The recent decision by the Therapeutic Goods Administration (TGA) to drop its investigation into advertisements for hydroxychloroquine splashed over 3 pages of national newspapers by Clive Palmer is the latest example of its regulatory failure.
The reported excuse from the TGA that, ‘The information was assessed as not intended to promote the sale of the product’ is not only wrong but dangerous.
I have asked the TGA to provide an explanation as to why this matter was not pursued.
‘Advertise’ is defined in the Therapeutic Goods Act 1989 as, ‘any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods…’. In addition, prescription medicines are prohibited from being directly advertised to the public.
The following statements were made on the first page of Palmer’s 3-page advertisement, ‘hydroxychloroquine was the best hope for those suffering COVID-19’ and ‘the best treatment for its citizens should the worst occur’ and ‘it was critical that the drug remained available in hospitals for those who needed it to treat COVID-19’.
In my opinion, these unbalanced, misleading and unscientific statements clearly promote the use of this medication.
In addition, the 2nd and 3rd page of Palmer’s advertisement, ‘COVID-19 Response and Action’ rely selectively on a discredited French study, fail to mention negative trials and omit mention of serious adverse events. Current Australian and overseas recommendations do not support the use of hydroxychloroquine for COVID-19.
Until ongoing clinical trials have been peer-reviewed, published and replicated, it is unethical and dangerous to promote the use of this medication. Not only does this create false hope among the public, but it also pressures medical practitioners to prescribe inappropriately.
The TGA has apparently chosen to ignore or misinterpret the long-standing definition of advertising. It appears the TGA thinks it means ‘sale’, which is clearly not in accord with the definition in the Therapeutic Goods Act.
I have asked the TGA to explain why it has not conducted a full investigation into this matter and why the penalties available under the law for such advertising have not been instituted (s.21B of the Act).
Disregard of the Palmer advertisement is an encouragement for businesses to game the regulatory framework by expressing harmful information without consequence because the promotional statement does not directly solicit a sale.