In August 2012, CRI made a detailed submission to the TGA Medicine Labelling and packaging review.. The TGA has successfully ignored all of our detailed comments and recommendations.
Even though, following our comments, they gave two undertakings to:
- provide evidence that particular changes will improve medicine safety and the quality use of medicines
- undertake independent consumer testing of proposed options.
There is no mention of either of these in the draft regulations or guidelines.
In my final remarks I do not comment on the detail of the proposed regulations. To do so would be akin to offering to rearrange the deck chairs on the Titanic.
TGA describes this as best practice!
My single comment on the proposed TGA79 itself is that it should be held over until the expert committee recently appointed by government to review the TGA has completed its work.
My remarks focus on the likely outcomes from adopting these regulations. This is a sad day for Australia’s well regarded policy of Quality Use of Medicine.
For those of you who have been following our remarks and reports on the TGA proposed TGOI79, you can download my final comments by clicking here.