Following a Parliamentary review into the transparency of the Therapeutic Goods Administration (TGA), the TGA has initiated its own review into the labelling and packaging framework for all prescription, over-the-counter and complementary medicines. Although the TGA review will examine all packaging and labelling for medicines, a major concern will be the lack of regulation of the use of nanoparticles in both the drug delivery and medical imagery fields.
In June 2011, the TGA released the Review to improve the transparency of the Therapeutic Goods Administration (Review). The purpose of the Review was to investigate the perception that the TGA does not provide the public with sufficient information about its activities and the goods that it regulates. The review panel was created by Parliamentary Secretary for Health and Ageing Catherine King and chaired by DLA Piper Special Counsel Professor Dennis Pearce. In the panel's final report 21 recommendations were made, designed to enhance the TGA's transparency. A key recommendation made by the panel was to improve the labelling and packaging requirements of therapeutic goods.
The recommendation was made after the review panel discovered deficiencies in the current labelling regime. The review panel noted that irregularities, inconsistencies and a general lack of information were being provided under the TGA labelling requirements. Of particular concern was the apparent lack of regulation around the labelling of nanoparticles on medical packaging. At present, there are no requirements to include a statement that a product includes nanoparticles. This is of particular concern given their increasing use in the drug delivery and medical imagery fields.
The Review recommended the TGA improve labelling and packaging requirements to educate and assist both customers and health practitioners in making informed decisions about the quality of therapeutic goods. As at the date of publication, the Commonwealth Government had not yet agreed to adopt this or other recommendations made by the Review.
As a direct result of the Review, the TGA began its own consideration in early August into how goods are labelled and packaged (TGA review). The purpose of the TGA review is to examine how medicines are labeled and packaged; thereby assisting consumers and healthcare practitioners to make informed decisions about the quality use of therapeutic goods. In particular, the TGA review seeks to address three specific concerns from the Parliamentary Review:
- the inaccessibility of mandatory information on the particular medicine
- the inconsistency of the positioning and font size for important information
- the lack of information about non-active ingredients.
The TGA review is expected to be released in October, though it is subject to the Commonwealth Government accepting the recommendations put forth in the original Review. Ewen Hollingsworth
TGA to consider further advertising transparency measures
The TGA policy to publish its investigations into alleged breaches of its advertising code is designed to provide advertisers guidance on how the TGA interprets advertising requirements. So far two complaints for breaching the advertising code have been published; a complaint into Invisible Zinc's claim other sunscreens were harmful and Hedrin Lotion's claim that it did not contain pesticides. However, following a parliamentary review the TGA is considering revamping these transparency measures to deter sponsors from breaching advertising requirements set out in the Therapeutic Goods Advertising Code.
The advertising of therapeutic goods to consumers is regulated by, among other things, the Therapeutic Goods Advertising Code (Advertising Code). Compliance with the Advertising Code is monitored by the TGA Complaints Resolution Panel (Panel), whose purpose it is to investigate complaints regarding advertisement breaches of the Code. If the Panel determines the complaint is justified they may request that the sponsor do certain things such as withdraw the advertisement or publish a corrective statement.
If sponsors fail to adhere to the Panel's requests the complaint may be referred to the TGA. From there the TGA may initiate its own investigation and take certain action, including publishing the complaint. Prior to the parliamentary review to improve the transparency of the TGA (see TGA Review of Labelling and Packaging article) the TGA was reluctant to publish complaints.
Following the parliamentary Review, this position has subsequently changed and have already published the complaints concerning Invisible Zinc and Hedrin Lotion . The fact that the TGA has published these two complaints indicates the TGA has become increasingly willing to 'name and shame' sponsors in order prevent breaches of the Advertising Code.
As a result of the parliamentary review, the TGA has decided to review its current advertising transparency measures. The TGA's current advertising measures are designed to protect public health by promoting the safe use of therapeutic goods and ensuring that they are honestly promoted as to their benefits, uses and effects.
Little detail has been given regarding the proposed review or changes by the TGA and when they may come into effect. Despite the vagaries of how the TGA may amend their advertising transparency measures, sponsors should be hesitant not to comply with any request from the Panel. Failure to comply may see further action taken by the TGA, including publication of the investigation.
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