Scheduling of Thymosin Beta 4 and Tb500

Robert O'Dea made this Freedom of Information request to Advisory Committee on Medicines Scheduling

The request is waiting for clarification. If you are Robert O'Dea, please sign in to send a follow up message.

From: Robert O'Dea

Delivered

Dear Advisory Committee on Medicines Scheduling,

I make this request under the FOI Act.

My request relates to the request submitted to the TGA for Scheduling of Thymosin Beta 4 and Tb500 as indicated in the link below.

https://www.tga.gov.au/book-page/27-perf....

I am requesting specifically access to the application for inclusion of Thymosin Beta 4 and Tb500 on the Schedules List. I would request all supporting data that was presented in the application that supports the claims.

Any/all clinical and scientific evidence that supports the claims of performance and image enhancement.

Any evidence that supports any medical benefit at all from the use of Thymosin Beta 4 or Tb500.

I would ask for clarification on what appears to be a contradiction in the rationale for the acceptance of the application. The reasons state limited evidence of therapeutic benefits, not registered anywhere in the world (by definition no clinical evidence of efficacy or safety), experimental and yet it is accepted as being performance and image enhancing.

I look forward to your response.

Yours faithfully,

Bob O'Dea

Link to this

From: TGA FOI
Advisory Committee on Medicines Scheduling


Attachment image001.png
3K Download


Dear Mr O’Dea

FREEDOM OF INFORMATION REQUEST – NOTIFICATION OF RECEIPT

I am writing to notify you that the Department of Health (Department) has
received your request for access to documents under the Freedom of
Information Act 1982 (FOI Act).

                “…the request submitted to the TGA for Scheduling of
Thymosin Beta 4 and Tb500 as indicated in the link below.

 

[1]https://www.tga.gov.au/book-page/27-perf....

 

I am requesting specifically access to the application for inclusion of
Thymosin Beta 4 and Tb500 on the Schedules List. I would request all
supporting data that was presented in the application that supports the
claims.

 

Any/all clinical and scientific evidence that supports the claims of
performance and image enhancement.

 

Any evidence that supports any medical benefit at all from the use of
Thymosin Beta 4 or Tb500.

 

I would ask for clarification on what appears to be a contradiction in the
rationale for the acceptance of the application. The reasons state limited
evidence of therapeutic benefits, not registered anywhere in the world (by
definition no clinical evidence of efficacy or safety), experimental and
yet it is accepted as being performance and image enhancing.”

Under section 15(5)(b) of the FOI Act, the agency has 30 calendar days
after 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 May 2019.

However, 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.

 

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.

 

PROCESSING YOUR REQUEST

To assist us to streamline the processing of your request we ask you to
consider and respond to the following questions.

 

1.       Personal Information

Documents containing personal information, (e.g. the names and contact
details of any individuals, or any information that could reasonably
identify an individual) may require the Department to consult with the
identified individuals or parties. This consultation is likely to add to
the time taken to process your request, and potentially increase the
charge imposed on you.

 

We would therefore be grateful if you could confirm if you are seeking
access to personal information in the documents (e.g. names, contact
details, addresses) relating to:

·         third parties; and

·         Commonwealth staff (please note that unless you advise
otherwise, we will assume that you do not seek access to personal
information of Commonwealth employees below Senior Executive Service
level).

 

If you are not seeking access to any personal information, you can simply
reply: 'no personal information requested'.

 

If you are seeking access to specific types of personal information,
please specify the type of personal information you require.

 

2.       Duplicate Documents

Under section 4(1) of the FOI Act, the definition of a document includes
‘any copy, including an part of any copy, of a reproduction or duplicate’.
Confirmation that you are not seeking duplicate documents may enable more
timely and less costly processing of your request.

 

Can you please clarify if you are seeking duplicate copies, either in part
or in full, as part of your request?

 

If you are not seeking access to duplicate documents, you can simply
respond: ‘no duplicates requested’.

 

We look forward to hearing from you by COB Tuesday 23 April 2019.

If you have any queries, please contact the FOI team on (02) 6232 8806, or
via email at [2][email address].

Kind regards

Karen

 

Freedom of Information
Kyla | Karen | Tara | Cindy

(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [3][email address]

 

[4]cid:image001.png@01D1D5D9.7DDEADA0

show quoted sections

Link to this

From: Robert O'Dea

Delivered

Dear TGA FOI,

I am responding to questions asked in your response to my FOI request submitted on the 17th April, 2019 titled "Scheduling of Thymosin Beta 4 and Tb500"

1. Personal Information

I have asked for a copy of the application made to the TGA Scheduling Division for the scheduling of TB4 and Tb500. I assume the applicant's name and/or the organisation he/she represents would appear on the application. In that case the name but no other personal or contact information is necessary. I assume the applicant would be a senior executive in the organisation or senior scientist or medical practitioner.

2. Duplicate Documents

I do not believe that I need duplicate documents. What I request is an exact and full copy of the application for Scheduling of Thymosin Beta 4 and Tb500 which includes all attachments, references, bibliography of those references, scientific data and other information that must be included in the Application Form to amend the Poisons Standard.

Yours sincerely,

Robert O'Dea

Link to this

From: TGA FOI
Advisory Committee on Medicines Scheduling


Attachment image001.png
3K Download

Attachment D19 5512231 FOI1132 1819 Notification of Estimate of Charges.pdf
950K Download View as HTML

Attachment credit card payment authorisation.pdf
86K Download View as HTML


Dear Mr O'Dea

 

Please find attached correspondence in relation to your Freedom of
Information request.

 

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 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

Karen

 

Freedom of Information
Kyla | Karen | Tara | Cindy

(02) 6232 8806

Reporting and Collaboration Services Section

Regulatory Engagement and Planning Branch

Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

[2]cid:image001.png@01D1D5D9.7DDEADA0

show quoted sections

Link to this

From: Robert O'Dea

Delivered

Dear TGA FOI,

Thankyou for the feedback on my application.

I contend that details of the applicant will be contained within the original application document. If the Privacy Act 1988 prevents release of this information can this information be redacted so as to not delay release of the remainder of application by the suggested 30 days?

I intend to lodge an application to amend the Poisons Standard but I cannot do so without reviewing the original application and the technical content of it. If the TGA Management System allows for an application for amendment of a Scheduling decision then surely it is reasonable request that all the information is made available for review.

I notice from your attachment that the information I am requesting is contained within 27 pages and that there is a cost attached. If I was to forward the 25% deposit and my application is denied do I receive a refund?

Yours sincerely,

Robert O'Dea

Link to this

Things to do with this request

Anyone:
Advisory Committee on Medicines Scheduling only: