E-DRUG: expired drug donations?

E-DRUG: expired drug donations?
-------------------------------

Dear E-druggers,

May I make a few remarks as "devil's advocate" - having worked for a
number of years in drug registration? I fully understand that many
people are very upset by the quoted article - but where lies the
fault? To my opinion in the combination of industry's wish to sell
and the drug authority's wish to do as little as possible (and
certainly not intensive quality control) by accepting a common
deadline of three years. It is absolutely true that many simple
chemical compounds remain stable for a much longer period of time
than just 3 years. On the other hand, some drugs decay in unsuitable
environments long before that deadline (malaprim, nitroglycerine,
most antibiotics). In the present situation we simply do not know.
Any housewife knows that you cannot keep fresh milk and
green vegetables in the fridge for more than a few days, and that
most cheese and sausages keep for many months - Imagine that we would
accept a common deadline of 10 days for all foods!

So we should probably stress for a more flexible approach in drug
registration and do some good research on shelf life under varying
circumstances (as WHO/DAP has done with some drugs in the past).

Leo Offerhaus MD PhD
Chopinstraat 9 NL-1077 GL Amsterdam The Netherlands
Tel. 0031-20-6762434 Fax 0031-20-6756590
E-mail LO@EURONET.NL, CompuServe 71530,15

--
Send mail for the `E-Drug' conference to `e-drug@usa.healthnet.org'.
Mail administrative requests to `majordomo@usa.healthnet.org'.
For additional assistance, send mail to: `owner-e-drug@usa.healthnet.org'.