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 #efficacyobased n prong of the DEA test is unquestionably invalid
 and w_ll not withstand even the slightes_ judicial scrutiny_
 Not satisfied with defining naccepted medical use in
 treatment # solely based on efficacy, the DEA then fabricates
 statutory language that simply does not exists Throughout its
 brief, the_-Agency alleges that to be placed in Schedule II a drug _
 must hav__ Naccepted safety _ _ _ under medical supervision, nl_/
 DEA fails, however_ to attribute this language to the Control
 Substances Act _- and with good reason. Congress did not include
 safety as a prerequisite for Schedule II classification° In
 order to be placed in Schedule II_ a drug must have a Ncurrently
 accepted medical use in treatment in the United States. #16/ As
 the Alliance demonstrates in its initial brief, once a drug is
 shown to have an naccepted medical use in treatment _ it is then
 incumbent-upon the Agency to show that the drug is _unsafe° "I//
 Ignoring this obvious flaw in its arguments DEA
 develops a _safety u standard which is more stringent than the
 safety requirement in FDA's new drug approval procedure. Again,
 as discussed_ ___P_T__ this standard is directly contrary to the
 letter and spirit of the _ decision _= i oeo s that it is
 15/ DEA Brief, passim°
 i_6/ 21 U°S.C. § 812(b)(2)_ The parties stipulated that the
 other statutory prerequisites for Schedule II -- high potential
 for abuse and the likelihood of psychological dependence -- are
 not relevant in this case° See Order of the Administrative Law
 Judge, March 2, 1987_
 17/ Grinspoon v. DEA, 828 F.2d at 887. _ee also DEA Brief at
 94-95.




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