By Peter Roberts
I have nothing but the deepest respect for Australia’s Therapeutic Goods Administration, but a certain lack of initiative on the part of the TGA seems to be preventing Australians from getting access to the latest Australian-developed tools to fight Covid-19.
Make no mistake the TGA has an exemplary record in regulating Australians’ access to drug treatments and medical devices, but one can’t help think that a little bit of proactivity on the part of the TGA wouldn’t go amiss, especially in the middle of a pandemic.
We already have heard of concerns around the registration of rapid antigen tests by a number of Australian manufacturers such as Queensland’s Ellume.
These tests have been registared and in use overseas, but despite being made here the TGA has taken a very passive attitude to getting them onto local markets.
While the TGA questions the companies for more information and so on, it never seems to grab a real opportunity to meet a real and urgent need and pursue these registrations.
The latest incidence of this bureaucratic style was revealed in Channel 9 media today over the lack of progress registering Starpharma’s Viraleze anti-viral nasal spray.
The TGA told The Age and The Sydney Morning Herald that it had received an application from Starpharma for the product, but the regulator believes the company has applied for the wrong therapeutic goods category.
A TGA spokeswoman said: “The TGA has discussed the differences between a medicine and medical device with Starpharma verbally and in writing on several occasions, as recently as mid-January 2022.
“To date, Starpharma has not sought advice from the medicines authorisation branch of the TGA nor have they submitted an application for this product to be included in the [register] as a medicine.”
@AuManufacturing approached Starpharma CEO Dr Jackie Fairley but at the time of publication had not received a response.
Apparently Dr Fairley is bewildered by the TGA’s attitude as the Mundicare Cold Defense Nasal Spray, Flo Travel Nasal Spray and Vicks First Defence Nasal Spray are already registered as medical devices.
Now no-one expects the government to do a company’s work for it, but perhaps in the middle of a pandemic which right now is killing a disturbing number of old people and children the TGA, or someone in the government of health department, might actively seek to get this useful medication on the market as soon as possible?
This was underlined with an announcement from Starpharma this morning that the Viraleze nasal spray has been shown in a new study to reduce the Omicron variant of the SARS-CoV-2 virus by greater than 99.5 per cent.
The study by the Scripps Research Institute found: “(It) has shown potent antiviral activity and was viricidal against the Omicron variant.”
It has been obvious for months that Viraleze has anti-viral properties and previous research has shown it effective against Delta, Alpha, Beta, Gamma and Kappa variants.
Clearly it would be most useful in hospitals where staff could use the spray each time they treat an infected patient and as they remove their PPE.
Dealing by email in a business a usual manner is no substitute for the authorities, TGA included, in picking up the phone when something so glaringly useful – and locally made – comes to light and just getting it sorted.
Subscribe to our free @AuManufacturing newsletter here.