applications to import unapproved therapeutic goods under TGA's Special Access Scheme, 2015 to mid-2017
faustus made this Freedom of Information request to Therapeutic Goods Administration
This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.
Dear Madam/Sir,
With respect to applications to import unapproved therapeutic goods under TGA's Special Access Scheme between 2015 to mid-2017, I kindly request the following information:
List of drugs for which authority to import was sought (grouped by generic name)
- Total number of applications, grouped by outcome (approved/rejected)
- For applications grouped by outcome, total number of applications by patient category (Category A/B)
For clarity, supposing there have been 20 applications in total to import somecompound hydrochloride under the Special Access Scheme. Structure of data sought might be as follows:
-----
somecompound hydrochloride (total applications = 20)
Approved (total = 19)
- Category A (total = 15)
- Category B (total = 4)
Rejected (total = 1)
- Category A (total = 0)
- Category B (total = 1)
-----
I trust that this request is not an onerous one and that it will not incur any processing fees. If this is not the case, please advise on possible ways that I might narrow the scope of the request.
I thank you for your assistance.
faustus
Dear Faustus
I refer to your FOI request of 1 July 2017 to the Therapeutic Goods
Administration (TGA) seeking access to certain information relating to the
Special Access Scheme.
Section 15 of the FOI Act requires that a request for documents meets
certain requirements. Your request, in its current form, does not
constitute a valid request. Please note that the Act provides for access
to documents and not to 'information'. In order for your request to be
processed under the provisions of the FOI Act you must provide us with
further information to enable us to identify the document or documents you
are seeking.
Furthermore, in relation to your request for the data to be in a
particular order, the documents you are seeking must already be in
existence and there is no requirement for the TGA to create a document for
the purposes of an FOI request. Therefore any information contained in
documents in the TGA’s possession may or may not be in the order/grouping
you requested.
You should also be aware that in relation to Category A of the Special
Access Scheme the TGA does not authorise supply. The TGA just receives
notification of the supply. The Special Access Scheme, which is a scheme
to authorise supply of unapproved products, is also separate from the
process required to authorise the importation of the product that is
authorised to be supplied under the Special Access Scheme.
In order to make your request valid, you may wish to consider submitting
the following scope:
“With respect to applications to supply unapproved therapeutic goods under
TGA's Special Access Scheme between 1 January 2015 to 30 June 2017, I
kindly request the following documents:
1. List of drugs for which supply was notified (Category A) or authority
to supply was sought (Category B);
2. Total number of applications approved/rejected in relation to Category
B;
3. Total number of applications by Category A/B.”
Please note that this scope is an example only. At this early stage, a
search and retrieval has not been conducted and the TGA is unable to
advise on whether it may be too voluminous to process or if any documents
will be returned.
Alternatively, I would greatly appreciate if you could provide us with
more information on the specific documents that you require.
Please don't hesitate to contact me should you have any further questions.
Kind regards
Jacki
Freedom of Information
(02) 6232 8612
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@01D2F408.3F1C7130
Dear Jacki,
I thank you for your response dated 3 July, 2017. I note that you are unable to fulfil my FOI request in its present form. In light of your recommendations, I will clarify the nature of my request, and modify the specificity of the data being sought.
AIM
Broadly, I would like an idea of what therapeutic agents are being processed under the Special Access Scheme, and the relative demand for each agent as reflected by the number of submissions for each agent.
SCOPE
Records. Although the documents that the TGA holds is unclear, I imagine that the granularity of the records proceeds in the following stepwise manner:
1. List of therapeutic agents submitted under the SAS;
2. As above, with information regarding number of submissions per agent;
3. As above, with information regarding number of submissions by Category (A/B/C);
4. As above, with information regarding medical condition, diagnosis, or indication;
5. As above, with information regarding number of applications rejected (Category B)
Realistically, I would anticipate that you might be able to identify a single recording containing the information in #3 -- some sort of document grouped by Category A, B, and C, and a list of agents in each group.
Date. The previous date range 01/01/2015-30/06/2017 was arbitrary. I am amenable to any relatively recent records of what agents have been approved. Ideally, I would like information spanning a period of two or more years.
