{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T01:29:28Z","timestamp":1789954168521,"version":"4.0.1"},"reference-count":70,"publisher":"Elsevier BV","issue":"3","license":[{"start":{"date-parts":[[2006,2,1]],"date-time":"2006-02-01T00:00:00Z","timestamp":1138752000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Social Science & Medicine"],"published-print":{"date-parts":[[2006,2]]},"DOI":"10.1016\/j.socscimed.2005.03.046","type":"journal-article","created":{"date-parts":[[2005,7,23]],"date-time":"2005-07-23T12:07:56Z","timestamp":1122120476000},"page":"683-693","source":"Crossref","is-referenced-by-count":12,"title":["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"],"prefix":"10.1016","volume":"62","author":[{"given":"Ilyssa","family":"Hollander","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.socscimed.2005.03.046_bib1","series-title":"Science, politics and the pharmaceutical industry: Controversy and bias in drug regulation","author":"Abraham","year":"1995"},{"issue":"9344","key":"10.1016\/j.socscimed.2005.03.046_bib2","doi-asserted-by":"crossref","first-page":"1498","DOI":"10.1016\/S0140-6736(02)11477-2","article-title":"The pharmaceutical industry as a political player","volume":"360","author":"Abraham","year":"2002","journal-title":"Lancet"},{"key":"10.1016\/j.socscimed.2005.03.046_bib3","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib4","first-page":"881","article-title":"Fatal flaws in the food and drug administration's drug-approval formula","volume":"2003","author":"Bean","year":"2003","journal-title":"Utah L. Review"},{"issue":"4","key":"10.1016\/j.socscimed.2005.03.046_bib5","first-page":"E7","article-title":"The approval of mifepristone (RU486) in the United States: What's wrong with this picture?","volume":"5","author":"Blumenthal","year":"2000","journal-title":"Medscape Womens Health"},{"key":"10.1016\/j.socscimed.2005.03.046_bib6","unstructured":"21 C.F.R. Sect. 314.500 (1999). Applications for FDA approval to market a new drug: Subpart H\u2014accelerated approval of new drugs for serious or life-threatening conditions. 21 C.F.R. Sect. 314.500."},{"key":"10.1016\/j.socscimed.2005.03.046_bib8","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib9","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib10","first-page":"333","article-title":"Assessing the Social Impact of Mifepristone in the United States: A Pro-Choice Perspective","volume":"11","author":"Copelton","year":"2001","journal-title":"Kansas Journal of Law and Public Policy"},{"key":"10.1016\/j.socscimed.2005.03.046_bib11","unstructured":"Cornell, A. (1999). Viagra proves a bitter pill for Japanese women. Australian Financial Review (Sect. International News:8)."},{"key":"10.1016\/j.socscimed.2005.03.046_bib12","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib13","first-page":"1","article-title":"Health and drug policies, making them the top of the agenda: A strategy paper on the development of national drug policies","year":"1995","journal-title":"The Journal of the Dag Hammarskj\u00f6ld Foundation, Development Dialogue"},{"issue":"2","key":"10.1016\/j.socscimed.2005.03.046_bib14","first-page":"11","article-title":"Japan: Seeds of consciousness [abstract]","author":"Domoto","year":"1993","journal-title":"Plan Parent Chall"},{"issue":"15","key":"10.1016\/j.socscimed.2005.03.046_bib15","doi-asserted-by":"crossref","first-page":"1561","DOI":"10.1056\/NEJMe048057","article-title":"The FDA, politics, and plan B","volume":"350","author":"Drazen","year":"2004","journal-title":"New England Journal of Medicine"},{"key":"10.1016\/j.socscimed.2005.03.046_bib16","unstructured":"Effective Medicines Regulations (2003). Effective medicines regulation: ensuring safety, efficacy and quality. WHO Policy Perspectives on Medicines, No. 7."