norml11 - Page 33
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Thai third fina] rule dealing with _D_IA is dealing with a synthetic, "sim-
ple", _sing_e-action _ drug. In'hat might be appropriate criteria for a '_Simple '_
dru 9 ]ike MOMA may _ot be appropriate focl a '_complex" substance with a number
of active components. The criteria applied-to _IDMA, a synthetic drug, ace not
z -
appropriate for applicatic_n to marijuana, _hich is a natural plant substance.
The First Circuit Court of Appeals in :the MDMA case told the Administrator
that he should not treat the absence of FOA interstate marketing approval as
conclusive evidence of lack of currently accepted medical use. The court did
not forbid the Administrator from considering the absence of FDA approval as a
factor when determining the existence of accepted medical use. Yet on remand,
in his third final order, the Administrator adopted by reference Ig of the num-
bered findings he had made in the first fioa] order° Each of these findings had
to do with requirements imposed by FDA for approval of a cow drug application
(NOA) or of an _nvestigational _ew drug exemption ([NO). These requirements
deal with data resulting from controlled studies and scienCifical_y conducted
investigations and tests.
Among those findings incorporated into the third final MDMA order from the
first, and relied on by the Administrator, "was the determination and recommenda-
tion of the FDA that the drug there in question was not "accepted". In relying
on the FDA's action the Administrator apparently overlooked the fact that the
FDA clearly stated that it was interpreting, _accepted medical use _' in the Act as
being equivalent to receiving FDA approval for lawful marketing under the FDCA.
Thus the Administrator accepted as a basis for his MDMA third final ru]e the FDA
recommendation which was based upon a statutory interpretation which the Court
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