Well, this ought to surprise no one:  Politics affects medicine.

First: defintions.  (There is a reason this is always the first section in
any law or regulation you will read.)  The Food and Drug Administration
(FDA) in the USA regulates drugs that are mass-produced, mass-marketed and
mass-distributed.  The idea is that if some pharmaceutical company is going
to be producing hundreds of millions of little pills a day, placing them in
handy pre-counted and pre-labeled packages, someone oughta make sure the
drugs are safe, and the manufacturing processes are too.

Compounding pharmacists, however, work one-on-one with doctors and
patients.  They fill one prescription at a time, one pill at a time, in
response to the prescription made by one doctor treating one patient.  We
don't need the FDA swooping down because -- ta da -- the safety mechanisms
(the doctor-patient-druggist relationship) protects for the general overall
safety of the patient and drugs involved.

Here's the kicker:  The Food Drug and Cosmetic Act allows a
doctor-patient-compounding pharmacist to do this EVEN IF the drug involved
is NOT FDA-approved.  Why?  Because a safety net is in place:  this is a
one-on-one medical evaluation and decision made by one doc and one patient
and one pharmacist.  By the same token, the law says that if a drug is
FDA-approved for ANY indication, a doctor may prescribe that drug for any
OTHER use for an individual patient's care.  This is called off-label use.
Why?  The FDA has done its swooping, by approving the drug, so a doctor may
use that as a general assurance of the drug's safety while discussing the
off-label use of the drug with the mother.  (Note that there are significant
liabilities if the *manufacturers* try to *market* the drug for its
off-label use.  That is a no-no.  One doctor-one patient-one druggist is
never a no-no.)

The dire warning from the Food and Drug Administration (FDA) regarding those
domperidone-related "cardiac incidents" involved, I understand, critically
ill patients getting the domperidone intravenously.  And the incidents
occurred 20 years ago.  And the FDA happily allowed for domperidone use
(orally) in the intervening years to treat gastric reflux.  All of which
ignore the physiologic processes happening when a mother takes it orally,
and it transfers into her breastmilk.  And lest we forget, infants are
regularly given the drug  orally *for its original gastric reflux
indication.*  (So I guess it is safe for an infant to get it full strength,
orally, but risky to get it through the tremendous filter that breastmilk
customarily represents.  Go figure.)

But we live in the real world.  The Practice of Medicine in the USA has
become, largely, an exercise in the Avoidance of Litigation.  And most
decision-makers have to operate on "the headlines only."  If you were the
risk manager in a medical practice, having to pay the *hundreds of
thousands* of dollars it costs --annually -- to provide malpractice
insurance to your doctors, wouldn't YOU quake in your boots if the FDA came
huffing and puffing and stomping around, intimating -- wholly erroneously --
that doctors cannot prescribe domperidone for use as a galactogogue?  Heck
no. I'd reach for my Alka Seltzer first, stay NO MORE DOM second, and ask
questions later.

Is that right?  No.  Is it legal for FDA?  No.  Does it happen?  Each and
every day.  Here we are on Lactnet, probably the most lactation-savvy crowd
you could find, and we are all asking "Huh" Wazzup" and "When" about
domperidone.  It shouldn't surprise us that those who are *not* as invested
in BF as we are not taking the time to parse out the truth about these FDA
warnings.

And now ask yourself:  imagine you are a doc, being pressured NOT to
prescribe the drug.  You know your risk managers are wrong.  But they are
telling you:  do it our way (NO DOM) or leave.  Period.  Or your state
licensing board is -- again, erroneously -- threatening to yank your license
if you cotinue to prescribe.  Who wants to take on that Titanic battle?  In
this economic age?  What good is it to have a BF-friendly doc who suddenly
finds herself without a job or license to practice?

As a last cycnical word .. I can't put my fingers on the source, but I
remember learning in 2004 (when FDA came down so hard on domperidone) that a
critical first-step in securing a patent and market exclusivity on a new
drug, being mass-marketed for a new use, is to have no such drug on the
current market.  Whacha bet one of our friends in the pharma industry is
waiting to roll out its New and Improved and Really Expensive galactagogue,
containing domperidone, in the near future?
 .
Liz Brooks JD IBCLC
Wyndmoor, PA, USA

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