norml02 - Page 25
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Pet. 31-32; ALZ 27-29° Such a standard would have virtually no
meaning if, as petitioners urge, it would require the
Administrator to overlook the absence of a scientific basis for
i acceptance by the medical community and to refrain from
scrutinizing the qualifications of those members of the medical
I community who proclaim a medical use for marijuana. The
Administrator's assessment that "the absence of reliable evidence
establishing marijuana_s chemistry, pharmacology_ toxicology and
effectiveness _' forecloses any legitimate conclusion that it has a
medical use, is consistent with the fundamentals of scientific
analysis. See Final Order !I, 57 Fed. Reg. at 10,507.
i When the parties in this case were last before this court, the
court ordered the Administrator to ensure that his interpretation
I of the statutory standard did not result in requirements that
were impossible for a drug to fulfill by virtue of its placement
I in Schedule Io On review of the record die now_ the
Administrator has resolved the court's concerns.
First, the Administrator has clarified that general
availability of a drug and its use by a substantial segment of
the medical population are irrelevant to the determination of
whether the drug has a currently accepted medical use. Although
these are characteristics of a drug the FDA determines to be
l
"generally recognized as safe and effect!re," they are not
prerequisite to all objective determinat_ons of a drug's
currently accepted medical use. As the Administrator observes,
approval of an NDA under the FDCCA does not and cannot reasonably
[ 19
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