vol1 - Page 318
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indications. 21/ Likewise, a sufficient body of evidence exists
demonstrating that marijuana has a _ourrently accepted medical
use with severe restrictions_ n for the treatment of spasticity.
C%Iriously_ the government makes little or no effort to refute
this consistent body of evidence demonstrating the drugSs medical
utility.
Indeed, so ove_helming is the evidence presented in
this case that Dr. Denis Petro, a former FDA consulting review
officer for NDAs and INDs, concluded that marijuana could easily
satisfy the NDA requirements. 2_/ The evidence of marijuana_s
medical utility and safety overwhelmingly prove Dr. Petro is
correct. These matters will be discussed in greater details
21/ In its brief, DEA concedes that only _substantial evidence _
is necessary to prove that marijuana satisfies the requirements
of a Schedule II druga DEA Brief at 90-91 (citing American
Textile Mfgrs. Institute v. Donovan, 452 UoS. 449_ 522o23
(1981)) o To the extent that DEA is acknowledging the traditional
aam_inistrative definition of ns_Ibstantial evidence _ is the
appropriate burden of proof, the Alliance has easily satisfied
this evidentiary burden_ Given the overwhelming magnitude of
evidence demonstrating maccepted medical uses H the Alliance has
satisfied any standard of proof that may be adopted by the
....... Administrator for purposes of this proceeding. There is nothing
in the Controlled Substances Act to indicate that Usubstantial
evidence, _ as defined by DEA in this proceeding is in any way
similar to the #substantial evidence # test of 21 U.S.C. § 355(d) o
Again, however, the Alliance believes that the evidence of
marijuanats #accepted medical use a plainly could satisfy this
standard as well_
_2_/ Affidavit of Denis Petro, _ 77.
23/ If the Alliance has any obligation to demonstrate that
marijuana is safe for use under medical supervision, the evidence
as discussed in Sections XlX and IV_ _!_, overwhelmingly
satisfy this burden°
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