The patents-Based pharmaceutical development process rationale, problems, and potential reforms

JAMA

Volumn 294, Issue 16, 2005, Pages 2075-2082

  Barton, John H ^a,b   Emanuel, Ezekiel J ^a,c  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b STANFORD LAW SCHOOL   (United States)

^c NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; ORPHAN DRUG;

ADVERTIZING; ARTICLE; DEVELOPED COUNTRY; DEVELOPING COUNTRY; DRUG APPROVAL; DRUG COST; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; FINANCIAL MANAGEMENT; FOOD AND DRUG ADMINISTRATION; HEALTH CARE COST; PATENT; PRIORITY JOURNAL; PROFIT; ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH; DRUG LEGISLATION; ECONOMICS; ETHICS; HEALTH CARE AND PUBLIC HEALTH; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; POLICY; UNITED STATES;

ANALYTICAL APPROACH; BIOMEDICAL AND BEHAVIORAL RESEARCH; HEALTH CARE AND PUBLIC HEALTH;

DEVELOPING COUNTRIES; DRUG APPROVAL; DRUG COSTS; DRUG INDUSTRY; LEGISLATION, DRUG; ORGANIZATIONAL POLICY; PATENTS; PUBLIC SECTOR; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 27244448824     PISSN: 00987484     EISSN: 15383598     Source Type: Journal    
DOI: 10.1001/jama.294.16.2075     Document Type: Article

References (48)

