norml08 - 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 approvaio in contrast, most
courts have held that a drug cannot be considered GRASE
unless the supporting scientific ew[dence 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 use° Coop_e_rLabs Inc. voFD__A, 501 F.2d
772, 786 (DoC. Cir. 1974) _
Point four of the eight-point test focuses, in part0 on
the "general availability of information regarding the
substance and its use." This should be clarified to read:
In the absence of NDA approvals information
concerning the chemistry, pharmacoiogy_ toxicology
and effectiveness of the substance must be
reported, published, or otherwise widely
avaiiable, 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 Availabilitv of a Drug Is Irrelevant.
The second component of point four of the eight-point
test .involves the _'general availability of the substance"
for use in treatment. The second component of point eight
focuses on "use of the substance by a substantial segment of
the medical practitioners in the United States." These
elements justifiably concerned the Court of Appeals_ leading
?' to the remand in this case°
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