Therapeutic Goods Administration Approvals for Australian Defence Force Use of Tafenoquine in Clinical Trials, 1999-2000

Stuart McCarthy made this Freedom of Information request to Therapeutic Goods Administration

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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...

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-----Original Message-----
From: Stuart McCarthy [mailto:[FOI #2059 email]]
Sent: Friday, 15 July 2016 11:38 AM
To: FOI
Subject: Freedom of Information request - Therapeutic Goods Administration Approvals for Australian Defence Force Use of Tafenoquine in Clinical Trials, 1999-2000 [SEC=No Protective Marking]