1. Angell M. The Truth About the Drug Companies - How They Deceive Us and What to Do About It. New York, NY: Random House; 2004.
2. Médécins Sans Frontières. MSF Puts Drug Patents Under the Spotlight. May 22, 2003. Available at: http://www.accessmed-msf.org/ prod/publications.asp ?scntid=2252003114784&contenttype=PARA&. Accessibility verified September 9, 2005.
3. Greider K. The Big Fix: How the Pharmaceutical Industry Rips Off American Consumers. Cambridge, Mass: PublicAffairs; 2003.
4. Scherer FM. The pharmaceutical industry - prices and progress. N Engl J Med. 2004;351:927-932.
5. Kaiser Family Foundation. Prescription Drug Trends. May 2003. Available at: http://www.kff.org. Accessibility verified September 9, 2005.
6. Centers for Medicare & Medicaid Services. National Health Expenditures. Available at: http://www .cms.hhs.gov/review/supp/. Accessibility verified September 9, 2005.
7. Cutler DM, McClellan M. Is technological change in medicine worth it? Health Aff (Millwood). 2001;20:11-29.
8. Lichtenberg FR. Availability of new drugs and Americans' ability to work. J Occup Environ Med. 2005;47:373-380.
9. Pharmaceutical Research and Manufacturers of America. Pharmaceutical Industry Profile 2005. Available at: http://www.phrma.org. Accessibility verified September 9, 2005.
10. Barton JH. TRIPS and the global pharmaceutical market. Health Aff (Millwood). 2004;23:146-154.
11. Penrose ET. The Economics of the International Patent System. Baltimore, Md: Johns Hopkins University Press; 1951.
12. Constitution of the United States. Article 1, §8. Available at: http://www.constitutioncenter.org/explore/TheU.S.Constitution/index/html. Accessibility verified September 26, 2005.
13. 35 USC §§101, 102, 103, 112.
14. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151-186.
15. US Office of Technology Assessment. Pharmacutical R&D: Costs, Risks, and Rewards. February 1993. Publication OTA H-522. Available at: http://www.wws.princeton.edu/~ota/ns20/pubs_f.html. Accessibility verified September 9, 2005.
16. Shulman SR, DiMasi JA, Kaitin KI. Patent term restoration: the impact of the Waxman-Hatch Act on new drugs and biologics approved 1984-1995. J Biolaw Bus. 1999;2:63-68.
17. National Institute for Health Care Management. Issue Brief: Prescription Drugs and Intellectual Property Protection. August 2000. Available at: http://www.nihcm.org/prescription.pdf. Accessibility verified September 9, 2005.
18. Villarreal MA. Orphan Drug Act: background and proposed legislation in the 107th Congress: Congressional Research Service Report for Congress. July 25, 2001. Available at: http://www.law.umaryland.edu/marshall/crsreports/ crsdocuments/RS20971.pdf. Accessibility verified September 14, 2005.
19. USFoodandDrugAdministration.TheOrphanDrug Act. 1983. Available at: http://www.fda.gov/orphan /oda.htm. Accessibility verified September 26, 2005.
20. US Food and Drug Administration. Federal Food, Drug, and Cosmetic Act. 2004. Available at: http://www.fda.gov/opacom/law/fdcact/fdctoc.htm. Accessibility verified September 26, 2005.
21. US Food and Drug Administration. Scientific considerations related to developing follow-on protein products, 69 Federal Register 50386 (2004).
22. Tufts Center for the Study of Drug Development. Outlook 2003. Available at: http://www.csdd.tufts.edu. Accessibility verified September 9, 2005.
23. US Food and Drug Administration. Challenge and Opportunity on the Critical Path to New Medical Products. Washington, DC: US Food and Drug Administration; 2004.
24. Tufts Center for the Study of Drug Development. Outlook 2004. Available at: http://www.csdd.tufts.edu. Accessibility verified September 9, 2005.
25. Pammolli F, Riccaboni M. Market structure and drug innovation. Health Aff (Millwood). 2004;23:48-50.
26. Friedman MA, Woodcock J, LumpkinMM,Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA. 1999;281:1728-1734.
27. Cockburn IM. The changing structure of the pharmaceutical industry. Health Aff (Millwood). 2004;23:10-22.
28. Project BioShield Act of 2004, Pub L No. 108-276.
29. Pharmaceutical Research and Manufacturers of America. Pharmaceutical Industry Profile 2002. Washington, DC: PhRMA; 2002.
30. Kaiser Family Foundation. Prescription Drug Trends. November 2001. Available at: http://www.kff.org. Accessibility verified September 9, 2005.
31. PriceWaterhouseCoopers. The Value of Pharmacy Benefit Management and the National Cost Impact of Proposed PBM Legislation. 2004. Available at: http://www.pwchealth.com/cgi-local/hcregister.cgi?link=pdf/savings.pdf. Accessibility verified September 9, 2005.
32. Calfee J. International Pharmaceutical Pricing: Price Controls Discourage Innovation: Testimony to Senate Committee on Finance, Joint Committee on International Trade and Health. April 27, 2004. Available at: http://www.aei.org/publications/filter.all,pubID.20476/pub_detail.asp. Accessibility verified September 9, 2005.
33. Pub L No. 108-173, §101, 42 USC §1869D-11(i) (2003).
34. HHS Task Force on Drug Importation. Report on Prescription Drug Importation. Washington, DC: US Dept of Health and Human Services; 2004.
35. Scherer FM, Watal J. Post-TRIPS options for access to patented medicines in developing nations. J Int Econ Law. 2002;5:913-939.
36. Lanjouw JO. A new global patent regime for diseases: U.S. and international legal issues. Harv J Law Technol. 2002;16:2-40.
37. Kaisernetwork.org. Daily HIV/AIDS Report: Reduced-Cost Antiretroviral Drugs Meant for Distribution in African Nations Sold on Black Market in Europe. January 2, 2003. Available at: http://Kaisernetwork.org. Accessibility verified September 9, 2005.
38. Kremer M. Patent Buy-outs: A Mechanism for Encouraging Innovation. Cambridge, Mass: National Bureau of Economic Research; 1997. Working Paper W6304.
39. Sobel D. Longitude: The True Story of a Lone Genius Who Solved the Greatest Scientific Problem of His Time. New York, NY: Penguin Books; 1995.
40. Grabowski H. Alternatives to the patent system: perspectives from economics. Presented at: Innovation in the Life Sciences: Intellectual Property and Public Investment for Pharmaceuticals and Agriculture; May 21, 2004; New York, NY. Available at: http://www.earthinstitute.columbia.edu/cgsd/events /life_sciences_agenda.html. Accessibility verified September 9, 2005.
41. Kremer M. Creating markets for new vaccines. In: Jaffe AB, Stern S, eds. Innovation Policy and the Economy. Vol 1. Cambridge, Mass: MIT Press; 2001.
42. Barton JH. Financing of vaccines. Lancet. 2000;355:1269-1270.
43. The Fortune 500: how the industries stack up. Fortune. April 15, 2004:F26.
44. Arno PS, Bonuck K, Davis M. Rare diseases, drug development, and AIDS: the impact of the orphan drug act. Milbank Q. 1995;73:231-252.
45. Summers LH. Testimony before the Senate Appropriations Subcommittee on Foreign Operations on the Administration's FY 2001 Budget Request for Treasury's International Programs. April 6, 2000.
46. Elias P. Orphan drugs save lives, but who pays? May 23, 2003. Available at: http://www.rarediseases.org/nord/news/articles/orphandrugs_whopays. Accessibility verified September 9, 2005.
47. Whalen J. A big drug maker moves to play down mass-market pills. Wall Street Journal. September 20, 2004:A1.
48. World Health Organization. Water, Sanitation and Hygiene Links to Health. Available at: http://www.who.int/water_sanitation_hrealth/publications/ facts2004/en/index.html. Accessibility verified September 26, 2005.