I received my newsletter in the mail yesterday. Interesting article on
domperodone...nothing we haven't heard so far. However, there was a nice
little sidebar to the article:

"ABM Board Members Join USBC Phone Conference with FDA about Domperidone
MaryAnn O'Hara, MD, FABM

   Several ABM board members were asked to serve as experts for the US
Breastfeeding Committee in its July 29 phone conference about domperidone
with the US Food and Drug Administration. this call sought to clarify the
reasons behind the FDA's warning and to provided expert input and request
further consideration by the FDA. The willingness of high level FDA
officials to meet with the USBC representatives and the appointment of a
point person for breastfeeding issues indicate that the FDA is taking these
concerns seriously.

   In response to questions about why the FDA had focused so much attention
on domperidone at this time, representatives responded that they were
alerted to the issue by unspecified "outside [the FDA] entities" and became
concerned about an increase in the volume of online sales and compounding
of the drug as well as reports that "many" nursing women were using it.

   FDA representatives stated that they felt confident in their reasons for
the ban but that FDA employees have constraints about what specific
information they could discuss due to intellectual property laws protecting
manufacturers. USBC Chair Amy Spangler offered to pursue two suggested
options to find out if additional information exists that the FDA cannot
discuss publicly: 1) check the voluntary registry of applications for drug
approval, and 2) use the Freedom of Information Act to request domperidone-
related information from the FDA.

   On a positive note, FDA officials expressed a desire to make safe and
effective galactogogues available to women. Toward this end, they offered
to provide guidance to any entity wanting to submit an application for
approval of a specific galactogogue. Dr. Thomas Hale and others offered to
contact select pharmaceutical companies to see if they would be willing to
seek FDA approval needed to make the drug legally available to US women,
possibly through the "orphan drug" program."

Hmmmm....wonder who the 'unspecified "outside [the FDA] entities"' are????
Any one want to venture a guess??

Ellen Penchuk, IBCLC, RLC

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