},{"key":"10.1016\/j.socscimed.2005.03.046_bib17","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib18","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib20","unstructured":"Food and Drug Administration (1996). Mifeprex approvable letter. NDA 20-687."},{"key":"10.1016\/j.socscimed.2005.03.046_bib21","unstructured":"Food and Drug Administration (1998a). Viagra approval letter. Application No. 020895."},{"key":"10.1016\/j.socscimed.2005.03.046_bib22","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib23","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib24","unstructured":"Food and Drug Administration (2000a). Mifeprex approvable letter. NDA 20-687."},{"key":"10.1016\/j.socscimed.2005.03.046_bib25","unstructured":"Food and Drug Administration (2000b). Memorandum to: NDA 20-687 MIFEPREX (mifepristone). Population council."},{"key":"10.1016\/j.socscimed.2005.03.046_bib26","unstructured":"Food and Drug Administration (2000c). Mifeprex approval letter. NDA 20-687."},{"key":"10.1016\/j.socscimed.2005.03.046_bib27","unstructured":"Food and Drug Administration (2003). Birth control guide. Retrieved December 2004, from: http:\/\/www.fda.gov\/fdac\/features\/1997\/babyguide2.pdf."},{"key":"10.1016\/j.socscimed.2005.03.046_bib28","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib29","unstructured":"Food and Drug Administration (N.D.b). Mifepristone medication guide. Retrieved October 2002, from: http:\/\/www.fda.gov\/cder\/drug\/infopage\/mifepristone\/medguide.htm."},{"key":"10.1016\/j.socscimed.2005.03.046_bib30","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib31","unstructured":"Food and Drug Administration (N.D.d). Viagra consumer information. Retrieved September 2002, from: http:\/\/www.fda.gov\/cder\/consumerinfo\/druginfo\/Viagra.htm."},{"key":"10.1016\/j.socscimed.2005.03.046_bib32","unstructured":"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."},{"issue":"4","key":"10.1016\/j.socscimed.2005.03.046_bib33","doi-asserted-by":"crossref","first-page":"301","DOI":"10.1111\/j.1728-4465.2000.00301.x","article-title":"Abortion trends in Japan, 1975\u201395","volume":"31","author":"Goto","year":"2000","journal-title":"Studies in Family Planning"},{"issue":"22","key":"10.1016\/j.socscimed.2005.03.046_bib34","doi-asserted-by":"crossref","first-page":"2173","DOI":"10.1001\/jama.282.22.2173","article-title":"Oral contraceptives and women's health in Japan","volume":"282","author":"Goto","year":"1999","journal-title":"Journal of the American Medical Association"},{"key":"10.1016\/j.socscimed.2005.03.046_bib35","unstructured":"IMS Health (N.D.). \u201cThe Pill\u201d finally reaches Japan. Retrieved October 2002, from: http:\/\/www.ims-global.com\/\/insight\/news_story\/news_story_991013.htm."},{"key":"10.1016\/j.socscimed.2005.03.046_bib36","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib37","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib38","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib39","unstructured":"Kamimura, M. (1999). Japan approves \u201cpill\u201d after nearly decade of debate. CNN.com. Retrieved October 2002, from: http:\/\/www.cnn.com\/HEALTH\/women\/9906\/02\/japan.pill.02\/index.html."