Scheduling of Thymosin Beta 4 and Tb500

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

Currently waiting for a response from Advisory Committee on Medicines Scheduling, they must respond promptly and normally no later than (details).

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

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From: TGA FOI
Advisory Committee on Medicines Scheduling


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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

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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


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Attachment D19 5512231 FOI1132 1819 Notification of Estimate of Charges.pdf
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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

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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

From: TGA FOI
Advisory Committee on Medicines Scheduling


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Attachment Receipt 1400067323.pdf
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Dear Mr O'Dea

 

Thank you for your email and my apologies for the delay in responding.

 

I note that you have now paid the deposit required for the processing of
your FOI request.  Please find attached a receipt for your payment.

 

A refund is not refundable unless TGA fails to make a decision within the
legislated timeframes. At this stage, a decision is currently due to you
by 16 June 2019.

 

Consultation has already commenced with relevant third parties.  Should
any submissions be received from those third parties, the decision maker
will consider those responses in order to make their decision.

 

If you do not require the identity of any parties mentioned in the
document this may reduce the time taken to finalise the request and
streamline the process.  Could you please advise whether you require
access to personal information (specifically the name and contact details
of the applicant)?

 

Kind regards
Karen

 

Freedom of Information
Kyla | Heather | Karen | Tara

(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

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From: Robert O'Dea

Delivered

Dear TGA FOI,

Dear Karen,

Thanks for the response. I am currently overseas but, at the moment, I am able to respond.

I did state in my previous email that I was prepared to accept the 27 pages identified as meeting my requirements with the name(s) and contact details redacted, if that facilitated an earlier release of these documents.

I am interested to understand a statement you have made in a previous relating to the Privacy Act where business, financial, commercial etc interests of the applicants are affected. I fail to understand how an application of scientific/medical content affects these interests.

As I have previously stated I have been advised by the TGA by email that I can make a submission to the Scheduling Branch on the Scheduling of Thymosin Beta 4 via a protocol provided to me. I repeat what I said in my previous email that having an appeal process, by any reasonable logic should allow the appellant access to the full application, which includes the technical and scientific evidence.

In answer to your question I do not require the applicants name or contact details
Yours sincerely,

Robert O'Dea
Robert O'Dea

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From: TGA FOI
Advisory Committee on Medicines Scheduling


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Dear Mr O’Dea

 

During the consultation process, a third party has requested to know the
identity of the applicant.

 

The third party has been advised that all FOI applicants are entitled to
remain anonymous under the FOI Act. However, could you please indicate
whether or not you agree to the disclosure of your identity to the third
party?

 

We would be grateful if you could please respond by COB Tuesday 4 June
2019.

 

Kind regards

 

Freedom of Information
(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

 

 

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From: Robert O'Dea

Delivered

Dear TGA FOI,

I request that my name and contact details are not disclosed to the third party, as you have kindly advised me, is my right under the FOI Act

Yours sincerely,

Robert O'Dea

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From: Robert O'Dea

Delivered

Dear TGA FOI,

I have already responded to your email above that I received on the 31st May. My response was sent on the 1st June, the content of which is below.

I request that my name and contact details are not disclosed to the third party, as you have kindly advised me, is my right under the FOI Act

Yours sincerely,

Robert O'Dea

Link to this

From: TGA FOI
Advisory Committee on Medicines Scheduling

Dear Mr O'Dea

We are currently processing a decision in relation to your FOI request. In doing so, we would like to confirm the scope of your response, below, in relation to personal information. You state that you do not wish to obtain personal information of the scheduling applicant, other than their name. However, could we please confirm whether you seek the personal information of other individuals named within the documents?

Your response by cob Wednesday 12 June 2019 would be greatly appreciated.

Thank you

Kyla

Freedom of Information
Kyla | Heather | Karen |  Tara
(02) 6232 8806
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: Robert O'Dea

Delivered

Dear TGA FOI,

Thankyou for the response.

As I indicated in previous emails from the 16th May and more recently, the 29th May, if the name and personal details of the applicant was going to delay the release of the relevant documents then I was willing to accept the documents with the name and personal details of the applicant redacted.

Therefore let me state that I do not need the name and personal details of the applicant.

If there are other names and personal information within the application documents that are not those of the applicant then I would request the NAMES ONLY be made available to me, especially where they are linked to the evidence.

What I require is the completed application protocol in the standard format with all relevant scientific papers, research studies, clinical studies, and other evidence to support the application. I would also request a bibliography of all references quoted within the application.