Record type. Perhaps a spreadsheet comprising raw data of date, therapeutic agent, SAS Category and indication; a report summarising SAS submissions over the previous calendar year.
I trust that the above clarifies my request for you. However, should you encounter any problems please advise and I will adjust accordingly.
Many Thanks,
faustus
Dear Faustus,
Your request has been discussed with the relevant area and they have
indicated that information in the following fields could be provided to
you in table format for date range 01/01/2015-30/06/2017:
· Therapeutic good
· Date of application
· Category (A, B or C)
· Indication
· Status (that is approved or rejected)
Please note that medical condition, diagnosis and indication are different
things. For example an individual may be diagnosed with cancer but the
Special Access Scheme (SAS) application may be for a medication to treat
nausea associated with the cancer. In this example the diagnosis is cancer
but the indication is nausea. Only the indication for an SAS application
is recorded in searchable form. Additional work would be required to
provide information in relation to medical condition or diagnosis.
The area has also indicated that it would take four weeks to compile the
information.
Can you please respond by 1 August 2017 indicating whether the proposed
information to be provided and the timeframe are acceptable.
Regards,
Jacki
Freedom of Information
(02) 6232 8612
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
Dear Faustus
I am writing to follow up a response to email in relation to the scope of
your request which was sent to you on 27 July 2017.
As the due date for your response has now passed, I would be very grateful
if you could please provide a response by COB Monday 7 August 2017.
Kind regards
Heather
Freedom of Information
(02) 6232 8612
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
From: TGA FOI
Sent: Thursday, 27 July 2017 12:45 PM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Invalid FOI Request [SEC=UNCLASSIFIED]
Dear Faustus,
Your request has been discussed with the relevant area and they have
indicated that information in the following fields could be provided to
you in table format for date range 01/01/2015-30/06/2017:
· Therapeutic good
· Date of application
· Category (A, B or C)
· Indication
· Status (that is approved or rejected)
Please note that medical condition, diagnosis and indication are different
things. For example an individual may be diagnosed with cancer but the
Special Access Scheme (SAS) application may be for a medication to treat
nausea associated with the cancer. In this example the diagnosis is cancer
but the indication is nausea. Only the indication for an SAS application
is recorded in searchable form. Additional work would be required to
provide information in relation to medical condition or diagnosis.
The area has also indicated that it would take four weeks to compile the
information.
Can you please respond by 1 August 2017 indicating whether the proposed
information to be provided and the timeframe are acceptable.
Regards,
Jacki
Freedom of Information
(02) 6232 8612
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
Dear Heather,
Thank you for your response and please accept my apologies in the lateness of my reply.
In my previous correspondence with Jacki, it has been noted that the following information is available with regards to my FOI request:
Table format for date range 01/01/2015-30/06/2017:
- Therapeutic
- Date of application
- Category (A, B or C)
- Indication
- Status (that is approved or rejected)
This is perfectly adequate for my needs and I am happy for you to proceed with this request.
Many Thanks,
faustus
Dear Faustus,
The relevant area has provided further detail on what information they can
provide:
Category A
For Category A, this is a notification only, therefore, ‘Status’ and
‘application date’ are irrelevant, and we don’t collect an ‘Indication’.
Therefore, we can provide:
· Category
· Therapeutic good
Category B
For Category B, we can’t provide an ‘Indication’ but we could provide
‘Diagnosis Clinical Justification’ if that is acceptable? We propose to
provide the following:
· Category
· Date of Application
· Therapeutic good
· Diagnosis Clinical Justification
· Status
Category C
This pathway only became available from 3 July 2017 and therefore will be
no information available for this.
The area propose that they can provide you with two excel spreadsheets
with the above information for categories A and B.
Can you confirm that the above proposed information is acceptable.
Regards,
Jacki
Freedom of Information
(02) 6232 8612
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
Dear Faustus,
I am following up on the below email to ask if you could respond by 11
August 2017.
In addition as previously advised the relevant area has indicated that it
will take four weeks to compile the requested information. Due to this, I
would be grateful if you could please consider agreeing to an extension
(under section 15AA) of fourteen (14) days for the processing of your
request. The decision on your request would become due by 2 September
2017. Could you respond advising whether you agree to this extension by 11
August 2017.
