Medicines Australia might need to amend its Code of Conduct given the TGA's interpretation of the laws it administers that it says permit the provision direct-to-consumer of information about PBS-listed brands of prescription medicines.
The regulator's administration of these laws has become increasingly confused.
In the past week, it has fined Australian biotechnology company Starpharma for the "unlawful advertising" of its anti-COVID-19 nasal spray Viraleze while at the same time giving the green light to the publication of resources that advertise by brand some PBS-listed medicines for the treatment of inflammatory bowel disease.
The fine imposed on Starpharma was multi-faceted, including the fact Viraleze is not yet approved for use in Australia. Yet the fine was also imposed because, according to the regulator, the company's promotion of the product "included a restricted representation claiming that Viraleze is an antiviral nasal spray that stops SARS-CoV-2, the virus that causes COVID-19."
According to the regulator's statement announcing the fine against Starpharma, "Any claims or references to preventing or treating a serious form of a disease, condition, ailment or defect are restricted representations.
"Under the Act, the use of restricted representations in advertisements for therapeutic goods is unlawful without the prior authorisation of the TGA. No relevant authorisation has been granted for the advertised claims in this case."
This action against the Australian company was consistent with the TGA's general approach to the application of the laws for advertising therapeutic interventions. The regulator tends to administer this law to a very high and consistent standard - almost punitive - presumably because it wants to maintain a deterrent.
Yet at the very same time the TGA was imposing this fine on Starpharma, it was defending its failure to act against the Targeted Therapies Alliance for its promotion of some brands of PBS-listed medicines for the treatment of inflammatory bowel disease. The resources published by the alliance do not delineate between forms of disease or identify all potential treatments, including biologic disease-modifying anti-rheumatic drugs (bDMARDs).
The alliance's resources clearly include "claims or references to preventing or treating a serious form of a disease, condition, ailment or defect" and they have not been authorised. Where are the sanctions?
Yet not only has the regulator failed to authorise the resources, but it also says it is not required for these resources targeting patients - the public - with brand name PBS-listed medicines and the disease they treat.
The TGA fined and publicly shamed Starpharma but has taken no action against the Targeted Therapies Alliance. Why?
The implications of its failure to act or impose actions - go forth and advertise
Starpharma might question the magnitude of its fine given the regulator's 'green light' for the Targeted Therapies Alliance.
The wider implication is the TGA's apparent support for some forms of direct-to-consumer advertising of prescription medicines.
The Medicines Australia Code of Conduct (Code) is written to reflect the requirements of the Therapeutic Goods Act 1989 (Act). The Code does not currently permit brand promotion to consumers of PBS-listed medicines.
However, given the regulator's position on the Targeted Therapies Alliance, it appears the law allows a company to issue a media release including information on and links to publicly accessible websites hosting material about a disease and their PBS-listed treatment.
Based on the TGA's responses to questions about the Targeted Therapies Alliance, this material can include the brand, its benefits and the disease it treats. The material will not need to delineate between forms of the disease or mention alternative treatments and it will not be considered advertising to the extent it will not need to be authorised.