norml02 - Page 22
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safe and effective" under subsections (p) (I) and (w) (i) are
commonly referred to as "human GRASE" and "animal GP_SEf"
respectively_ In Hynson, the Supreme Court agreed with the FDA's
position that, with respect to GRASE drugs_ "the hurdle of
'general recognition' of effectiveness requires at least
_substantial evidence' of effectiveness for approval of an NDA."
412 UoS. at 629.
Petitioners' suggestion that the use of standards fundamental
to competent scientific investigation should be restricted to the
FDCA context of preventing consumer fraud by regulating
interstate commerce is without merit° When the Controlled
Substances Act became laws the FDCA contained the only existing
federal standards relevant to the evaluation of a drug's
effectiveness. Petitioners cannot contest that proposed or
actual labels of drugs often claim that the drug has a particular
therapeutic effect° Although the FDCA does not itself contain
the phrase "accepted medical use," any drug purported to have a
particular therapeutic effect would necessarily be evaluated for
effectiveness in the context of its "use in the diagnosis_ cure,
mitigation, treatment or prevention of disease." See 2i U.S.C.
321(g) (I) (definition of "drug") (1988). Therefore˘ the
Administrator's conclusion that drugs not approved for interstate
shipment because they lack effectiveness are drugs '_rejected by
Congress for medical uses '_ is a reasonable interpretation of the
FDCA_ See Final Order If, 57 Fed° Rego at 10,503o
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