Yesterday evening I attended a presentation by  Susan F. Wood, Ph.D.,
Director, U.S. Food and Drug Administration's Office of Women's Health.

After her talk, I asked her about the FDA's directive against compounding
domperidone and use of the drug by breastfeeding women.  She was completely
familiar with the situation, and clearly concerned about the need for a
reliable safe drug to help women with low milk production.   She said that
the she was not at liberty to divulge the full reasoning behind the
statement.  If people are interested in more information, she said they
would have to ask the drug manufacturers.  The FDA cannot reveal proprietary
data taken into account in making this decision.



I was fully prepared to press her long and hard about financial benefits
that might accrue to drug companies who may be coming out with new
preparations.  Her concern was very clearly for safety issues that she could
not discuss.   She apologized for having to take the "trust me" position,
but she held firm in her statements.  After speaking with her, I was
convinced that there is information about this drug that we do not have.



Basically, I am a very skeptical person (as those of you who know me can
attest).  But, I believed Dr. Woods.  I also remember that it was the FDA
(or more specifically, women at the FDA) who kept thalidomide off the market
-in spite of considerable pressure by American drug companies and in spite
of the wide-spread approval and use of the drug in Europe.   So I am going
to give the FDA the benefit of the doubt on this one, and willingly comply
with the directive until more information is available establishing the
safety of this drug.



Judy Hopkinson, PhD, IBCLC

Assistant Professor

Baylor College of Medicine

phone: 713 798-7008

fax:       713 798-7098




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