Regards,
Jacki
Freedom of Information
(02) 6232 8612
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
From: TGA FOI
Sent: Friday, 4 August 2017 9:11 AM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]
Dear Faustus,
The relevant area has provided further detail on what information they can
provide:
Category A
For Category A, this is a notification only, therefore, ‘Status’ and
‘application date’ are irrelevant, and we don’t collect an ‘Indication’.
Therefore, we can provide:
· Category
· Therapeutic good
Category B
For Category B, we can’t provide an ‘Indication’ but we could provide
‘Diagnosis Clinical Justification’ if that is acceptable? We propose to
provide the following:
· Category
· Date of Application
· Therapeutic good
· Diagnosis Clinical Justification
· Status
Category C
This pathway only became available from 3 July 2017 and therefore will be
no information available for this.
The area propose that they can provide you with two excel spreadsheets
with the above information for categories A and B.
Can you confirm that the above proposed information is acceptable.
Regards,
Jacki
Freedom of Information
(02) 6232 8612
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
Dear Faustus
The TGA is currently processing your FOI request. As we have not had a
response to our previous email, I am writing to advise that we will be
proceeding with the following scope:
“With respect to applications to import unapproved therapeutic goods under
TGA's Special Access Scheme between 1 January 2015 to 30 June 2017, I
kindly request the following information:
Category A
· Category
· Therapeutic good
Category B
· Category
· Date of Application
· Therapeutic good
· Diagnosis Clinical Justification
· Status”
Category C
Please note, there no documents in existence for this point as the
Category C pathway only became available from 3 July 2017.
Could you also please advise whether or not you agree to an extension
(under section 15AA) of fourteen (14) days to the processing time for your
request by Thursday 17 August 2017.
Kind regards
Karen
Freedom of Information
(02) 6232 8720
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
From: TGA FOI
Sent: Tuesday, 8 August 2017 12:15 PM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]
Dear Faustus,
I am following up on the below email to ask if you could respond by 11
August 2017.
In addition as previously advised the relevant area has indicated that it
will take four weeks to compile the requested information. Due to this, I
would be grateful if you could please consider agreeing to an extension
(under section 15AA) of fourteen (14) days for the processing of your
request. The decision on your request would become due by 2 September
2017. Could you respond advising whether you agree to this extension by 11
August 2017.
Regards,
Jacki
Freedom of Information
(02) 6232 8612
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
From: TGA FOI
Sent: Friday, 4 August 2017 9:11 AM
To: 'faustus'
Cc: TGA FOI
Subject: RE: FOI 002-1718 - Clarify scope [SEC=UNCLASSIFIED]
Dear Faustus,
The relevant area has provided further detail on what information they can
provide:
Category A
For Category A, this is a notification only, therefore, ‘Status’ and
‘application date’ are irrelevant, and we don’t collect an ‘Indication’.
Therefore, we can provide:
· Category
· Therapeutic good
Category B
For Category B, we can’t provide an ‘Indication’ but we could provide
‘Diagnosis Clinical Justification’ if that is acceptable? We propose to
provide the following:
· Category
· Date of Application
· Therapeutic good
· Diagnosis Clinical Justification
· Status
Category C
This pathway only became available from 3 July 2017 and therefore will be
no information available for this.
The area propose that they can provide you with two excel spreadsheets
with the above information for categories A and B.
Can you confirm that the above proposed information is acceptable.
Regards,
Jacki
Freedom of Information
(02) 6232 8612
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [5][email address]
[6]cid:image001.png@01D1D5D9.7DDEADA0
Dear Karen,
Thank you for your e-mail.
I must apologise again for the lateness of my reply -- I am utilising the public FOI service Right To Know (www.righttoknow.org.au) and have not been receiving notifications. However, I have made the appropriate modifications and will now be able receive and therefore respond to any additional correspondence of yours in a timely manner.
With respect to the proposed scope of my FOI request, what you are proposing is entirely acceptable. However, if I may, I was wondering if I could also request the following:
For Category A and B, would the name of the clinician submitting the request/notification be available? If so, is it possible for you to anonymise the clinician's name using a crypotographic hash function and include that as an additional column in the spreadsheet? In short, I have no interest in knowing the actual clinician's name, but do have an interest in knowing how the prescribing practices of any particular clinician might be contributing to the absolute number of SAS requests and/or notifications for a specific therapeutic agent. However, if you are unable to do this then it is entirely fine -- please proceed as you otherwise would.
