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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. 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

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