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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