Also, regarding your request for a deadline extension: yes, by all means please take your time processing this request.
I look forward to hearing from you.
Best Regards,
faustus
Dear Faustus
Thank you for your email and accepting the proposed scope for your
request.
In relation to the additional information requested in your email of 16
August 2017, I will need to seek the views of the relevant line area in
order to provide a response. As such, I would be grateful if you could
please consider agreeing to an additional extension (under section 15AA)
of fourteen (14) 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 September 2017.
Could you please respond advising whether you agree to this extension by
COB Thursday 24 August 2017.
Thank you for your consideration of this matter.
Please do not hesitate to contact me if you have any questions.
Kind regards
Heather
Freedom of Information
(02) 6232 8720
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
Dear Heather,
Thank you for your reply. Per your e-mail, an extension in fulfilling my FOI request is acceptable.
Best,
faustus
Dear Faustus,
We refer to your FOI request FOI002-1718 currently being processed by the TGA and to your query dated 16 August 2017 (copy below).
Following discussions with our line area, we advise that to undertake the additional task of anonymising the clinician's name using a crypotographic hash function would be a substantially onerous task and potentially not possible to carry out.
As you previously indicated your agreement to proceed without this information, the TGA intends to continue processing your FOI request on that basis.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards,
Freedom of Information
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]
Dear Faustus,
Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 20 July 2017.
I am writing to inform you that, whilst undertaking the search and
retrieval process the line area have advised that it appears the scope of
your request may be too voluminous.
Currently, the search and retrieval process has revealed over 11,000 SAS
Category B medical devices and biological applications relevant to the
scope of your request.
The line area have advised that to provide the diagnosis/clinical
justification for these SAS Category B applications would require someone
sorting through over 11,000 hard copy forms to extract the information
manually. This information can however be provided for medicines
applications.
In order to reduce your scope to a size that is more manageable, you may
wish to consider revising the scope of your request to exclude
diagnosis/clinical justification for medical device and biological SAS
Category B applications.
For example, you may wish to consider submitting the following the revised
scope:
“With respect to applications to import unapproved
therapeutic goods under TGA’s Special Access Scheme between 1 January 2015
and 30 June 2017, I kindly request the following information:
Category A:
-Category
-Therapeutic Good
Category B:
-Category
-Date of Application
-Therapeutic Good
-Status
-Diagnosis Clinical Justification (for medicines only).”
We would be grateful for your response by COB Monday 28 August 2017.
Please don't hesitate to contact me if you have any questions or if you
would like to discuss this.
Kind regards
Jodie
Freedom of Information
(02) 6232 8720
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
Dear Faustus,
We refer to our email of 25 August 2017 (copy below).
Upon further investigation, we have subsequently been advised by the
relevant line area the requested information relating to
diagnosis/clinical justification for the Medicine, Biological and Medical
Device applications for SAS Category B can be retrieved from the TGA’s
systems electronically, rather than manually from the application forms
themselves.
Accordingly, the TGA is able to continue processing your FOI request with
the revised scope as at 14 August 2017.
We apologise for any confusion caused.
If you have any questions, please do not hesitate to contact the FOI Team.
Kind regards,
Freedom of Information
(02) 6232 8720
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
From: TGA FOI
Sent: Friday, 25 August 2017 9:17 AM
To: 'faustus'
Cc: TGA FOI
Subject: FOI002-1718 - Scope revision [SEC=UNCLASSIFIED]
Dear Faustus,
Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 20 July 2017.
I am writing to inform you that, whilst undertaking the search and
retrieval process the line area have advised that it appears the scope of
your request may be too voluminous.
Currently, the search and retrieval process has revealed over 11,000 SAS
Category B medical devices and biological applications relevant to the
scope of your request.
The line area have advised that to provide the diagnosis/clinical
justification for these SAS Category B applications would require someone
sorting through over 11,000 hard copy forms to extract the information
manually. This information can however be provided for medicines
applications.
