vol1 - Page 310

 its initial brief, theAlllance asserts this position is
 incorrect.
 If. LEGAL ANALYSIS
 In_/t_nsDoon v. D/ua2_Ifg/ce_l__A__in_stration, the
 First Circuits resoundingly rejected DEA_s reliance upon FDA's
 IND/NDA efficacy procedures for defining Uaccepted medical use ix
 treatment_in the United States_ # The Court declared:
 #[n3owhere does Congress equate Ssafety and
 efficacy _ under the FDCA with _he second and
 third Schedule X criteria contained in
 § 812(b)(I). This_ indeed, is the point at
 ..... issue in this iit±gation_ and we are loathe
 to accemt such a disinaenuous argument. ;!q
 In direct contravention of thins stern language, DEA
 simply readopts this IND/NDA-based efficacy standard in its
 February 22_ 1988 Order. _/ Even a cttrso:ry review of°DFEA_s
 ruling makes this fact explicitly clear. _/ In its brief, filed
 in this proceeding, DEA acknowledges that it is simply adopting
 the #safety and efficacy" requirements of the rejected NDA
 procedure; _the Administrator of DEA has limited the standards
 for accepted medical use and accepted safety to those matters
 i/ 828 F.2d at 888 (emphasis added).
 I/ 53 Fed. Reg_ 5156 (1988).
 _/ I_o at 5157-58. DEA reincorporated all aspects of the
 October 148 1986 Order in the MDMA proceeding with the exception
 of those paragraphs that explicitly stated the need for NDA
 approval as a prerequisite for a finding of _accepted medical us_
 in treatment in the United States. _ 51 [Fed. Rego 36554-55
 (Oct. 14, 1986).