Healthy Skepticism Library item: 13128

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Vitry A, Lexchin J, Sasich L, Dupin-spriet T, Reed T, Bertele V, Garattini S, Toop L, Hurley E.
Provision of information on regulatory authorities’ websites
Internal Medicine Journal 2008 Mar 11; epub ahead of print
http://www.blackwell-synergy.com/doi/abs/10.1111/j.1445-5994.2007.01588.x

Abstract:

Background: Several organizations have raised concerns about the excessive secrecy maintained by regulatory authorities around the world, in particular in the European Union, France, UK, Canada and Australia. However, limited research has assessed the provision of information by regulatory authorities. This study aimed to assess the type and availability of information provided on the regulatory authorities’ websites.

Methods: Regulatory authorities’ websites in six countries (USA, Canada, UK, France, Australia and New Zealand) and at the European level (European Medicines Evaluation Agency) were surveyed by two reviewers between October 2005 and March 2006. The survey instrument included 16 criteria organized in 3 domains: information on marketed drugs, information on assessment of drugs and information on drug safety.

Results: There was a great variability in the level of information provided. Several medicine agencies did not provide basic information on marketed drugs, such as the summary of products’ characteristics. Information on registration dossiers was scant on most websites except that of the US Food and Drug Administration. The European Medicines Evaluation Agency, the French agency and the Canadian agency released public assessment reports that contained only summarized information of registration data. Only one country, Canada, provided full access to pharmacovigilance data. The periodic safety update reports that companies have to provide regularly to regulatory authorities were not available in any country.

Conclusion: Information on which regulatory authorities base their decisions for licensing new drugs and the rationales behind these decisions were often not publicly available.