vol1 - Page 315
Page 315
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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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