},{"issue":"5607","key":"10.1016\/j.socscimed.2005.03.046_bib40","doi-asserted-by":"crossref","first-page":"625","DOI":"10.1126\/science.299.5607.625","article-title":"An epidemic of politics","volume":"299","author":"Kennedy","year":"2003","journal-title":"Science"},{"issue":"1","key":"10.1016\/j.socscimed.2005.03.046_bib41","doi-asserted-by":"crossref","first-page":"44","DOI":"10.2307\/2991557","article-title":"The pill in Japan: Will approval ever come?","volume":"31","author":"Kitamura","year":"1999","journal-title":"Family Planning Perspectives"},{"key":"10.1016\/j.socscimed.2005.03.046_bib42","first-page":"651","article-title":"Potency and pregnancy in Japan: Did viagra push the pill?","volume":"35","author":"Martin","year":"2000","journal-title":"Tulsa Law Journal"},{"key":"10.1016\/j.socscimed.2005.03.046_bib43","first-page":"681","article-title":"Legalization of the birth control pill in Japan will likely Reduce reliance on abortion as the primary method of birth control","volume":"8","author":"McElmeel","year":"1999","journal-title":"Pacific Rim Law and Policy Journal"},{"key":"10.1016\/j.socscimed.2005.03.046_bib44","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib45","unstructured":"NARAL Foundation (N.D.). The Fight for mifepristone (RU 486). Retrieved July 2004, from: http:\/\/www.naral.org\/facts\/fight_for_ru486.cfm."},{"issue":"2 Suppl","key":"10.1016\/j.socscimed.2005.03.046_bib46","doi-asserted-by":"crossref","first-page":"S44","DOI":"10.1067\/mob.2000.107950","article-title":"Abortion with mifepristone and misoprostol: Regimens, efficacy, acceptability and future directions","volume":"183","author":"Newhall","year":"2000","journal-title":"American Journal of Obstetrics and Gynecology"},{"key":"10.1016\/j.socscimed.2005.03.046_bib47","first-page":"297","article-title":"Pharmaceuticals: The battle for control in the 21st century","volume":"10","author":"Ochs","year":"1995","journal-title":"Cleveland State University Journal of Law and Health"},{"issue":"6","key":"10.1016\/j.socscimed.2005.03.046_bib48","doi-asserted-by":"crossref","first-page":"378","DOI":"10.2307\/1966451","article-title":"Prospects for increased contraceptive pill use in Japan","volume":"22","author":"Ogawa","year":"1991","journal-title":"Studies in Family Planning"},{"key":"10.1016\/j.socscimed.2005.03.046_bib49","article-title":"Pulling abortion pill would not be difficult; FDA rules on \u201cfast-track drugs\u201d could allow Bush administration quick removal","author":"Okie","year":"2001","journal-title":"The Washington Post (Sect. A: 5)"},{"key":"10.1016\/j.socscimed.2005.03.046_bib50","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib51","unstructured":"Pfizer (N.D.a). About viagra. viagra: The official site of Pfizer\u2014For consumers. Retrieved July 2004, from http:\/\/www.viagra.com\/consumer\/aboutViagra\/index\/asp."},{"key":"10.1016\/j.socscimed.2005.03.046_bib52","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib53","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib54","unstructured":"Population Council (2001a). How mifepristone works. Momentum. Retrieved July 2004, from: http:\/\/www.popcouncil.org\/publications\/momentum1200_1_sidebar.html."},{"key":"10.1016\/j.socscimed.2005.03.046_bib55","unstructured":"Population Council (2001b). Mifepristone: A chronology. Momentum. Retrieved July 2004, from http:\/\/www.popcouncil.org\/publications\/momentum\/momentum1200_1b.html."},{"key":"10.1016\/j.socscimed.2005.03.046_bib56","unstructured":"Randal IV, B., (2001). The US drug approval process: A primer. (CRS report for Congress. Order Code RL30989). Washington DC: Congressional Research Service."},{"key":"10.1016\/j.socscimed.2005.03.046_bib57","unstructured":"Ratanawijitrasin, S., & Wondemagegnehu, E. (2002). Effective drug regulation: A multicountry study. Geneva, Switzerland: World Health Organization."