norml02 - Page 20
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i one schedule to another. See 21 U_S°C. 81!(c) (2) , (3) (1988).
l Insofar as these factors relate to the determinative finding of
whether or not a drug has a _'currently accepted medical use," the
I Administrator's consideration of information relevant to the
FDA's determination of a drug's safety and efficacy is
I undoubtedly reasonable. Both statutes call upon the government
to determine what purpose a given drug is supposed to serve and
whether the drug truly serves that purpose°
l Since the FDA has refused to applications to
1962,
approve
introduce new drugs into interstate commerce (New Drug
Application or NDA) when _there is a lack of substantial evidence
i that the drug will have the effect it purports or is represented
to have _' according to its proposed labeling° See Drug Amendments
of 1962, tit. i_ § i02(c) _ 76 Stato 780_ 781 (1962) (current
version at 21 U.S.C. 355(d) (1988)). Substantial evidence
sufficient to support approval of the application consists of:
adequate and well-controlled inw_stigations_ including
clinical investigations_ by expe:[ts qualified by
scientific training and experience to evaluate the
effectiveness of the drug involved_ on the basis of which
it could fairly and responsibly be concluded by such
experts that the drug will have =he effect it purports or
is represented to have [according to its proposed
labeling].
21 U.SoCo 355(d) (1988). The implementing regulations enumerate
that "have been developed over a period of years
characteristics
and are recognized by the scientific community as the essentials
I of an adequate and well-controlled clinical investigation." See
21 C.F.Ro 314.126. _he controls and other characteristics listed
support the investigationai objective of _'distinguishing the
I 14
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