures." Family Planning Perspectives 1996. 28 188-195.
10. Gallup, J.L. and Sachs, J.D. "The Economics Burden of Malaria. " CID Working Paper No. 52 July 2000. Harvard University.
11. Global Forum For Health Research 2000. "The 10/90 Report on Health Research 2000." World Health Organization. Geneva. April 2000.
12. Grabowski, H.G., Vernon, J.M., Thomas, L.G. Estimating The Effects of Regulation on Innovation: An International Comparative Analysis of The Pharmaceutical Industry. The Journal of Law and Economics 21(1), 1978. 133-163.
13. Harrison, P.F., Rosenfield, A. Eds. Contraceptive Research and Development: Looking Into the Future. Washington: National Academy Press. 1996.
14. Henkel, J. "Orphan Drug Law Matures into Medical Mainstay." 1999. FDA Consumer 33, 29-33.
15. Henshaw, S.K. "Unintended Pregnancy in the United States." Family Planning Perspectives 1998. 30: 24-29, 46.
16. Heymann, D.L. The Urgency of a Massive Effort Against Infectious Diseases." Executive Director for Communicable Diseases for WHO: Before the Committee On International Relations: U.S. House of Representatives, June 29, 2000.
17. Jensen, E.J. "Research Expenditures And The Discovery Of New Drugs." The Journal of Industrial Economics 36(1), 1987. 83-95.
18. Kassalow, J.S. "Why Health Is Important to U.S. Foreign Policy." May 2001. Council on Foreign Relations/Milbank Memorial Fund, New York, NY.
19. National Intelligence Council 2000. "The Global Infectious Disease Threat and Its Implications for the United States." National Intelligence Estimate 99-17D. Washington, DC.
20. Pecoul, B., Chirac, P., Trouiller, P., Pinel J., "Access to Essential Drugs In Poor Countries: A Lost Battle" JAMA Vol. 281 No. 4 Jan 1999. pp. 361-367.
21. Phrma, Pharmaceutical and Research Manufacturers of America, "2001 Industry Profile." Washington: 2001.
22. Reaves, N.D. "Pharmaceutical Innovation and Orphan Drugs." Pennsylvania Economic Review. 10(2) Fall 2001. pp. 29-38.
23. Shulman, S.R., Manocchia, M. "The U.S. Orphan Drug Programme: 1983-1995." Pharmacoeconomics 12(3), 1997. 312-326.
24. Thomas, L.G "Regulation and Firm Size: FDA Impacts on Innovation." Rand Journal of Economics 21(4), 1990. 497-517.
25. World Health Organization. "The World Health Report 2001." Geneva. WHO 2001.