APPENDIX
Supplementary information provided by
the Consumers' Association relating to its evidence
of 31 March 1998
In 1995 we requested information from the Food
and Drug Administration (FDA) under the US Freedom of Information
Act about an antibacterial drug called co-trimoxazole (brand names
Septrin and Bactrim). The FDA sent us over 300 pages of data about
the licensing of the drug and their Summary Basis of Approval
(the dossier of data on which the approval was based). This included:
clinical trial data; pharmacological, biological and chemical
evaluation; information about packs and labelling; and correspondence
between the FDA and the companies concerned. The FDA also sent
us details of drug side-effect monitoring after approval was given.
It is interesting to contrast this with the
information the Medicines Control Agency (MCA) sent us on the
same drug: only 22 pages of data. Although details were provided
on adverse drug reactions and information which had been given
to doctors, we did not receive anything like the detail we obtained
from the FDA (for example, there was no summary basis of approval
or similar document).
7 April 1998
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