FDA Approval of AIDS Drugs - 2 items (3)
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I have read Peter Burgess' submission and find that I completely
disagree with him on his suggestion that these products be ex-
empted from scrutiny. This is because of certain reasons which I
hope we can agree upon.
First and foremost let me state I am from Uganda and I com-
pletely agree with what our minister said and the chairman of
the board of NDA.
1) This is not an emergency drug that needs to be bought today
or tomorrow and neither is it much cheaper than the available
already registered products, this means there is no rush to have
these drugs 'yesterday' as some would have us believe.
2) There are established standards in the four countries, stan-
dards and regulations that have not come up all of a sudden but
have been drawn up to cater for all situations pertaining to the
situations in those countries, violating these sets the wrong
precedent and opens the door for those who think bug business is
always right.
3) There is a well established system of bringing in emergency
drugs and this can be used in case of emergencies.
4) There is a fast track system of getting a product onto the
register in Uganda and this can be used, it was used for COARTEM
and took about a year.
4) What are the factories and manufacturers hiding? why are they
not willing to be subject to regulations? or are they just in a
rush to get part of the big money in the Global Fund kitty? now
that they know Generics are the way to go for poor countries.
5) Whom will our countries' populations hold accountable in case
of any problems with these drugs in the future... the FDA or
their countries?
Let me say this again......THIS IS NO EMERGENCY SITUATION...!
It is an emergency only for the big Pharma Co's which are eager
to feed off our illness and poverty while appearing sanctimoni-
ous.
Kigozi Isaac
mailto:kigoziisaac76@yahoo.co.uk