Dear Andrew

 

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

 

I am writing to notify you that the Therapeutic Goods Administration
(Department of Health and Aged Care) has received your request for access
to documents under the Freedom of Information Act 1982 (FOI Act) as
follows:

              

‘Could I please request access to the following relating to your 24 March
2020 intervention concerning hydroxychloroquine: "New restrictions on
prescribing hydroxychloroquine for COVID-19".

1. The press release mentioned "recent reports of increased off-label
prescribing of medicines containing hydroxychloroquine". Could the TGA
please provide the sources of the "recent reports" and the documents which
show how these reports were verified?

2. The press release also stated "Given the limited evidence for effect
against COVID-19". Could the TGA please provide the evidence that was
assessed in making this decision?’

 

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
from the date your request was received in which to provide a decision in
response to your request for access. A decision is currently due on or
before 17 February 2025. Due to the statutory processing time afforded
under the FOI Act in which to provide you with a decision in relation to
your FOI request, we would be grateful if you could please monitor your
emails periodically for updates regarding your request.

 

Where there is requirement to undertake consultation with affected third
parties, this timeframe is extended by a further 30 days. It may also be
extended in certain circumstances, including with your agreement or where
the Department applies to the Office of the Australian Information
Commissioner for an extension.

 

Unless you advise otherwise, draft and duplicate documents, Commonwealth
employee names and contact details of staff below Senior Executive Service
level, internal group email addresses and mobile telephone numbers of all
staff will be excluded from the scope of your request under section
22(1)(a)(ii) of the FOI Act.

 

Disclosure Log Publication

The TGA is required under section 11C of the FOI Act to publish on its
website, or otherwise make available, documents released to an applicant
in response to an FOI request, unless exceptional circumstances apply. The
TGA publishes these documents on the FOI Disclosure Log at [1]FOI
Disclosure Log | Therapeutic Goods Administration. You can find more
information about the Disclosure Log at [2]OAIC FOI Guidelines |
Disclosure Logs.

 

Personal information

I note that your request doesn’t specify whether you seek access to the
personal information of third parties (e.g. the names and contact details
of individuals, or any information that could reasonably identify an
individual). Seeking this information may require the Department to
consult with the identified individuals. This will increase the time taken
to process your request and the costs involved. As such, we would be
grateful if you would consider removing the personal information of third
parties from the scope of your request. 

 

In addition, please note that if the decision maker decides that you are
liable to pay a charge in relation to your request then this timeframe is
extended pending payment of a deposit. You will be notified by the
Department if you are liable to pay a charge and/or if third party
consultation is required.

 

I would be grateful if you could respond to this email by COB tomorrow,
Wednesday 22 January 2025 so that we may continue processing your request.

 

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [3][email address].

 

Kind regards

 

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health and Aged Care
Address: PO Box 100, Woden ACT, 2606, Australia
Email: [4][email address]

+ 61 2 6289 4630

 

Important: This transmission is intended only for the use of the addressee
and may contain confidential or legally privileged information. If you are
not the intended recipient, you are notified that any use or dissemination
of this communication is strictly prohibited. If you receive this
transmission in error please notify the author immediately and delete all
copies of this transmission.

 

 

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