Following our blog late last year (Truth in Advertising of Devices and Drugs in Australia – TGA to in-source controls, remove pre-clearances) on the recommended changes to the Therapeutic Goods Advertising framework, TGA has posted a consultation period up until April 27 for interested parties to comment on the draft Therapeutic Goods Advertising Code 2018 (the Code) and associated guidance documents.
The Advertising Code and guidance documents have been drafted following the previous consultations conducted by TGA in 2017 and the recommendations made during the 2014 Expert Panel Review. Included in the published documents is a Comparison between Therapeutic Goods Advertising Code 2015 and the proposed 2018 Code which will assist companies come up to speed with the necessary changes being implemented.
The new draft includes some important changes arising from review recommendations. In particular there are a numbewr of completely new or substantially clarified requirements:
- A new explicit requirement at 10 (a) (i) that all advertising must present the goods in accordance with instructions for use. This explicit requirement will make it easier for TGA to police misleading claims and off-label promotion.
- Advertising for medicines must include references/links to sources of further information including warnings, precautions and adverse effects.
- Clarification of the requirements around testimonials including specifying acceptable forms and sources and stricter requirements to disclose paraphrasing, truncation or other editorial changes in testimonials.
- Advertising of goods with a history of causing a serious allergic reaction in particular patient groups must contain a prominent warning applicable to the affected patients.
- Advertising must not conflict with contemporaneous government public health campaigns.
- New requirements which reinforce the public health messages around appropriate use of sunscreens as one part of sun protection (slip, slop, slap revisited!)
- Removal of the old list of disease types which were restricted representations (requiring TGA consent to advertise) and reliance on a broader definition of “Serious condition”. This approach brings some welcome flexibility – including the explicit inclusion of the option of making qualified claims so that the advertising does not fall within the scope of restricted representations. But it’s a double edged sword. The drafting in the new code places the onus squarely on the advertiser to justify that they are not making a restricted representation.
- A new provision for TGA to waive prohibited representations in certain circumstances (this is a new provision at Section 42DK of the latest revision of the Therapeutic Goods Act).
Once the TGA has considered feedback from this consultation and from the Therapeutic Goods Advertising Code Council (TGACC), final amendments will be made to the proposed draft Code and guidance document. At this stage it is anticipated the new Code will come into effect from 1 July 2018.
If you are considering submitting a response to these documents, or just need assistance in meeting your advertising requirements, contact us to discuss!
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