The evidence relied upon by the TGA to restrict access to hydroxychloroquine in 2020
Dear Therapeutic Goods Administration,
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?
Kind regards
Andrew
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.
Dear TGA FOI,
Thank you for your email.
I confirm that I am aware of the matters raised in your reply and would like to proceed with the FOI request.
Yours sincerely,
Andrew
Dear Andrew
Thank you for your response and confirmation below.
For response - Personal information
I require your confirmation on 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.
I would be grateful for your response by COB today, Wednesday 22 January
2025.
If you have any questions or concerns, please don’t hesitate to contact
the TGA FOI team.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [1][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [2]www.tga.gov.au
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.
The Department of Health and Aged Care acknowledges the Traditional
Custodians of Australia and their continued connection to land, sea and
community. We pay our respects to all Elders past and present.
Dear TGA FOI,
My apologies for the oversight.
Yes, I confirm I am not seeking access to the names or information of third parties with my FOI request.
Kind regards,
Andrew
Dear Andrew
Please find attached correspondence in relation to your Freedom of
Information request.
IMPORTANT: Please include reference to FOI 25-0116 in your payment.
Consultation
As your request relates to the personal, professional, business,
commercial or financial affairs of third parties, pursuant to section 27
and 27A of the FOI Act, the TGA is required to consult with the affected
third parties and provide them an opportunity to make submissions
regarding the release of the documents.
Accordingly, under section 15(6) of the FOI Act, and upon payment of a
deposit, the timeframe for processing your request will be extended by 30
days to allow the consultation process to be conducted.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
Address: PO Box 100, Woden ACT, 2606, Australia
E: [1][email address]
T: + 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.
"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."
References
Visible links
1. mailto:[email address]
Dear TGA FOI,
Could you please confirm that my FOI request does not relate to the personal, professional, business, commercial or financial affairs of third parties? My correspondence from January 22 2025 stated:
- "Yes, I confirm I am not seeking access to the names or information of third parties with my FOI request."
However, the correspondence received yesterday (7 February 2025) stated:
- "As your request relates to the personal, professional, business, commercial or financial affairs of third parties, pursuant to section 27 and 27A of the FOI Act, the TGA is required to consult with the affected third parties and provide them an opportunity to make submissions regarding the release of the documents."
This seems to be a misunderstanding of my request which would mean that the charge may be incorrect.
Could you please confirm?
Kind regards.
Dear Andrew
Thank you for your email.
I can confirm that your response of 22 January 2025 was interpreted to be
in response to the question of whether you were seeking the personal
information of third parties i.e ‘…any information that could reasonably
identify an individual).’
Should you additionally not seek access to third party business/commercial
information, the TGA would be happy to proceed to the notice of decision
stage upon payment of a deposit as outlined in the estimate of charges
notice issued to you on 7 February 2025. Please note that these charges
are a preliminary estimate only and includes the first five hours of
decision making at no cost. In accordance with the Freedom of Information
(Charges) Regulations 2019 (the Charges Regulations) the actual charges
that can be imposed for processing your request will be calculated at the
decision stage. Should the final charges the estimate of charges provided
to you, the Charges Regulations provides that a higher amount than the
estimate can only be charged if providing full access to the documents.
We would be grateful for your confirmation of our recent interpretation
that you also do not seek third party business/commercial information.
Your response would be appreciated by Tuesday, 11 February 2025 and we
thank you for your time.
Should you have any further questions, please don’t hesitate to contact
the TGA FOI team.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [1][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [2]www.tga.gov.au
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.
The Department of Health and Aged Care acknowledges the Traditional
Custodians of Australia and their continued connection to land, sea and
community. We pay our respects to all Elders past and present.
Dear TGA FOI,
Thank you for confirming your interpretation of my request that I do not seek the information of third parties etc.
Could I please confirm that the original search for records relating to my request have not inflated the costs of the FOI due to extra searches being conducted that might include the information of third parties etc.?
Yours sincerely,
Andrew
Dear Andrew
Thank you for your email.
We confirm that original search for records relating to your request ‘have
not inflated the costs of the FOI due to extra searches being conducted
that might include the information of third parties etc.’
Should you have any further questions, we would be happy to assist you.
Kind regards
Freedom of Information
Therapeutic Goods Administration
Australian Government Department of Health and Aged Care
T: 02 6289 4630 | E: [1][email address]
PO Box 100, Woden ACT 2606, Australia
Web: [2]www.tga.gov.au
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.
The Department of Health and Aged Care acknowledges the Traditional
Custodians of Australia and their continued connection to land, sea and
community. We pay our respects to all Elders past and present.