Healthy Skepticism Library item: 18106

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Publication type: Journal Article

Abraham J, Reed T.
Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?
Soc Sci Med 2003 Jul; 57:(2):195-204
http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VBF-47K2FVB-2&_user=10&_coverDate=07/31/2003&_rdoc=1&_fmt=high&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=2fe98ef29b4b809b0cfa04b1bc768e52

Abstract:

The most significant institutional entity involved in the harmonisation of drug testing standards worldwide is the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which comprises the three pharmaceutical industry associations and regulatory agencies of the EU, US and Japan. It is often claimed that such harmonisation will both accelerate the development and approval of new drugs and preserve safety standards, if not strengthen safety regimes. Drawing on extensive documentary research and interviews, this paper systematically examines whether the efforts by the ICH to improve industrial and regulatory efficiency by harmonising drug testing requirements is likely to raise, maintain or compromise safety standards in carcinogenic risk assessment of pharmaceuticals. The evidence suggests that, in the field of carcinogenicity testing, the ICH management of international harmonisation of medicines regulation is not achieving simultaneous improvements in safety standards and acceleration of drug development. Rather, the latter is being achieved at the expense of the former. Indeed, the ICH may be converting permissive regulatory practices of the past into new scientific standards for the future. These findings are significant as many expert scientific advisers to drug regulatory agencies seem to have accepted uncritically the conclusions reached by the ICH, which may affect a potential patient population of half a billion and tens of thousands of clinical trials.

Keywords:
Animals Carcinogenicity Tests* Drug Approval/organization & administration* Drug Industry/legislation & jurisprudence Drug Industry/standards* European Union Humans International Cooperation* Japan Mice Pharmaceutical Preparations/adverse effects* Pharmaceutical Preparations/standards Public Policy Risk Assessment* Safety United States