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Believe it or not, I got a reply from an email I sent to our local (Australian) TGA or Therapeutic Goods Administration which is the equivalent outfit to US’s FDA. I complained to them that their website was wrong in that it stated that “there was no effective treatment currently known to help people with COVID-19”.
Amongst all they responded with was this eye-opening bit: “The TGA would welcome an application to register ivermectin for the treatment of COVID-19 at any time; however, the TGA cannot compel a company to make such an application”
For the full context see way below:
My complaint was as here:
<b style=”font-family: inherit;”>Report of a perceived breach of the Therapeutic Goods Act or questionable practices relating to therapeutic products
Submitted on Thursday, March 25, 2021 – 10:15pm
Contact details
Reporter’s name: MR PETER F BELL
Reporter’s email: [email protected]
Reporter’s telephone number: 0408623598
Reporter’s mobile phone number: 0408623598
Reporter’s fax number:Details of problem
Date problem was encountered: Thu, 12/03/2020
Name of product of concern: ivermectin information
AUST R or AUST L number on product label, if known: N/A
Name of company/person supplying the product: TGA
Address of company/person, if known: Their place
Contact details of company/person, if known (telephone, fax website, etc.): You KNOW this
Details of problem – please be as specific as possible:TGA consistently advertise on their website that there is no medicine that controls COVID-19.
This is wrong.
Ivermectin has proved to be very effective prophylactically, early treatment and excellent at controlling or suppressing cytoplasm storm.Dear Mr Bell
Thank you for contacting the Australian Government Department of Health.
In order to provide you with an appropriate response I need to provide you some background information as to therapeutic goods regulation in Australia.
Australia has a robust regulatory process for prescription medicines administered by the Therapeutic Goods Administration (TGA), part of the Department of Health. For ivermectin to be registered on the Australian Register of Therapeutic Goods (ARTG) by the TGA to treat COVID-19, a sponsor (usually a pharmaceutical company) is required to submit a comprehensive developmental dossier application for the medicine. This dossier usually consists of clinical studies, non-clinical/toxicology studies, and other information. Once accepted by the TGA, a formal evaluation of the application is undertaken in multiple stages by technical experts.
The process involves obtaining further information and clarification from the sponsor, and may also include seeking advice from an independent committee of external experts prior to finalisation and decision under the Therapeutic Goods Act 1989. Decisions are based on whether the overall benefit of the medicine is considered to outweigh the potential risks of its use. If a decision is made to approve the medicine, it is included on the ARTG and can be lawfully supplied in Australia for the intended use.
The TGA would welcome an application to register ivermectin for the treatment of COVID-19 at any time; however, the TGA cannot compel a company to make such an application. Priority and provisional evaluation pathways are available depending on the nature of the application and the supporting data.
Ivermectin has not received regulatory approval in Australia or anywhere overseas for the treatment or prevention of COVID-19. More robust evidence is required before it could be considered a safe and effective treatment option.
The National COVID-19 Clinical Evidence Taskforce, consisting of a large group of independent Australian clinical experts, is continuously updating treatment recommendations based on the best available evidence. They are currently not recommending the use of ivermectin for COVID-19 treatment outside of properly conducted clinical trials with appropriate ethical approval. The living guidelines are available online at: http://www.covid19evidence.net.au.
Yours sincerely
Regulatory Assistance Service
Regulatory Guidance, Assistance and SME SectionRegulatory Engagement, Education and Planning Branch
Phone: 1800 020 653 Fax: 02 6203 1605
Email: [email protected]Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia