Letters to the Editor
Critical appraisal: court in the Act
- Brian Richards
- Aust Prescr 2012;35:75-7
- 1 June 2012
- DOI: 10.18773/austprescr.2012.033
Editor, – The Therapeutic Goods Administration (TGA) wishes to ensure that readers of your recent editorial (Aust Prescr 2012;35:38-9) are not left with the misapprehension that they place themselves at legal risk by reporting concerns about a therapeutic good to the TGA. Your editorial failed to acknowledge that personal information relating to complaints made to the TGA is regarded as confidential and that neither the TGA, nor the Complaints Resolution Panel, publishes information that identifies a complainant. In the instance that you cite in your editorial, it was only after a third party published the complaint (and the identity of the complainant) on the internet that the company initiated legal action against Dr Harvey.
The TGA is particularly concerned to ensure that readers do not infer from your editorial that legal action taken by a company about the advertising of its product has implications for healthcare professionals who report suspected adverse events to the TGA.
Health professionals play an important role in ensuring the safe use of therapeutic goods by reporting both adverse events and advertising breaches to the TGA. These reports are essential to the role of the TGA in safeguarding the health of all Australians who use therapeutic goods.
Your editorial further comments that the TGA’s strategy of silence and secrecy gave the appearance we were doing nothing in respect of the alleged advertising breach. Although the TGA operates within a statutory framework and needs to ensure that proper procedures are followed when taking regulatory action, your editorial should have noted that a number of reforms announced by the Parliamentary Secretary for Health and Ageing in December 2011 are being implemented to address this concern.
National Manager (acting)
Therapeutic Goods Administration
National Manager (acting), Therapeutic Goods Administration Canberra