norml09 - Page 28

Page 28 Previous , Next , Original Image
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° _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

Previous , Next , Return to Index