norml08 - Page 28
Return to Index
drugs its known effectiveness_ its known and potential
risks_ the severity of the illness to be treated, and the
availability of alternative therapies. Hess & Clark
Division of Rhodia_ inca v. FDA, 495 F.2d 975_ 993 (DoC.
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 312.21.
The studies need not be well-controlled, but they must be
ade_date. Edison Pharmaceuticals Coo vo FDA, 600 F_2d 831
(DoC. Ciro 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. s 553 F.2d 1!38_ 1143 (Sth Ciro 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 specifics recognized disorders
It must be emphasized that while the existence of
adequate safety tests is a separate analytical questions the
ultimate determination of whether a drug is safe for a
specific use is not a distinct issues Safety and
Return to Index