The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued seven infringement notices totalling $93,240 to Melbourne-based global biopharmaceutical company Starpharma Holdings Limited (Starpharma), for alleged illegal advertising of a nasal spray that is not approved for use in Australia.
Starpharma allegedly promoted, on two of the company's websites and its YouTube channel, the use and supply in Australia of a nasal spray called Viraleze that was not entered on the Australian Register of Therapeutic Goods (ARTG).
The Therapeutic Goods Act 1989 (the Act) prohibits advertising to the public for therapeutic goods that are not entered on the ARTG (unless a specific exemption, approval or authority applies).
The alleged advertising, on two of Starpharma's websites, included a restricted representation claiming that Viraleze is an antiviral nasal spray that stops SARS-CoV-2, the virus that causes COVID-19. 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.
The advertising, on the company's two websites, allegedly referred to the substance Astodrimer sodium that is included in Schedule 3 (Pharmacist Only Medicine) of the current Poisons Standard. The reference to Astodrimer sodium in relation to SARS-CoV-2 is not permitted in advertising to consumers and was not authorised or required by a government or government authority.
Consumer directed advertising must not include any reference to a substance included in Schedule 3 of the Poisons Standard, unless the substance is also listed in Appendix H of the Poisons Standard for the permitted indication (specific therapeutic use).
Warning to advertisers
All advertisers are responsible for ensuring their therapeutic goods advertising is compliant. Therapeutic goods advertising to consumers must comply with all applicable requirements in the Act. This includes the requirement to comply with the Therapeutic Goods Advertising Code.
If you need regulatory assistance regarding your specific circumstances we encourage you to seek independent legal advice or the assistance of a regulatory affairs consultant. The TGA does not endorse consultants, however we maintain a list of industry organisations that may be able to help you find one.
Educational information and resources about Australia's advertising rules for therapeutic goods can be found on the TGA website.
The TGA has published a warning to advertisers and consumers about illegal advertising relating to COVID-19.
The TGA takes action against breaches of the Act
The regulatory scheme is critical to the health and safety of Australian consumers and the TGA investigates suspected unlawful activity in relation to therapeutic goods.
The TGA reminds advertisers that sanctions and penalties can apply if they advertise therapeutic goods in a way that does not comply with Australia's advertising laws. The range of compliance and enforcement tools available include substantial fines and criminal or civil court action.
