Viagra's rise above women's health issues: An analysis of the social and political influences on drug approvals in the United States and Japan

Social Science and Medicine

Volumn 62, Issue 3, 2006, Pages 683-693

  Hollander, Ilyssa ^a  

^a Social Sectors Development Strategies Inc   (United States)

Author keywords

Drug approval; Japan; Medical abortion; Oral contraception; Pharmaceuticals; Regulation; USA; Viagra

Indexed keywords

ESTROGEN; GESTAGEN; MIFEPRISTONE; MISOPROSTOL; ORAL CONTRACEPTIVE AGENT; SILDENAFIL;

CONTRACEPTIVE USE; GENDER DISPARITY; HEALTH AND DISEASE; PHARMACEUTICAL INDUSTRY; POLITICAL POWER; SEXUAL BEHAVIOR; SOCIAL MOVEMENT;

ABDOMINAL CRAMP; BACKACHE; BLEEDING; CLINICAL TRIAL; COLOR VISION; CONFERENCE PAPER; DIARRHEA; DIZZINESS; DRUG APPROVAL; DRUG FATALITY; DRUG SAFETY; ERECTILE DYSFUNCTION; FATIGUE; FLUSHING; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEART INFARCTION; HUMAN; INDIGESTION; JAPAN; MORALITY; NAUSEA; POLITICS; SIDE EFFECT; SOCIAL ASPECT; SOCIAL INTERACTION; STROKE; THERAPEUTIC ABORTION; UNITED STATES; URINARY TRACT INFECTION; VISUAL DISORDER; VOMITING;

ATTITUDE TO HEALTH; CONTRACEPTIVES, POSTCOITAL; DRUG APPROVAL; DRUG INDUSTRY; FEMALE; HUMANS; JAPAN; MALE; PIPERAZINES; POLITICS; PUBLIC POLICY; PURINES; SULFONES; TRUST; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WOMEN'S HEALTH;

ASIA; EURASIA; FAR EAST; JAPAN; NORTH AMERICA; UNITED STATES;

EID: 29144507701     PISSN: 02779536     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.socscimed.2005.03.046     Document Type: Conference Paper

References (70)

