Review of restrictive actions under the Australian drug regulatory system.

Abstract

An analysis of restrictive measures taken by the Australian Drug Evaluation Committee (ADEC) over the period of 27 months (from March, 1976, to June, 1978) was made by two non-Australian observers. During this period, the ADEC took 32 useful restrictive measures (a little more than one a month). The analysis was limited only to cases in which ADEC took substantial action; if less comprehensive measures were included, the number of valid actions to counter the occurrence of iatrogenic complications would be much greater. It is concluded that, although it is an undisputed fact that many pharmaceutical companies maintain the highest ethical standards, there is a need for the type of objective and dispassionate control exercised by the Australian Drug Evaluation Committee.