norml02 - Page 22

Page 22 Previous , Next , Original Image
Return to Index

 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

Previous , Next , Return to Index