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.
abstract: In the United States, Viagra was approved in less than 6 months of its application to the Food and Drug Administration, while the medical abortion pill was approved 4 years after its application, and 17 years after research was first permitted. Congruently, the Ministry of Health in Japan legalized Viagra in 6 months, while oral contraceptives were approved 35 years after the ministry received initial applications. The pharmaceutical review agencies in each country are founded on safety and efficacy standards, in which objective decisions arise from science and clinical investigations. Analyses of these recent drug approvals demonstrate that conclusions may not have been based simply on science and health concerns. Instead, agency actions and application of pharmaceutical law appear to have been influenced by social and political pressures surrounding the products under scrutiny. Pharmaceutical regulations were effectively ignored or manipulated in the United States during the review process for medical abortion, and were applied inconsistently in Japan--ultimately yielding results that happened to conform to contemporary sociopolitical beliefs. Such disregard of legislation holds serious ramifications for public health, national consumer trust and the pharmaceutical industry. It is imperative that external pressures remain outside the scope of drug approval processes.
authors.affiliation: Social Sectors Development Strategies, Inc., 1411 Washington St., Suite 6, Boston, MA 02118, USA. ihollander@ssds.net
authors.forename: Ilyssa
authors.initials: I
authors.lastname: Hollander
mesh_terms: D001294:Attitude to Health; D003281:Contraceptives, Postcoital / Q000592:standards* / Q000600:supply & distribution; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D004345:Drug Industry; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D010879:Piperazines / Q000592:standards* / Q000600:supply & distribution; D011057:Politics; D011640:Public Policy; D011687:Purines / Q000592:standards / Q000600:supply & distribution; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000592:standards* / Q000600:supply & distribution; D035502:Trust; D014481:United States; D014486:United States Food and Drug Administration; D016387:Women's Health
chemical_list: D003281:Contraceptives, Postcoital; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate