Decision documents relied upon in prohibiting GPs from prescribing ivermectin for covid-19
Dear Therapeutic Goods Administration,
I understand TGA's Mr John Skerrit recently prohibited GPs in Australia from prescribing ivermectin for covid-19.
Please provide the decision documents Mr Skerrit relied upon to justify his decision.
Yours faithfully,
Jaay-H
Good afternoon Jaay,
Thank you for your email below dated 6 November 2021 in which you make the following request under the Freedom of Information Act 1982 (FOI Act):
"I understand TGA's Mr John Skerrit recently prohibited GPs in Australia from prescribing ivermectin for covid-19. Please provide the decision documents Mr Skerrit relied upon to justify his decision."
I would like to advise you that the TGA has recently published several documents in response to a previous FOI request, which relates to the recent restrictions on prescribing ivermectin for COVID-19. These documents include the ACMS' Discussion Paper on ivermectin; and the 35th ACMS discussion paper (out of session), which were the "decision documents... relied upon" in the decision to restrict off-label prescription of ivermectin. To access these documents, please see the TGA’s Disclosure Log at https://www.tga.gov.au/foi-disclosure-log for documents released in response to FOI 3061 (FOI documents 1 - 2).
Further to the documents already published on the TGA Disclosure Log, I would also like to provide you with some publicly available information which is relevant to your request.
Ivermectin has not received regulatory approval in Australia for use as a COVID-19 treatment. If a sponsor holds the appropriate evidence for a medicine, they are welcome at any time to make an application to the TGA to register that medicine in Australia. However, the TGA cannot compel a sponsor to make an application nor approve a treatment in the absence of an application. To date, there is insufficient evidence to support the safe and effective use of ivermectin for the prevention or treatment of COVID-19. More robust, well-designed clinical trials are needed before it could be considered an appropriate treatment option. In addition, the National COVID-19 Clinical Evidence Task Force (the Task Force) have recommended against the use of ivermectin as a treatment for COVID-19. The Task Force consists of peak health professional bodies across Australia, whose members are providing clinical care to people with COVID-19. Further information is available from the TGA website: https://www.tga.gov.au/covid-19-treatmen... and from the Department of Health website: https://www.health.gov.au/news/health-al....
The TGA has also published information relating to the decision to limit off-label prescribing of ivermectin. In particular, the TGA has published detailed statements which outline the changes and the reasons for the decision in the Notice of an amendment to the current Poisons Standard under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989, available at: https://www.tga.gov.au/media-release/new... and https://www.tga.gov.au/scheduling-decisi....
A diverse portfolio of COVID-19 treatments are at various stages of development in Australia and internationally, with some in advanced clinical trials and some subject to emergency use authorisation overseas. Treatments are being developed for a variety of clinical scenarios, with particular focus on therapies that potentially reduce the risk of disease progression in ‘high-risk’ patients who have mild-moderate disease and are not yet hospitalised.
The TGA rigorously assesses any COVID-19 treatment for safety, quality and effectiveness before it can be registered for use in Australia. Any application for a COVID-19 treatment is treated with the greatest priority. Information regarding COVID-19 treatments, including those which are being evaluated or which have been assessed or provisionally approved by the TGA, is publicly available on our website at: https://www.tga.gov.au/covid-19/covid-19... and the links therein. Further information is also publicly available at the following links:
• https://www.tga.gov.au/covid-19-treatmen...
• https://www.tga.gov.au/covid-19-treatmen...
• https://www.tga.gov.au/covid-19-treatmen...
• https://www.tga.gov.au/covid-19-treatmen...
I trust that this information assists you. As I have provided you with publicly available information and information about how to access recently-published documents on the TGA disclosure log, I consider your request dated 6 November 2021 to be withdrawn.
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [email address]
PO Box 100, Woden ACT 2606, Australia
Web: www.tga.gov.au
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