Re: Access to drug information in France
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Paris, April 11 1997, For immediate release
Prescrire demands greater Transparency by French Medicines Agency
The French independent drug bulletin La revue Prescrire has asked
politicians and the head of the French Medicines Agency to explain the high
level of secrecy that is practised by the French Medicines Agency.
Prescrire accuses the Agency of withholding information from the public and
points out that citizens have the right to answers to the following
questions:
Is the information blackout maintained for political reasons and, if so,
what are these reasons?
Are administrators bowing to outside pressures?
Are they incapable of fulfilling their role?
Are they afraid internal failings will be unveiled?
From Prescrire's own experience in dealing with the French Medicines Agency
the journal concludes that in the four years of existence of the Agency,
there has been no sign of greater openness despite promises to improve
information provision. It is not possible to find out exactly what is
happening at the Agency. Particularly the department responsible for
technical and clinical drug evaluation is operating in secrecy. The journal
has been denied requests to obtain expert reports, documents and minutes of
scientific commission meetings that justify the Agency's decisions.
Prescrire asks the question "Could it be that sound and adequate
documentation is simply lacking ?"
The recent sudden withdrawal of three generics illustrates the absurd
consequences resulting from the extreme lack of transparency in drug
regulatory decision making procedures. Three generic drugs from GNR-Pharma
and Jumer (Diltiazem GNR0, Piroxicam GNR0 and Piroxicam Jumer)
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had been taken off the market in December 1996. Prescrire has approached
the manufacturers and the French Medicines Agency to find out if the
withdrawals followed clinical incidents, or any other events.
GNR-Development and Jumer gave Prescrire the following explanation: "This
measure was decided on in concertation with the medicines agency, following
a review of the different files composing the application for marketing
authorisation: certain clinical data obtained several years previously were
no longer in keeping with current requirements for generic files"
The French medicines Agency has published nothing on the subject, and
refused to give a written reply to Prescrire's request for information.
High-level staff confirmed, off the record, that these provisional
withdrawals resulted from a review of the files, undertaken at the
initiative of an outside body (which was not identified). They stated that
they had no knowledge of any clinical incidents. It appears that checks
made (some at the sites where studies were done in preparation for the
marketing application) revealed abnormalities; this was notably the case of
the bioequivalence assessments, which were not in keeping with current
requirements. However, this information has been obtained off the record
and not made publicly available.
La revue Prescire urges the government and the French Medicines Agency to
act upon the recommendation of the "Uppsala declaration" (Statement of the
International Working Group in transparency and accountability in drug
regulation published by HAI-Europe and the Dag Hammerskjvld Foundation).
The full text of the French translation of the Declaration is published in
the April issue of La revue Prescrire (no 172).
For a free copy of the French language journal La revue Prescrire (no 172)
with the French text of the Statement of the International Working Group in
transparency and accountability in drug regulation please contact:
La revue Prescrire
Ellen 't Hoen.
Tel: + 33 1 47009445
Fax: + 33 1 48065237
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