Ilyssa E. Hollander, MPH, Social Sectors Development Strategies, Inc, 1411 Washington St, Suite 6, Boston, MA 02118, 508.233.4222, ihollander@ssds.net

Women in the United States waited more than a decade for access to medical abortion, while the Food and Drug Administration approved Viagra in less than six months. Congruently, the Ministry of Health in Japan legalized Viagra in 18 months, while oral contraception was approved 35 years after the ministry received initial applications. Both pharmaceutical review agencies are allegedly founded on safety and efficacy standards, in which objective decisions arise from science and clinical investigations. Analyses of these recent drug approvals show that the Japanese Ministry of Health and the U.S. Food and Drug Administration did not base their decisions on science and health concerns. Instead, agency actions stemmed from social and political pressures surrounding the products under scrutiny. Abortion politics in the United States and sex discrimination, sexual morality issues and national population policies in Japan significantly contributed to the delayed approvals of RU486 and the birth control pill. The repeated denials of these products were exacerbated by the concurrent expedited approval of Viagra in each country. Social and political influences clouded drug approval processes, and pharmaceutical regulations were effectively ignored or manipulated to conform to current ideologies. In addition to generating institutionalized gender bias, 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. These systems must remain credible and objective in order to preserve the integrity of pharmaceutical regulation.

Learning Objectives:

• Analyze discrepancies in certain pharmaceutical approvals compared to FDA and MOH drug laws
• Evaluate the reasons for these unorthodox approvals
• Discuss the ramifications of sociopolitical pressures on drug approvals
• Recognize the need to prevent future manipulation of government regulations to suit political and social ideologies

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.