Dr Ken Harvey has provided the following formal response from the TGA as an update to his article (Pearls and Irritations, 7 May, https://publish.pearlsandirritations.com/ken-harvey-tga-fails-to-act-on-palmers-hydroxychloroquine-advertisements/)

At a meeting of theTherapeutic Goods Advertising Consultative Committee(TGACC) held on 14/05/2020,Adjunct Prof John Skerritt, Deputy Secretary, Department of Health explained why the TGA haddropped its investigation into Clive Palmers 3-page hydroxychloroquine advertisements that ran in major Australian newspapers from April 28 to May 2, 2020.

Prof Skerritt said, Taken as a whole, the TGA felt the advertisements primarily promoted Mr Palmers efforts in donating hydroxychloroquine rather than hydroxychloroquine itself. The TGA accepted this was a line-ball decision. A key factor for TGA was that the product was going into the national medical stockpile and could only be released for clinical trials or use by doctors on the decision of the Chief Medical Officer or Deputy Chief Medical Officer. It noted the wording about the drug in the advertisement reflected careful legal crafting.

In response to reports of inappropriate off-label prescribing of hydroxychloroquine theTGA placed prescribing restrictions on the drugon 24 March 2020; only certain specialists can now prescribe hydroxychloroquine to new patients.

Dr Harvey reiterated his concern thatinaccurate and misleadingstatements in the advertisements about hydroxychloroquine were likely tocreate false hope in the community and had placed pressure on medical practitioners to prescribe inappropriately.