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effectives # and, therefore, the only d_m_ with a mcurrently
accepted medical use in treatment in the United States. _ Without
question, this is not the case for anti_metiCes IOP-reducing
drugs, those drugs used to treat spasticity, or any other drug.
As DEA notes in its brief, a number of antiemetics have received
NDA_approval and according to DEASs standards have an #accepted
medical use # even though only one of those drugs can, according
_o the same standards be the wmoet effective # antiemetic.
Clearly this illogical, chaotic, and disingenuous standard is
irrational and inappropriate°
The practice of medicine -- an area into which the
federal government may not intrude _Q/ _- is the scienceand art
of determining which drug is most appropriate for a particular
patient in agiven Situation_ DEA indisputably lacks the
authority to make this wholesale determination. II/
Second, DEA alleges that the only means of determining
#efficacy_ is through the use of double-blinds randomized
studies, i2J This argument is baseless. FDA requires adequate
I_Q/ ACT Brief at 9_ no28o mThe FDCA, however, never uses the
phrase 'medical use. _ In fact, FDA has no authority to intrude
upon the practice of medicine. _
ii! In its brief, DEA contends that a rescheduling decision is
in effect a regulation of the practice of medicine® While this
may or may not be the case, it has nothing to do with the deter-
mination of what is "accepted medical use. N To say that DEA is
the ultimate arbiter determining what is an accepted medical use
would unquestionably constitute a regulation of the practice of
medicine never intended by Congress. To require that a drug be
perfect for every patient prior to recognizing its acceptance
for purposes of the CSA is a ludicrous interpretation of
Congressional intent. It is extremely doubtful that any drug
known to man could satisfy DEA's standard.
12/ DEA Brief at _ 43-44; pp. 28-29, 96_97.
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