The parable of the Therapeutic Goods Administration approval of esketamine (Spravato) in Australia.
William Lugg
Australasian Psychiatry April 2023 DOI: 10.1177/10398562231156475 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Commentary Peer reviewed |
|---|---|
| Topics | Esketamine Ketamine |
| Keywords | Janssen-cilag Therapeutic goods administration |
| Key points | Argues that the TGA's approval of esketamine in Australia raises serious questions about the agency's processes, independence, and authority, and therefore about the confidence Australian psychiatrists can have in the 'quality, safety and efficacy' of the drugs they offer patients. Trust in the TGA is described as being of paramount importance to Australian psychiatrists. |
Abstract
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. 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.