norml09 - Page 28
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drugs its known effectiveness, its known and potential
risks, the severity of the illness to be treated, and the
availability of alternative therapies° _ss & Cla_
Division of Rhodia_ Inc. vQ FDA_ 4_5 F.2d 975_ 993 (D_C.
Cir. 1974). To know the risks, there must be adequate
studies_ by all methods reasonably applicable, to show the
pharmacological and toxicological effects of the drug.
21 CFR 314.125(b) (2) o This includes animal studies and
clinical trials in large numbers of humans. 21 CFR 312.21o
The studies need not be well-controlled, but they must be
adequate. Edison PrL_nnaceuticals COo v. FDA, 600 F.2d S31
(D.Co Cir. 1979). Short term (acute) studies of a drug
intended to treat long-term (chronic) illnesses_ such as
glaucoma or MS_ are clearly inadequate. United States v_
Naremco Inc., 553 F.2d 1138_ 1143 (Sth Cir. 1977). The
second element of our eight-point test, namely, '_the
toxicology and pharmacology of the substance in animals, _'
should be clarified as follows:
There must be adequate pharmacological and
toxicological studies_ done by all methods
reasonably applicable_ on the basis of which it
could fairly and responsibly be concluded, by
experts qualified by scientific training and
experience to evaluate the safety and
effectiveness of drugs_ that the substance is safe
for treating a specificr recognized disorder.
It must be emphasized that while the existence of
adequate safety tests is a separate analytical question, the
ultimate determination of whether a drug is safe for a
specific _se is not a distinct issue. Safety and
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