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[IP] FDA Approval? (LONG)

Dear friends --

Several threads have recently included comments on whether Humalog or
diluted insulin is approved.  Perhaps some clarification on what this means
may be helpful.

The FDA approves drugs and medical equipment for sale to healthcare
practitioners and/or the public.  The regulation is of the manufacturers and
purveyors, not the users.

Before a new drug (or modification of a drug) or a medical device such as a
drug delivery system (i.e. a pump) may be marketed in the United States, the
manufacturer must demonstrate three things: that the drug (or device) will
do what the manufacturer claims it will do; that the recommended doses are
both effective and minimal for the effect (or the device will accurately
control the dose); and that there are no short term side effects or that
these side effects are well documented and, for the most part controllable.

Once a drug or device is approved for sale, the manufacturer of the drug or
the delivery system (i.e. a pump) may only advertise them for the purposes
for which they are approved.  Since the FDA has only approved buffered
Regular or Velosulin insulin for pump use, all manufacturers selling in the
United States are constrained from suggesting any other insulin be used in
the pump.

This has absolutely no status on how the drug or the delivery system may
actually be used -- only in how it may be marketed.  So, although Humalog is
not approved for use in pumps, there is nothing illegal, unethical, or
irregular about using Humalog in a pump.  Similarly, if Disetronic is
providing pre-filled cartridges for use in pumps (and it is marketed that
way!) then it is buffered Regular, not Humalog.  If, however, Disetronic is
marketing the cartridges for use in their pen (with no mention of using them
in pumps), but it will work in a pump anyway, then there is no reason that
it couldn't be filled with Humalog.  I suspect that, if that is the case,
then the records of sale will indicate that the recipient is getting it for
use in a pen (and they'll probably GIVE you one to make sure you have one --
just in case).

So don't fret too much about what's approved for use in your pump.  You
aren't doing anything improper by using Humalog, diluting your insulin to
U50 or buying U40 for use in your pump.

Jim Handsfield
Centers for Disease Control and Prevention
mailto:email @ redacted OR
mailto:email @ redacted

The opinions expressed are my own and do not necessarily represent those of
the Centers for Disease Control and Prevention, the United States Public
Health Service or any other agency of the United States government.
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