vol2 - Page 38

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 Agai'n,..bh.e _,_n_cr_l _co_r_. _n t_h._se ?h_di_gs; _ T._ .co_t_1: of test r_sul ts and
 .._ the sufficiency or adequacy of studies _nd sclent_?i¢ reportso A careful reading
 of the criteria considered _n the MDMA third final order reveals that the
 Adm_.alstrator,_.was really considering the question: ShouTd the drug be accepted
 ._._C_li_s_:__rathe_" than the question: Has. the drug been acce_ for
 ..... _ _edlcal use) By con_Iderlng little else but scientific test results and reports
 the Administrator _as _aking a dete_ination as to _hether or not_ in h_s opinion_
 _DMA ___L_ to be accepted ?or _edic_l _se in treat_ent_
 The Agency's arguments in the present case are to the sane e_cto Zn a
 word, they address the wrong questions It i_ not for this Agency to tell
 doctors whether they should or _hould not accept a drug or substance for _edica_
 use° °The statute directs the Administrator _erely to asce_a_n _hether_ _n
 facts doctors have done so,
 The MDMA third final order mistakenly looks to FDA criteria for g_idanc_ i_
 choosing criteria for DEA to apply, Under the Food, Drug _nd Cosmetic Act the
 FDA Is decidin.g _ properly, under that statute _ _hether a new drug should be
 introduced into interstate ¢o_erce. Thus it is appropriate for the FDA to rely
 heavily on test results and scientific inquiry to asce_ainwhether a drug is
 effective and _hether it is safe, The FDA _st look a_ a d_Jg and pass j_dge_
 _ent on _ts intrinsic quelit_es_ The DEA, on the other hand, is charged by 21
 Uo$_C, § 812(b)(1)(B) and (2)(B) _ith ascertaining _hat it is that other people
 have done _ith respect to a drug or substance: "Have they accep__ _t?_" _ot
 "_Should they accep.t it? _

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