The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia

OBJECTIVE: To review the sequence of events that led to the Therapeutic Goods Administration (TGA) approval of esketamine in Australia, and to explore the potential ethical and clinical consequences of it. CONCLUSIONS: Trust in the TGA is of paramount importance to Australian psychiatrists. The approval of esketamine raises serious questions about the processes, independence and authority of the TGA, and therefore the confidence Australian psychiatrists can have in the ‘quality, safety and efficacy’ of the drugs they offer their patients.