What a discouraging process. On the FDA's side, they cannot answer questions
on the status of a drug under investigation. On the side of Janssen, the
manufacturer, they also have little to say about drugs that are in FDA
investigation.  I was unable to get any information whatsoever regarding how
far in the process of approval domperidone was, or if there were any
significant concerns or obstacles.

I also inquired as to what it would take to have domperidone reviewed for
official use as a galactogogue. What was shared with me is that the
information that floats in from doctors who use the drug is important, but
even more important is the scientific literature. So, we need to send along
anything that we have so far, and we need to be writing up and publishing
what we are doing now.

This is a plea to practitioners, most especially MDs but everyone else as
well, to consider writing up your professional experiences or do an official
study, and publish it.   I realize that most of the official experience with
this drug is with non-US health practitioners, who have less of a stake in
this process. But, if you would be willing to share your knowledge, it may
help us along. Correspondence can be directed to:

Attn:Clinical Research, Domperidone
P.O. Box 200
Titusville, New Jersey   08560-0200.
USA
-------------------------
Lisa Marasco, BA, IBCLC
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-------------------------

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