PHA-Exch> Provision of drug information by regulatory authorities

[David Legge]

Provision of information on regulatory authorities' websites
A. Vitry,  J. Lexchin, L. Sasich, T. Dupin-Spriet, T. Reed, V. Bertele,
S. Garattini, L. Toop , E. Hurley 
Internal Medicine Journal 
Vol 38, Issue7, pp 559-567
 
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.
 
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20080721/3022f141/attachment-0001.html>