The Therapeutic Goods Administration (TGA) Australia has opened a consultation on guidance regarding the use of boxed warnings used to highlight serious safety issues. The guidance outlines the objectives for introducing a boxed warning to a Product Information (PI) document, and provides advice on how and when to use a boxed warning. The aim is to ensure consistency across the prescription medicines regulatory framework.
Currently over 30 products sold in Australia have boxed warnings to alert readers of the PI to specific safety issues that have major public health implications. The boxes, which are found at the start of the PI, are separate from the section that lists adverse events linked to the product. TGA can request their inclusion in the PI, or sponsors can propose to add boxed warnings to products.
Products sold around the world have similar warnings applied to products, however there is a lack of harmonisation. Therefore, TGA has drafted the guidance to ensure sponsors understand their obligations in Australia, whilst explaining the rationale behind boxed warnings to prescribers.
The draft guidance allows TGA to request boxed warnings on the strength of data from independent sources and to apply them to all products within a certain class of medicines. Even if researchers are yet to fully show a causal link between the product and the adverse event, it may still require a boxed warning. The TGA is seeking feedback from consumers, healthcare professionals and industry on the proposals until the end of August 2018.
The draft guidance notes that TGA could propose warnings in response to a range of events, for example the identification of an adverse event that tips the risk-balance profile, either in all patients or a subpopulation, or evidence that a drug is far less effective in some patients than others.
Furthermore, the guidance describes the content and format of boxed warnings. TGA states that boxed warnings should provide a concise statement that directs the prescriber to a more detailed discussion of the safety risk contained elsewhere in the PI.
To read TGA’s public consultation paper on boxed warning guidance, please click here.