Hollander Ilyssa
Social Sectors Development Strategies, Inc., 1411 Washington St., Suite 6, Boston, MA 02118, USA.
Soc Sci Med. 2006 Feb;62(3):683-93. doi: 10.1016/j.socscimed.2005.03.046. Epub 2005 Jul 22.
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.
在美国，伟哥向食品药品监督管理局提交申请后不到6个月就获得了批准，而堕胎药在提交申请4年后才获批，且在首次允许进行研究17年后才获批。同样，日本厚生省在6个月内就使伟哥合法化，而口服避孕药在厚生省收到首次申请35年后才获批。每个国家的药品审评机构都基于安全性和有效性标准建立，其中客观的决策源自科学和临床研究。对这些近期药品批准情况的分析表明，结论可能并非仅仅基于科学和健康考量。相反，药品审评机构的行动和药品法律的应用似乎受到了受审查产品周围社会和政治压力的影响。在美国，堕胎药审评过程中，药品法规实际上被忽视或操纵，在日本则应用不一致——最终产生的结果恰好符合当代社会政治观念。这种对法规的漠视对公众健康、国家消费者信任和制药行业都有严重影响。必须确保外部压力不影响药品批准程序。
