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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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