norml02 - Page 24

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 Contrary to petitioners _ assertions_ the Administrator has not
 I relied on a "hodge-podge" of regulations that are arbitrarily
 removed from the context of the comprehensive FDCA regulatory
 i schemes Rather, the Administrator has incorporated those
 portions of those regulations that are relevant to the DEArs
 l determination of whether a drug has an accepted medical use_
 I These parts of the FDCA regulations relate to the Administratoras
 evaluation of evidence of accepted medical use. The Controlled
 I Substances Act requires the Administrator to request a scientific
 and medical evaluation and recommendation from DHHS prior to
 I placing a substance in, or removing it from, the schedules. 21
 I U.S_C. 811(b) (1988) _ When making evaluations and
 recommendations pursuant to the statutes there is no reason to
 I that DHHS would evaluate "scientific evidence of
 drug's] pharmacological effect" or _'the state of current
 I scientific knowledge regarding the drug," see 21 U_SoC. 811(c)
 l (1988), without regard to the quality of the clinical
 investigations involving the drug merely because it is acting
 I outside the interstate marketing approval context° It would be
 just as unreasonable to expect the Administrator to adopt a
 I lesser standard when evaluating evidence relevant to the question
 of accepted medical use°
 Petitioners nevertheless ask the Administrator to look beyond
 the relevant federal standard in effect when the Controlled
 Substances Act became law and to adopt a standard based in
 medical malpractice law as developed in the state courts. See

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