The TGA is seeking comments from interested parties on the proposed draft Therapeutic Goods Advertising Code 2018 (the Code) and associated guidance document. Comments should be submitted to the TGA by COB Friday 27 April.
Typically, many suggestions to improve the Code made by non-industry stakeholders in numerous previous consultations have been ignored.
The TGA’s strategy is to overwhelm stakeholders with numerous consultations in the hope of inducing confusion and submission fatigue. Then they tell Parliament they have extensively consulted stakeholders, but not that they have taken no notice of non-industry submissions!
For example, the Explanatory statement of the Therapeutic Goods (Permissible Indications) Determination No.1 of 2018 states,
“The draft list of indications was then published on the TGA website for public comment between July and October 2017. 110 submissions were received during that period from consumers (12 submissions) and industry stakeholders (98 submissions). Industry submissions primarily proposed additional indications for inclusion in the instrument, while consumer submissions expressed concerns about the terminology and evidence base for ‘traditional indications’ and contended that the number of indications in the instrument should be reduced. Stakeholder comments were considered, and the instrument was further refined to incorporate some improvements for greater clarity and in order to ensure that the list of indications is comprehensive and commensurate with the low risk nature of listed medicines”.
This contains nothing about numerous submissions from the RACGP, ASCEPT and others that argued that if consumers were to make an informed decision on ‘traditional” medicines an advisory statement was required along the lines of
“This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts” &/or “No scientific evidence has been provided that this product works”.
It did not mention public concern voiced by the RACGP President, “Alarming health claims must not appear on complementary medicine” and others, such as “New list of permitted advertising lines for complementary medicine products does little to protect consumers”.
Non-industry stakeholders have two remaining strategies to stop this craziness:
- Insist that the above advisories and other matters be added to the draft Therapeutic Goods Advertising Code 2018 (see notes).
- Write to Senators supporting the CHOICE campaign to disallow the Therapeutic Goods (Permissible Indications) Determination until health professional and consumer concerns are considered (See Choice letter).