Therapeutic Goods Administration Approvals for Australian Defence Force Use of Tafenoquine in Clinical Trials, 1999-2000
Dear Therapeutic Goods Administration,
This follows a previous request to the Therapeutic Goods Administration seeking documents relating to TGA approval/s for the Department of Defence to administer Australian Defence Force (ADF) personnel with the unregistered anti-malarial drug tafenoquine in a series of clinical trials during the period 1998-2002.* Research into publicly available documents relating to those trials revealed that Defence conducted at least two additional trials with results that were not published in academic journals:
a. 1999, "maritime operators", unknown location/s - at least 148 subjects.
b. February 2000, members of the 3 RAR battalion group, Timor Leste - 406 subjects.
I hereby request the TGA to provide documents relating to any approvals for the ADF or Department of Defence to administer tafenoquine to ADF personnel during the above clinical trials, including but not limited to:
a. Requests from ADF or Defence officials for TGA approval to use tafenoquine.
b. Minutes of meetings, records of conversations, or other correspondence between TGA and Defence officials, relating to such requests.
c. Internal TGA correspondence relating to proposed Defence use of tafenoquine, including minutes of meetings, records of conversation or emails.
d. Correspondence between TGA officials and GlaxoSmithKline relating to the proposed use of tafenoquine.
e. Written approvals by the TGA for Defence use of tafenoquine.
f. Reports from Defence officials to the TGA relating to adverse events experienced by ADF personnel administered tafenoquine during this period.
Although it is clear from publicly available evidence that Defence intended to use tafenoquine for the specific purpose of conducting clinical trials, what is not clear is whether this was properly reflected in any requests to the TGA. Defence may have inappropriately sought TGA approval under "compassionate use", the "special access scheme" or other provisions of the Therapeutic Goods Act. This FOI request seeks to identify whether Defence sought, or was granted, TGA approval to use tafenoquine for any purpose.
Yours faithfully,
Stuart McCarthy
*Stuart McCarthy, Therapeutic Goods Administration Approvals for Australian Defence Force Use of Tafenoquine in Bougainville and Timor Leste, 1999-2001, FOI request dated 3 May 2016. https://www.righttoknow.org.au/request/t...
Attention: Stuart McCarthy
FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT
I am writing to notify you that the Department of Health (Department) has received your request (in your below email) for access to documents under the Freedom of Information Act 1982 (FOI Act).
The Department will take all reasonable steps to notify you of a decision no later than 30 calendar days after the date your request was received. You will be contacted where a charge is applied for processing your request or if we need to consult a third party.
Unless you advise otherwise, duplicate documents and Commonwealth employee names and contact details below Senior Executive Service level and mobile telephone numbers of all staff will be excluded from the scope of your request.
You can contact the FOI Unit on (02) 6289 1666, or via email at [email address], should you have any enquiries.
Kind regards
FOI Officer
Ministerial, Parliamentary, Executive Support and Governance Branch
People, Capability and Communication Division
Australian Government Department of Health
T: (02) 6289 1666 | E: [TGA request email]
The Department of Health acknowledges the traditional owners of country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to elders both past and present.
Dear Mr McCarthy,
We refer to your FOI request received 15 July 2016 (FOI014-1617).
Following a search to identify documents held by the TGA, we advise that
the documents relevant to this request have also been identified as
relevant to your earlier FOI request with the TGA (FOI222-1516).
This means that no additional documents to those already identified in
your earlier FOI request (FOI222-1516) have been identified in relation to
your subsequent FOI request (FOI014-1617).
To avoid the same documents being provided to you twice, under the two
separate FOI requests, and to reduce any potential charges that may be
imposed, you may wish to consider withdrawing your FOI request FOI014-1617
and we will continue to process your earlier FOI request (FOI222-1516).
We would be grateful for your instructions on how you wish to proceed by
COB 10 August 2016.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards,
Jodie
Freedom of Information
Liz Santolin 02 6232 8664
Jodie Russell 02 6232 8720
Karen Bedford 02 6232 8772
Heather Davidson 02 6232 8988
Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2]cid:image004.png@01D10B4F.695253A0
References
Visible links
1. mailto:[email address]
Dear Mr McCarthy,
Please find attached correspondence in relation to your Freedom of
Information request.
As outlined in our email of 8 August 2016 (copy below), documents relevant
to this FOI request (FOI014-1617) have already been identified as relevant
to your earlier FOI request FOI222-1516.
To remove the need to process the same documents under separate requests,
and to reduce the cost involved to you in processing the two separate
requests, we encourage you to consider withdrawing this FOI request
(FOI014-1617). We will continue to process your earlier request
(FOI222-1516).
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards,
Jodie
Freedom of Information
Liz Santolin 02 6232 8664
Jodie Russell 02 6232 8720
Karen Bedford 02 6232 8772
Heather Davidson 02 6232 8012
Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2]cid:image004.png@01D10B4F.695253A0
From: TGA FOI
Sent: Monday, 8 August 2016 3:29 PM
To: '[FOI #2059 email]'
Cc: TGA FOI
Subject: Your FOI request - FOI014-1617 [SEC=UNCLASSIFIED]
Dear Mr McCarthy,
We refer to your FOI request received 15 July 2016 (FOI014-1617).
Following a search to identify documents held by the TGA, we advise that
the documents relevant to this request have also been identified as
relevant to your earlier FOI request with the TGA (FOI222-1516).
This means that no additional documents to those already identified in
your earlier FOI request (FOI222-1516) have been identified in relation to
your subsequent FOI request (FOI014-1617).
To avoid the same documents being provided to you twice, under the two
separate FOI requests, and to reduce any potential charges that may be
imposed, you may wish to consider withdrawing your FOI request FOI014-1617
and we will continue to process your earlier FOI request (FOI222-1516).
We would be grateful for your instructions on how you wish to proceed by
COB 10 August 2016.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards,
Jodie
Freedom of Information
Liz Santolin 02 6232 8664
Jodie Russell 02 6232 8720
Karen Bedford 02 6232 8772
Heather Davidson 02 6232 8988
Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]
[4]cid:image004.png@01D10B4F.695253A0
References
Visible links
1. mailto:[email address]
3. mailto:[email address]
Dear TGA FOI,
Given that the documents requested in FOI222-1516 were provided yesterday and your advice that no additional documents to those already identified in FOI222-1516 have been identified in relation to this FOI request (FOI014-1617), this request is hereby withdrawn.
Yours sincerely,
Stuart McCarthy