norml11 - Page 34
Page 34
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of Appeals ham condemned°
The Admin:istra_or in that third final rule made a series of further findings =
Again, the central concern in these findings was _he con_ent of test results and
the Sufficiency or adequacy of. studies and scientific reports. A careful reading
-_ 6f the criteria considered in othe ffDMA third fi:nal order reveals that the
Administrator wasrea]|y considering the question: Should the drug be accepted
for medical use?; rather than the question: Has the drug been accented for
medical use? 8y considering little else but. scientific test results and reports
the Administrator was making a determination as to whether or not, _n his opinion,
MDMA ou h_ to be accepted for medical use in treatment.
The Agency's arguments _n the present case ape to the same effect. In a
word, they address the wrong question_ !t is cot for isis Agency to tell
doctors whether they should or should not accept a drug or substance for medical
uses The statute directs the Administrator _erely to ascertain whether, in
fact, doctors ha#e done so.
The _DP_A third fina] order mistakenly looks to FDA criteria for guidance in
choosing criteria for DEA to app_y_ Under the Food, Drug and Cosmetic Act the
FDA is deciding - properly, under that statute - whether a new drug should be
introduced into interstate commerce. Thus it is appropriate for the FDA to rely
heavily on test results and scientific inquiry to ascertain whether a drug is
effective and whether it is safe° The FDA must look at a drug and pass judge_
ment o_ _ts _nt:rinsic qualities_ The DEA, on the other hands is charged by 21
UoS.C. § 812(b)(_)(B) and (2)(B) with ascertaining what it is that other people
have done with _respect to a drug or substance: _Have they accepted it?;" not
"Should they ac_.e_t it?':
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