norml09 - Page 31

 Element three of our eight-point test, namely,
 _'establishment of its effectiveness in humans through
 sc±entifically designed clinical trials, _ should be restated
 as:
 There must be adequate_ well-controlled, well-
 designed, well-conducted and well-documented
 studies, including clinical investigations, by
 experts qualified by scientific training and
 experience to evaluate the safety and
 effectiveness of drugs_ on the basis of which it
 could fairly and responsibly be concluded by such
 experts that the substance wiil have the intended
 effect in treating a specific, recognized
 disorder.
 D. Accep_____qe___Qualified Exer_Is Requ_redo
 The opinions of lay persons are totally irrelevant to
 whether a drug is GRASE or meets NDA requirements. The
 observations and opinions of medical practitioners who are
 not experts in evaluating drugs also are irrelevant to
 whether a drug is GRASE or meets NDA requirements.
 Weinberqer Vo H nson Etc._ 412 U.S. 609_ 619 (1973). By
 explicit requirements in the FDCA since 1938_ the only body
 of opinion that counts is that of experts qualified by
 scientific training and experience to evaluate the safety
 and effectiveness of drugs. 21 U.S.C. 321(p) and (w) _
 From this, one would conclude that expert acceptance of
 a drug as safe and effective for its intended use is
 essential to a drug having a currently accepted medical use
 under the CSA. How widespread must this expert acceptance
 be?
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