norml08 - Page 31
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.i!_'_':__
Element three of our eight-point test, namely_
"establishment of its effectiveness in humans through
scientifically 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 will have the intended
effect in treating a specific, recognized
disorder_
D. Acceptance B ualified Ex errs Is Required.
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°
Wei_er v_ _son Etco, 412 U.So 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 tc evaluate the safety
and effectiveness of drugs° 21 UoS.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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