1. J. Abraham Science, politics and the pharmaceutical industry: Controversy and bias in drug regulation 1995 St. Martin's Press New York
2. J. Abraham The pharmaceutical industry as a political player Lancet 360 9344 2002 1498 1502
3. Asiaweek.com (1996). Just Do It: Japan should cut the excuses and legalize the pill. Asiaweek.com. Retrieved September 2002, from: http://www.asiaweek.com/asiaweek/96/0913/ed2.html.
4. M.M. Bean Fatal flaws in the food and drug administration's drug-approval formula Utah L. Review 2003 2003 881 912
5. P. Blumenthal, J. Johnson, and F. Stewart The approval of mifepristone (RU486) in the United States: What's wrong with this picture? Medscape Womens Health 5 4 2000 E7
6. 21 C.F.R. Sect. 314.500 (1999). Applications for FDA approval to market a new drug: Subpart H - accelerated approval of new drugs for serious or life-threatening conditions. 21 C.F.R. Sect. 314.500.
7. 21 C.F.R. Sect. 314.105 (2000). Applications for FDA Approval to Market a New Drug: FDA Action on Applications and Abbreviated Applications. 21 C.F.R. Sect. 314.105.
8. Congressional Record (1998). Congressional Record, H5089. Re: H. Amdt. 705 (A009) An amendment to prohibit funds to be used by the FDA for any drug for the chemical inducement of abortion. H.R. 4101. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations.
9. D.A. Copelton Assessing the Social Impact of Mifepristone in the United States: A Pro-Choice Perspective Kansas Journal of Law and Public Policy 11 2001 333 352
10. Cornell, A. (1999). Viagra proves a bitter pill for Japanese women. Australian Financial Review (Sect. International News:8).
11. Cruzan, S. (1996). FDA Advisory Committee Reviews Mifepristone. Answers. No. T96-51. Retrieved September 2002, from: http://www.fda.gov/bbs/topics/ ANSWERS/ANS00748.html.
12. Dag Hammarskjöld Foundation Health and drug policies, making them the top of the agenda: A strategy paper on the development of national drug policies The Journal of the Dag Hammarskjöld Foundation, Development Dialogue 1995 1 24
13. A. Domoto Japan: Seeds of consciousness [abstract] Plan Parent Chall 2 1993 11 13
14. J.M. Drazen, M.F. Greene, and A.J. Wood The FDA, politics, and plan B New England Journal of Medicine 350 15 2004 1561 1562
15. Effective Medicines Regulations (2003). Effective medicines regulation: ensuring safety, efficacy and quality. WHO Policy Perspectives on Medicines, No. 7.
16. Efron, S. (1999). Japan oks birth control pill after decades of delay; Asia: Female contraception took 34 years for approval, while men waited only six months for viagra to go on sale. Los Angeles Times (Sect. A: 1), June 3.
17. Farley, D. (1995). Benefit vs. risk: How FDA approves new drugs. FDA Consumer Special Report on New Drug Development in the United States. Retrieved September 2002, from: http://www.fda.gov/fdac/special/newdrug/benefits.html.
18. Food and Drug Administration (1996). Mifeprex approvable letter. NDA 20-687.
19. Food and Drug Administration (1998a). Viagra approval letter. Application No. 020895.
20. Food and Drug Administration (1998b). Pfizer updates viagra labeling. FDA talk paper, No. T98-83. Retrieved September 2002, from: http://www.fda.gov/bbs/ topics/ANSWERS/ANS00926.html.
21. Food and Drug Administration (1998c). FDA approves impotence pill, viagra. FDA talk paper, No. T98-14. Retrieved September 2002, from: http://www.fda.gov/bbs/topics/ANSWERS/ANS00857.html.
22. Food and Drug Administration (2000a). Mifeprex approvable letter. NDA 20-687.
23. Food and Drug Administration (2000b). Memorandum to: NDA 20-687 MIFEPREX (mifepristone). Population council.
24. Food and Drug Administration (2000c). Mifeprex approval letter. NDA 20-687.
25. Food and Drug Administration (2003). Birth control guide. Retrieved December 2004, from: http://www.fda.gov/fdac/features/1997/babyguide2.pdf.
26. Food and Drug Administration (N.D.a). Approval times for priority and standard NDAs calendar years 1993-2003. Retrieved June 2003, from http://www.fda.gov/cder/rdmt/NDAapps93-03.html.
27. Food and Drug Administration (N.D.b). Mifepristone medication guide. Retrieved October 2002, from: http://www.fda.gov/cder/drug/infopage/ mifepristone/medguide.htm.
28. Food and Drug Administration (N.D.c). Mifepristone questions and answers. Retrieved October 2002, from: http://www.fda.gov/cder/drug/infropage/ mifepristone/mifepristone-qa.htm.
29. Food and Drug Administration (N.D.d). Viagra consumer information. Retrieved September 2002, from: http://www.fda.gov/cder/consumerinfo/druginfo/ Viagra.htm.
30. Food and Drug Administration (N.D.e). Post marketing safety of sidenafil citrate (viagra). Retrieved October 2002, from: http://www.fda.gov/cder/ consumerinfo/viagra/safety3.htm.
31. A. Goto, C. Fujiyama-Koriyama, A. Fukao, and M.R. Reich Abortion trends in Japan, 1975-95 Studies in Family Planning 31 4 2000 301 308
32. A. Goto, M. Reich, and I. Aitken Oral contraceptives and women's health in Japan Journal of the American Medical Association 282 22 1999 2173 2177
33. IMS Health (N.D.). "The Pill" finally reaches Japan. Retrieved October 2002, from: http://www.ims-global.com//insight/news_story/ news_story_991013.htm.
34. International Conference on Harmonization (1997). Statement by the ICH Steering Committee on the occasion of the fourth international conference on harmonization. Brussels, 16-18 July 1997. Retrieved July 2004, from: http://www.ich.org/MediaServer.jser?@_ID=3488@_MODE=GLB.
35. International Conference on Harmonization (1998). ICH harmonized tripartite guideline. Ethnic factors in the acceptability of foreign clinical data. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. February 5, 1998. Retrieved May 2004, from: http://www.ich.org/MediaServer.jser?@_ID=4818@_MODE=GLB.