},{"key":"10.1016\/j.socscimed.2005.03.046_bib58","first-page":"11","article-title":"Politics in the lab hits US scientific integrity","author":"Reppert","year":"2004","journal-title":"Christian Science Monitor"},{"issue":"4","key":"10.1016\/j.socscimed.2005.03.046_bib59","first-page":"1551","article-title":"Looking beyond judicial deference to agency discretion: A fundamental right of access to RU 486?","volume":"59","author":"Silverberg","year":"1994","journal-title":"Brooklyn Law Review"},{"issue":"9","key":"10.1016\/j.socscimed.2005.03.046_bib60","doi-asserted-by":"crossref","first-page":"883","DOI":"10.1038\/nm0904-883a","article-title":"\u2018Fast-track\u2019 drug approvals hit speed bumps in Japan","volume":"10","author":"Sipp","year":"2004","journal-title":"National Medical"},{"key":"10.1016\/j.socscimed.2005.03.046_bib61","article-title":"The pill: 30 years of safety concerns","volume":"December","author":"Snider","year":"1990","journal-title":"FDA Consumer Magazine"},{"issue":"18","key":"10.1016\/j.socscimed.2005.03.046_bib62","doi-asserted-by":"crossref","first-page":"1241","DOI":"10.1056\/NEJM199804303381801","article-title":"Early pregnancy termination with mifepristone and misoprostol in the United States","volume":"338","author":"Spitz","year":"1998","journal-title":"New England Journal of Medicine"},{"issue":"23","key":"10.1016\/j.socscimed.2005.03.046_bib63","doi-asserted-by":"crossref","first-page":"2327","DOI":"10.1056\/NEJMp048135","article-title":"Waiting for plan B\u2014the FDA and nonprescription use of emergency contraception","volume":"350","author":"Steinbrook","year":"2004","journal-title":"New England Journal of Medicine"},{"key":"10.1016\/j.socscimed.2005.03.046_bib64","unstructured":"The Daily Yomiuri (1998). Ministry panel approves production, sale of Viagra. The Daily Yomiuri (Tokyo), 2."},{"key":"10.1016\/j.socscimed.2005.03.046_bib65","unstructured":"The Daily Yomiuri (1999). Ministry says two die after taking Viagra. The Daily Yomiuri (Tokyo) (p. 2)."},{"key":"10.1016\/j.socscimed.2005.03.046_bib66","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib19","unstructured":"21 USC. Sect. 356 Fast Track Products. (1997). Fast track products. 21 USC. Sect. 356."},{"key":"10.1016\/j.socscimed.2005.03.046_bib67","article-title":"How a new policy led to seven deadly drugs","author":"Willman","year":"2000","journal-title":"The Los Angeles Times"},{"issue":"4","key":"10.1016\/j.socscimed.2005.03.046_bib68","doi-asserted-by":"crossref","first-page":"360","DOI":"10.1001\/archfami.7.4.360","article-title":"Acceptability and feasibility of early pregnancy termination by mifepristone-misoprostol. Results of a large multicenter trial in the United States. Mifepristone clinical trials group","volume":"7","author":"Winikoff","year":"1998","journal-title":"Archives of Family Medicine"},{"key":"10.1016\/j.socscimed.2005.03.046_bib69","unstructured":"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."},{"key":"10.1016\/j.socscimed.2005.03.046_bib70","unstructured":"WuDunn, S. (1999). Japan's tale of two pills: Viagra and birth control. The New York Times. Sect. F: 1 (col. 4)."},{"key":"10.1016\/j.socscimed.2005.03.046_bib71","first-page":"1A","article-title":"Japan oks viagra in record time","author":"Zeilenger","year":"1999","journal-title":"San Jose Mercury News"}],"container-title":["Social Science & Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0277953605003175?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0277953605003175?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2019,1,24]],"date-time":"2019-01-24T09:27:24Z","timestamp":1548322044000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0277953605003175"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2006,2]]},"references-count":70,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2006,2]]}},"alternative-id":["S0277953605003175"],"URL":"https:\/\/doi.org\/10.1016\/j.socscimed.2005.03.046","relation":{},"ISSN":["0277-9536"],"issn-type":[{"value":"0277-9536","type":"print"}],"subject":[],"published":{"date-parts":[[2006,2]]}}}