vol2 - Page 37
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That thihd final rule dea)ing with MDMA is dealing with a synthetic, "sim-
._/_,
ple", "single-action" drug. What might be appropriate criteria for a "simple"
drug like MDMA may mot be appropriate for a "complex" substance with a number
of active components. The criteria applied to MDMA, a synthetic drug, are not
c,.
appropriate for appllcation to marijuana, which is il natural plant substance.
The FiRst Circuit Court of Appeals in the MDMA case told the Administrator
that he should not treat the absence of FDA interst_ite marketing approval as
conclusive evidence of lack of currently accepted _;dical use, The court did
not forbid the Administrator from considering the absence of FDA approval as a
factor when determining the existence of accepted _m_dical use. Yet on remand,
CC_
in hls third final ordem, the Administrator adopted by reference 18 of the num-
bered findings he had made in the first final order.. Each of these findings had
todo with requiroments imposed by FDA for approval of a new drug application _
(NDA) or of an in.vestlgatlonal new drug exemptlon (_ND), These requirements
deal wlth data resulting from controlled studies and scientifically conducted
investigations and tests.
Among those findings incorporated into the third final MDMA order from the
first, and relied o_ by the Administrator, was the determination and recommenda-
tion of the FDA that the drug there in question was not macce pted=, In rel,yT_g
i
on the FFDA_s action the Administrator apparently ov(_rlooked the fact that the
FDA clearly si:_f,ed that i_:_,__.Ini:_rpre_'fng:"acI:_p._:medical use" in the Act as
being equivalent to receiving FDA approval for lawf_:l marketing under the FDCA,
Thus the Administrator accepted as a basis for his MDMA third final rule the FDA
recommendation which was based upon a statutory inte_rpretation which the Court
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