E-DRUG: MSF on new USA FDC policy / FDA procedure
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[What do E-druggers think about the new USA FDC procedure? Below a comment
from MSF. WB]
MSF statement on US government announcement of new procedure for reviewing
the safety and efficacy of fixed-dose combinations and co-blisters of
antiretrovirals
May 18, 2004
On May 16, the United States announced that the US Food and Drug
Administration would set up a "rapid process" for reviewing fixed dose
combinations (FDCs), co-packaged products, and single ingredient
antiretrovirals (ARVs) for the treatment of HIV/AIDS, particularly for use
in programmes financed by the US President's Emergency Plan for AIDS Relief
(PEPFAR).
It is positive that the US has finally recognized the importance of
treatment simplification and the central role of FDCs in scaling up ARV
therapy and promoting adherence in developing countries. This recognition
is long overdue.
However, MSF believes that, rather than creating a unilateral system which
unnecessarily complicates and delays matters, the US should support the
existing WHO prequalification system, and lend the technical expertise of
FDA officials to the process. The US has repeatedly been invited and
encouraged to take part in the prequalification project and has
consistently refused to collaborate.
The WHO pre-qualification process is based on international standards,
guidelines and norms that allow quality and safety assessment of medicines.
These standards have been developed and approved by the WHO Expert
Committee system involving all WHO member states and WHO governing bodies,
and the prequalification project has ongoing technical input from
regulatory authorities in both developed and developing countries.
It is the World Health Organization, and not the US Food and Drug
Administration, which has the mandate to set international standards for
quality, safety, and efficacy. There is no justification for further
delaying the availability of medicines that are already saving lives and
that are already certified by the WHO as meeting stringent international
standards for quality, safety, and efficacy.
M�decins Sans Fronti�res provides ARV therapy to more than 13,000 people
with HIV/AIDS in over 20 countries in Africa, Asia, Latin America, and
Eastern Europe. More than half of our patients are on WHO prequalified
generic triple FDCs. We know from our direct field experience that these
generic FDCs are prolonging lives. Patients' CD4 cell counts are rising,
they are gaining weight, they are experiencing fewer opportunistic
infections, and they are adhering to their two-pill-a-day regimens at
unusually high rates ? in short, these ARVs are transforming HIV from a
death sentence into a somewhat manageable illness, even in some of the
poorest and most remote settings.
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