In order to reduce your scope to a size that is more manageable, you may
wish to consider revising the scope of your request to exclude
diagnosis/clinical justification for medical device and biological SAS
Category B applications.
For example, you may wish to consider submitting the following the revised
scope:
“With respect to applications to import unapproved
therapeutic goods under TGA’s Special Access Scheme between 1 January 2015
and 30 June 2017, I kindly request the following information:
Category A:
-Category
-Therapeutic Good
Category B:
-Category
-Date of Application
-Therapeutic Good
-Status
-Diagnosis Clinical Justification (for medicines only).”
We would be grateful for your response by COB Monday 28 August 2017.
Please don't hesitate to contact me if you have any questions or if you
would like to discuss this.
Kind regards
Jodie
Freedom of Information
(02) 6232 8720
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
Dear Mr Faustus
Please find attached correspondence in relation to your Freedom of
Information request.
Kind regards
Freedom of Information
(02) 6232 8720
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
Dear Madam/Sir,
I refer to your last e-mail where you advised of charges relating to my FOI request. I note that you have furnished me with an estimate of charges totaling $1,613.58.
I am a little puzzled by this.
If you read my initial FOI request dated 1 July, 2017, you will note the following:
"I trust that this request is not an onerous one and that it will not incur any processing fees. If this is not the case, please advise on possible ways that I might narrow the scope of the request."
I believe a reasonable person would interpret this to mean: "I do not wish to pay a cent. If my request will incur any costs, please tell me how I might adjust it in order to avoid such costs."
After much toing-and-froing, I thought that perhaps we were on the same wavelength.
For example, in your August 25, 2017 you advised: "I am writing to inform you that, whilst undertaking the search and retrieval process the line area have advised that it appears the scope of your request may be too voluminous."
I believe a reasonable person would interpret this to mean: "Dear faustus, I am cognisant of your wishes to not pay a cent. I think we might need to adjust the scope of your request in order to avoid such costs."
However, your e-mail quoting me a fee of $1,613.58 would suggest you have conducted yourself neither in good faith, nor in earnest.
In short: rather than quoting any amount of money payable, I wonder why it is that you did not advise: "I'm sorry, it's simply not possible for your FOI request to be processed without incurring some expenses".
In light of this, I wish to make an amendment to my original FOI request:
What information might I be able to procure for $5? I am serious: I am willing to burn a crisp fiver in this endeavour. Please advise what information I can obtain for this amount of money. Ideally, I would like it to be five dollars' worth of Special-Access-Scheme-themed-TGA-documentation-goodness, but I suspect that this would be too lofty an ambition.
If this is the case, please advise how much it will cost to obtain a black piece of paper resulting from a photocopy of a fully redacted TGA document of your choosing.
Kind Regards,
faustus
Dear Faustus
Thank you for your email of 7 September 2017.
As advised in our correspondence of 1 September 2017, under subsection 29(1) of the FOI Act you are required to notify the TGA, in writing, within 30 days (by 1 October 2017) of how you wish to proceed with your request.
Please note that if you wish to contend that the charge should be reduced or not imposed because the payment would cause you financial hardship, you believe access would be in the public interest or for any other reason, you must provide sufficient persuasive reasons to provide a basis on which the decision maker could reduce, or not impose, the fee.
Your options for proceeding with your request are:
1.) Agree to pay the charge;
2.) Request a waiver of charges, stating reasons why the charge should be reduced or not imposed; or
3.) Withdraw your request.
Please note that if a response from you is not received by 1 October 2017, the FOI Act provides under subsection 29(2) that you are taken to have withdrawn your request.
Kind regards
Freedom of Information
(02) 6232 8720
Reporting and Collaboration Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]
faustus left an annotation ()
Noting the fees quoted in previous FOI attempts, I structured my request in a manner that would obviate any fees. Yet, in spite of this approach, I was still quoted a fee exceeding $1500. Moreover, the TGA failed to respond to my amended request for a quote on "black piece of paper resulting from a photocopy of a fully redacted ... document of [TGA's] choosing." LOL... disgraceful. My intention is to re-submit my original request and argue for a fee waiver due to this information being in the public interest.