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
suppose
[a
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
18
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