norml09 - Page 35
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that scientific evidence supporting an NDA be published.
This stems from the fact that a consensus of experts outside
FDA is not required for NDA approval_ In contrast, most
courts have held that a drug cannot be considered GRASE
unless the supporting scientific evidence appears in the
published scientific and medical literature. Without
published studies, it would be difficult for the community
of experts outside FDA to develop an informed acceptance of
a drug for medical useo Coo_____s Inco v. FDA, 501 Fo2d
772, 786 (D.C. Cir. 1974).
Point four of the eight-point test focuses, in part, on
the '_general availability of info_nation regarding the
substance and its useo _' This should be clarified to read:
In the absence of NDA approvalp information
concerning the chemistry_ pharmacology, toxicology
and effectiveness of the substance must be
reported, published, or othe_¢ise widely
available, in sufficient detail to permit experts,
qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs, to
fairly and responsibly conclude the substance is
safe and effective for use in treating a specific,
recognized disorder.
F. General Availabilit of a Q__q__i_____rrelevanto
The second component of point four of the eight-point
test involves the _generai availability of the substance"
for use in treatment. The second component of point eight
focuses on 'ruse of the substance by a substantial segment of
the medical practitioners in the United Stateso _ These
elements justifiably concerned the Court of Appeals, leading
to the remand in this case°
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