Yours sincerely,

Robert O'Dea

Link to this

From: TGA FOI
Advisory Committee on Medicines Scheduling


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Dear Mr O'Dea

 

Thank you for your response.

 

In your email of 29 May 2019 we understood that you did not require then
names of the applicant or any other names (including any associated
personal information).  As such, we have been processing your request with
this in mind.

 

Should you require access to the names of other third parties as stated in
your email of 11 June 2019, it would be necessary for the TGA to conduct
further consultation.

 

Could you please clarify if you are seeking the names of other third
parties.  If you do require this information it has become apparent that
the TGA would require an extension of time due to the need to consult
additional third parties. I would be grateful if you could please consider
agreeing to an extension (under section 15AA) of thirty (30) days for the
processing of your request. If you agree to this extension the decision on
your request would then be due on or before 16 July 2019.

 

I apologise for the short notice, but your response to whether you seek
other third party personal information and consequently agree to this
extension by COB Thursday 13 June 2019 would be greatly appreciated.
 Alternatively, If you are not seeking access to any third party personal
information, you can simply reply: 'no third party personal information
requested'.

 

Thank you for your consideration of this matter.

 

Please do not hesitate to contact the FOI team if you have any questions.

 

Thank you

Karen

 

Freedom of Information
Kyla | Heather | Karen | Tara

(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

 

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From: Robert O'Dea

Delivered

Dear TGA FOI,

Thankyou for the response.

As I have stated many times I am willing to have the applicant details redacted. Can I assume there is only one applicant?

You mention third parties named within the application. I am a little confused as to the context in which you mention these third parties? Given that an Application for the Scheduling of a substance contains technical/scientific data in support of the application then I expect that the author's names of these papers, reports etc are provided.

Can you define for me or provide examples of these third parties or how their input is utilised when considering the application. If third parties are consulted as "experts" and provide technical support in the consideration of the application is their input included in the document trail. I would ask that this information be provided. If this is an example of a "third party" please advise.

Once I have clarification on who these third parties might be I will be better able to provide you with advice on my submission and move forward in gaining access to the documents.

Yours sincerely,

Robert O'Dea

Link to this

From: TGA FOI
Advisory Committee on Medicines Scheduling

Dear Professor O'Dea

We are unable to provide specific information about the identities of the third parties other than to say they are referred to in the application and they are not authors of publicly available studies.

If you wish to obtain the names or other personal information for these third parties, your response by COB Thursday 13 June 2019 would be greatly appreciated. However, as mentioned below, if this information is sought we will be required to commence a consultation process with those third parties. If this is the case the TGA would require an extension of time and would be grateful if you could please consider agreeing to an extension (under section 15AA) of thirty (30) days. If you agree to this extension the decision on your request would then be due on or before 16 July 2019.

Thank you for your consideration.

Kyla

Freedom of Information
Kyla | Heather | Karen |  Tara
(02) 6232 8806
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: Robert O'Dea

Delivered

Dear TGA FOI,

I appreciate your prompt response.

Thanks for the information about the "third parties", especially your comment that these "third parties"are not the authors of publicly available studies.

I am intrigued to know the identities of these "third parties", their designations and what influence/input they provided on the decision to schedule TB4 and the published reasons for the scheduling (on the TGA website).

Therefore I am requesting, within the scope of my FOI request, the names and titles of these "third parties".

I agree to your request to extend the time of completion by 30 days to allow time for you to consult with these "third parties".

Could you advise me if these "third parties" do not agree to disclose their names and titles will I still be able to gain access to the Scheduling Application File, previously identified as being 27 pages, with the names and designations of the "third parties redacted?

Yours sincerely,

Robert O'Dea

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From: TGA FOI
Advisory Committee on Medicines Scheduling

Dear Mr O'Dea

Thank you for granting the extension to consult with the third parties.

I can advise that the exemption (or not) of third party personal information is independent of the decision to release the remainder of the document, noting that its release in full or in part is still subject to the application of any other required exemptions.

We will commence consultation with the third parties. The decision is currently due on or before 16 July 2019.

Thank you

Kyla

Freedom of Information
Kyla | Heather | Karen | Tara
(02) 6232 8806
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

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From: Robert O'Dea

Delivered

Dear TGA FOI,

Thankyou for the information. I look forward to your next correspondence.

Yours sincerely,

Robert O'Dea

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