Stimulated by an article in today’s “The Conversation” on Pharmacare Laboratories Ease-a-Cold (below), I decided to try the TGA’s new complaint system.As I mentioned in a comment on this article, this product has been the subject of a previous article in “The Conversation” in 2015: https://theconversation.com/dont-believe-the-hype-your-complementary-medicines-are-unlikely-to-deliver-52139.
It has also had six upheld complaints by the now abolished Therapeutic Goods Advertising Complaint Resolution Panel (CRP) from 2005 to 2016 and a recommendation to the Secretary from the CRP in 2017 for failure to withdraw misleading representations that the product had “been ‘clinically trialed’ in the sense of being demonstrated to have effects such as reducing the duration, impact on daily life, or severity of symptoms of a cold”. Typically, I could find no outcome of this recommendation to the Secretary (TGA) on the TGA web site.
In addition, there was a decision to withdraw advertising approval (in specified media only, not the internet) by the TGA on 11 Oct 2017, see: https://tga.gov.au/decision-withdraw-medicines-advertising-approval.
Regardless, this product continues to be advertised with claims that have been repeatedly judged to be misleading and deceptive.
Furthermore, Pharmacare Laboratories has the unenviable reputation of the having the most upheld complaints of any sponsor of complementary medicines over the 10-year life of the CRP.
However, upon submission of the attached complaint I received the following error message:
This is the same error I reported to the TGA when I tested their system on Thursday 17/05/2018. It’s a pity it remained when the system went live.
I submitted that this complaint should be assessed as “high priority” because the sponsor is recalcitrant, the product has had numerous upheld complaints and the varied advertising claims by the sponsor (and many others) continue to state or imply that that the product will shorten the duration and severity of a cold when it will not.
I alleged (repeated) breaches of the Therapeutic Goods Advertising Code 2017, sections 4(1)(b), 4(2)(a) and 4(2)(c). In addition, specific indications on ARTG Public Summary Documents are equally misleading and deceptive.
I asked for an immediate response from the TGA to me as to the priority allocated to this complaint, and subsequently, the measures taken by the TGA to achieve compliance and the outcome (for publication).
I am concerned that the recently enacted Therapeutic Goods Information (Outcomes of Advertising Complaints Investigations) Specification 2018 only states that,
“The following specified kinds of therapeutic goods information may be released by the Secretary to the public under subsection 61(5C) of the Act….”.
It remains to be seen what we get back from the TGA for the attached test complaint.