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  

Oleh:

Hollander, Ilyssa

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: Social Science & Medicine (www.elsevier.com/locate/sosscimed) vol. 62 no. 3 (Feb. 2006), page 683-693.
Topik: PHARMACEUTICALS; pharmaceuticals; regulation; drug approval; viagra; USA; japan; medical abortion; oral contraception

Ketersediaan

Perpustakaan Pusat (Semanggi) Nomor Panggil: SS53.1 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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In the united states, viagra was approved in less than 6 months of it application to the food and drug administration, while the medical abortion pill was approved 4 years after its applicaton, 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 appliations. The pharmaceutical review agencies in each country are founded on safety and efficacy standards, in which obejctive 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 concers. 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 n the united states during the review process for medical abortion, and were applied incosistently in japan, ultimately yielding results that happened to conform to contemporary socio political beliefs. Such disregard of legislation holds serious ramifications for public health, national consumer trust and the pharmaceutical industry. It is imperative that external pressuer remain outside the scope of drug approval process.

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