Trading risks for markets: The international harmonisation of pharmaceuticals regulation

Unhealthy Pharmaceutical Regulation

“…That concern applied not only to national systems within Europe before 1995, but also more internationally (Abraham and Reed 2001).…”

“…In response, in 1988, the first 'mission' of government regulators and industry representatives from the pharmaceutical sector in Europe was sent to Japan to discuss bilateral harmonization of regulation between Japan and the EU, so that Japanese markets might become more accessible to the European drug industry (Wyatt-Walter 1995). However, given the importance of the US market (about half the world market), the European pharmaceutical industry was unenthusiastic about solely bilateral harmonization with Japan, so the International Federation of Pharmaceutical Manufacturers Association (IFPMA) took responsibility for organizing trilateral meetings between the industry and government regulators in the pharmaceutical sectors of the EU, Japan, and the US from 1990 (Abraham and Reed 2001). These meetings became established as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).…”

Power, expertise and the limits of representative democracy: genetics as scientific progress or political legitimation in carcinogenic risk assessment of pharmaceuticals?

“…In the overall non-clinical safety evaluation of a new drug, the lifespan carcinogenicity study in rodents consumes the most time and resources; taking over 3 years and costing over 1 million US dollars per compound tested (Abraham and Reed 2001). The results of these studies can have a major impact on the approval of a product (Contrera 1996).…”

Shadow science: Zyprexa, Eli Lilly and the globalization of pharmaceutical damage control

“…corporate strategic logic (vis-à -vis risk, for instance) is but one element in a larger dialectic involving medical authority (Abraham and Lewis, 2002), pharmaceutical citizenship (Ecks, 2008), emergent bioethics (Petryna et al, 2006), regulatory histories and cultures (Abraham and Reed, 2001;Abraham and Davis, 2009), and other contingencies relating to current psychiatry and to specific classes of therapeutic drugs. Mental illness is a rapidly expanding cause of disability and social suffering.…”