KEN HARVEY. Formal response from the TGA

May 18, 2020

Dr Ken Harvey has provided the following formal response from the TGA as an update to his article (Pearls and Irritations, 7 May,

At a meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC) held on 14/05/2020, Adjunct Prof John Skerritt, Deputy Secretary, Department of Health explained why the TGA had dropped its investigation into Clive Palmer’s 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 Palmer’s 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 the TGA placed prescribing restrictions on the drug on 24 March 2020; only certain specialists can now prescribe hydroxychloroquine to new patients.
Dr Harvey reiterated his concern that inaccurate and misleading statements in the advertisements about hydroxychloroquine were likely to create false hope in the community and had placed pressure on medical practitioners to prescribe inappropriately.

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