36. International Conference on Harmonization (N.D.). Efficacy guidelines: Status of efficacy topics. E5: Ethnic factors in the acceptability of foreign clinical data. Retrieved June 2004, from: http://www.ich.org/UrlGrpServer.jser? @_ID=475&@_FORCETEMPLATE=272.
37. Kamimura, M. (1999). Japan approves "pill" after nearly decade of debate. CNN.com. Retrieved October 2002, from: http://www.cnn.com/HEALTH/ women/9906/02/japan.pill.02/index.html.
38. D. Kennedy An epidemic of politics Science 299 5607 2003 625
39. K. Kitamura The pill in Japan: Will approval ever come? Family Planning Perspectives 31 1 1999 44 45
40. P.L. Martin Potency and pregnancy in Japan: Did viagra push the pill? Tulsa Law Journal 35 2000 651 676
41. E.F. McElmeel Legalization of the birth control pill in Japan will likely Reduce reliance on abortion as the primary method of birth control Pacific Rim Law and Policy Journal 8 1999 681 703
42. Medication Abortion (N.D.). Mifepristone/misoprostol regimen. Medication abortion: Facts and information for healthcare professionals. Retrieved July 2004, from: http://www.medicationabortion.org/mifepristone/index.html.
43. NARAL Foundation (N.D.). The Fight for mifepristone (RU 486). Retrieved July 2004, from: http://www.naral.org/facts/fight_for_ru486.cfm.
44. E.P. Newhall, and B. Winikoff Abortion with mifepristone and misoprostol: Regimens, efficacy, acceptability and future directions American Journal of Obstetrics and Gynecology 183 2 Suppl 2000 S44 S53
45. R.F. Ochs Pharmaceuticals: The battle for control in the 21st century Cleveland State University Journal of Law and Health 10 1995/1996 297 341
46. N. Ogawa, and R.D. Retherford Prospects for increased contraceptive pill use in Japan Studies in Family Planning 22 6 1991 378 383
47. S. Okie Pulling abortion pill would not be difficult; FDA rules on "fast-track drugs" could allow Bush administration quick removal The Washington Post (Sect. A: 5) 2001
48. Pfizer (1999). Patient summary of information about viagra. Pfizer viagra, The FDA approved impotence pill. Retrieved July 2004, from: http://www.viagra.com/consumer/general/importantinfo.asp.
49. Pfizer (N.D.a). About viagra. viagra: The official site of Pfizer - For consumers. Retrieved July 2004, from http://www.viagra.com/consumer/aboutViagra/ index/asp.
50. Pfizer (N.D.b). Pfizer Japan, Inc. corporate profile: Introduction. Retrieved July 2004, from: http://www.pfizer.co.jp/pfizer/english/company/ introduction/index.html.
51. Pharmaceutical Laws and Regulations (2001). Pharmaceutical administration and regulation in Japan: 2001.4. Information in english on Japan regulatory affairs: English regulatory information task force, Japan pharmaceutical manufacturers association.
52. Population Council (2001a). How mifepristone works. Momentum. Retrieved July 2004, from: http://www.popcouncil.org/publications/momentum1200_1_sidebar. html.
53. Population Council (2001b). Mifepristone: A chronology. Momentum. Retrieved July 2004, from http://www.popcouncil.org/publications/momentum/ momentum1200_1b.html.
54. Randal IV, B., (2001). The US drug approval process: A primer. (CRS report for Congress. Order Code RL30989). Washington DC: Congressional Research Service.
55. Ratanawijitrasin, S., & Wondemagegnehu, E. (2002). Effective drug regulation: A multicountry study. Geneva, Switzerland: World Health Organization.
56. B. Reppert Politics in the lab hits US scientific integrity Christian Science Monitor 2004 11
57. E.A. Silverberg Looking beyond judicial deference to agency discretion: A fundamental right of access to RU 486? Brooklyn Law Review 59 4 1994 1551 1615
58. D. Sipp 'Fast-track' drug approvals hit speed bumps in Japan National Medical 10 9 2004 883
59. S. Snider The pill: 30 years of safety concerns FDA Consumer Magazine December 1990
60. I.M. Spitz, C.W. Bardin, L. Benton, and A. Robbins Early pregnancy termination with mifepristone and misoprostol in the United States New England Journal of Medicine 338 18 1998 1241 1247
61. R. Steinbrook Waiting for plan B - the FDA and nonprescription use of emergency contraception New England Journal of Medicine 350 23 2004 2327 2329
62. The Daily Yomiuri (1998). Ministry panel approves production, sale of Viagra. The Daily Yomiuri (Tokyo), 2.
63. The Daily Yomiuri (1999). Ministry says two die after taking Viagra. The Daily Yomiuri (Tokyo) (p. 2).
64. Union of Concerned Scientists (2004). Scientific integrity in policymaking: An investigation into the Bush administration's misuse of science. Cambridge, MA: February 2004. Retrieved June 2004, from: http://www.ucsusa.org/ global_environment/rsi/page.cfm?pageID=1322.
65. 21 USC. Sect. 356 Fast Track Products. (1997). Fast track products. 21 USC. Sect. 356.
66. D. Willman How a new policy led to seven deadly drugs The Los Angeles Times 2000, Dec 20
67. B. Winikoff, C. Ellertson, B. Elul, and I. Sivin Acceptability and feasibility of early pregnancy termination by mifepristone-misoprostol. Results of a large multicenter trial in the United States. Mifepristone clinical trials group Archives of Family Medicine 7 4 1998 360 366
68. Wondemagegnehu, E. (1999). Effective drug regulation: What can countries do? (Document WHO/HTP/EDM/MAC(11)/99.6). Geneva, Switzerland: World Health Organization, Essential Drugs and Medicines Programme.
69. WuDunn, S. (1999). Japan's tale of two pills: Viagra and birth control. The New York Times. Sect. F: 1 (col. 4).
70. M. Zeilenger Japan oks viagra in record time San Jose Mercury News 1999, January 26 1A