Dear Mr Mostyn

Thank you for your correspondence dated 1 November 2021 in which you make the following request under the Freedom of Information Act 1982 (FOI Act):

"I am requesting the information for the protocol regarding the termination of a medicine due to fatalities.

Specifically, does the TGA have documentation that defines the number of deaths, or suspected deaths, that is appropriate for a medicine to remain in the market? And what is the number of deaths, or suspected deaths, that is inappropriate for a medicine which would lead to the medicine being terminated?"

At the outset, I note that your request is not a valid request under the FOI Act. The purpose of the FOI Act is to provide access to reasonably identifiable documents held by the TGA. The TGA is not required to answer specific questions or provide links to documents or information in the public domain. Notwithstanding that I am not required under the FOI to assist you, I would like to provide some guidance on how to access and extract the publicly available information which is relevant to your request.

The appropriate action taken by the TGA in response to Adverse Event Reports will depend on an assessment of the circumstances. The TGA regulates medicines, including the COVID-19 vaccines, based on an assessment of risks against benefits. The risk-benefit approach assures consumers that the products they take are safe for their intended use, while still providing access to products that are essential to their health needs. More information can be found at https://www.tga.gov.au/how-tga-regulates.

Reporting of an adverse event and publication of an adverse event in the Database of Adverse Event Notifications (available on the TGA website at https://www.tga.gov.au/database-adverse-...) does not mean the event was related to the relevant medicine. There might be no relationship between the adverse event and the medicine - it may be a coincidence that the adverse event occurred when the medicine was taken, and the symptom may be related to an underlying illness or to other factors. Expert analysis and review of adverse event reports is needed to determine whether there may be a link between reported events and medicines. If you wish to see further information on the TGA's guide to adverse events reporting, you may wish to consider the following: https://www.tga.gov.au/adverse-event-rep....

The TGA analyses adverse event report data and reviews individual reports to identify possible safety issues for investigation. If these investigations confirm a safety signal, the TGA takes appropriate action. There is not a predefined number of adverse event reports that leads to removal of a product from the market, as the type of action depends on the nature of the safety issue identified, including its likelihood and severity and the potential to mitigate the risk (such as through patient selection or monitoring), and the impact of the safety issue on the balance of benefits and risks for the product.

A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation. The uniform recall procedure for therapeutic goods (UPTRG) is available here: https://www.tga.gov.au/publication/unifo.... This webpage sets out all the steps in the recall procedure and explains which party is responsible for each step.

As set out on the TGA website, recall actions vary on a case-by-case basis depending on the deficiency of the therapeutic good and the risk the deficiency poses to public health and safety. Recall actions are classified according to the potential risk posed to patients/consumers by the defective goods. The classifications are as follows:
* Class I - Most serious safety-related - recall action occurs when there is a reasonable probability that the use of, or exposure to, the deficient therapeutic good(s) will cause serious, permanent or long term adverse health consequences or death.
* Class II - Urgent safety-related - recall action occurs when the use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
* Class III - Lowest risk - recall action occurs when the use of, or exposure to, the deficient therapeutic good(s) is not likely to cause adverse health consequences and they are therefore not safety related.

All recalls actions undertaken since 1 July 2012 are contained and classified in the publicly searchable System for Australian Recall Actions (SARA), available here:
https://apps.tga.gov.au/PROD/SARA/arn-en.... If you wish to obtain information about a specific recall action, you can search the name of the responsible therapeutic good in the SARA . If you wish to see further information on Australian recalls actions, you may wish to consider viewing this site: https://www.tga.gov.au/about-australian-....

I trust that this information assists you. As the information you have requested is already publicly available, and as I have provided you with guidance on accessing it, I consider your query dated 1 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

From: Sam Mostyn <[FOI #8044 email]>
Sent: Monday, 1 November 2021 6:33 AM
To: FOI
Subject: Freedom of Information request - Termination of Medicine due to Deaths

REMINDER: Think before you click! This email originated from outside our organisation. Only click links or open attachments if you recognise the sender and know the content is safe.
Dear Therapeutic Goods Administration,

I am requesting the information for the protocol regarding the termination of a medicine due to fatalities.

Specifically, does the TGA have documentation that defines the number of deaths, or suspected deaths, that is appropriate for a medicine to remain in the market? And what is the number of deaths, or suspected deaths, that is inappropriate for a medicine which would lead to the medicine being terminated?

Yours faithfully,

Sam Mostyn

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