Have your say - TGA interim decisions on scheduling of Meloxicam and Lidocaine

The AVA is making two submissions to appeal the TGA's interim decisions on the rescheduling of transmucosal meloxicam and lidocaine.

Two templates have been prepared so that you can also submit your comments directly to the TGA:

• Meloxicam 
• Lidocaine     

Submissions are due on Thursday 15 September 2022.

Background:

Meloxicam

The Therapeutic Goods Association (TGA) has made an interim decision to amend the scheduling of the following MELOXICAM product from S4 (prescription-only) to S6 (available over-the-counter):

“Meloxicam in oral transmucosal preparations containing 1 per cent or less meloxicam for pre-surgical treatment and pain management in livestock during routine animal husbandry procedures.” 

The AVA has previously opposed this rescheduling. Read our submission here. 

Lidocaine

The TGA have also made an interim decision to keep the new S5 scheduling of LIDOCAINE (lignocaine):

“...in injectable preparations containing 2 per cent or less of lidocaine when packaged in a container with a tamper resistant cartridge which can only be dispensed through a rubber ring applicator for tail docking and castration of lambs, or castration of calves.” 

This means it will also be available over-the-counter without prescription.

The AVA opposed this change from S4 to S5 when it occurred (read our submission here), and we applied to have the decision reversed.  However, the TGA's interim decision is to keep it as S5.

Summary

The rationale for both of the TGA decisions can be read here.

These are both very concerning decisions, given that for both drugs there are toxicity and animal welfare risks if used inappropriately. The AVA strongly supports the use of anaesthetics and analgesics for husbandry procedures, however we maintain that these drugs should remain prescription-only, so that their use is accompanied by veterinary advice and directions, to ensure best possible animal welfare outcomes.  

The AVA is making two more submissions to appeal both these interim decisions.  But we need your help. Please use the links provided to download a draft response and submit directly to the TGA.

The templates are only suggested responses – please add or delete anything you wish, including your own experiences if possible.

You can submit by filling in the form on the TGA consultation hub here: https://consultations.tga.gov.au/tga/march-interims-2022/

Suggested templates for your response:  Meloxicam and   Lidocaine

The AVA thanks members for their assistance.