Tranylcypromine Outlook

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

Dear Therapeutic Goods Administration,

Recently, phenelzine has been discontinued in Australia. In the discontinuation notice, jointly authored by RANZCP, TGA, and SHPA there is the statement:
“Stable global supply of tranylcypromine has also been difficult and this should be considered when switching antidepressants.”

Several members of the Australian MAOI community have been informed by the former supplier of phenelzine, Medsurge, that there is going to be a shortage of tranylcypromine which may begin in October 2020. We are aware Medsurge are not the supplier of Parnate, but find this, combined with the recent history of tranylcypromine shortages, and the discontinuation of phenelzine, troubling. As you are aware, the advice for patients taking phenelzine is to switch to tranylcypromine. While we understand there can be no guarantee against disruptions we would like to be as sure as possible we will not face a similar situation in a few months time.

Is TGA aware of any potential shortages or other issues relating to the supply of tranylcypromine? Please supply all relevant details, documents, and/or correspondence regarding supply details, issues, or stock levels of tranylcypromine (Parnate).

Additionally, please also provide official policies/guidelines/documents for suppliers relating to supply of medication, shortages/disruptions, and management and notifications of shortages.

Please also list any other agencies or departments which you are aware of that may hold information related to the supply, shortages, and management of prescription medication in Australia.

Yours faithfully,
Megs

TGA FOI, Therapeutic Goods Administration

4 Attachments

Dear Megs

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):

"Is TGA aware of any potential shortages or other issues relating to the
supply of tranylcypromine? Please supply all relevant details, documents,
and/or correspondence regarding supply details, issues, or stock levels of
tranylcypromine (Parnate).

Additionally, please also provide official policies/guidelines/documents
for suppliers relating to supply of medication, shortages/disruptions, and
management and notifications of shortages."

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 25 July 2020.

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 Wednesday 8 July 2020.

If you have any queries, please contact the FOI team on (02) 6289 4630, or
via email at [1][email address].

Kind regards

 

Freedom of Information

[2]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [3][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [4]www.tga.gov.au

 

[5]cid:image002.png@01D55CBC.5655D390[6]cid:image003.gif@01D55CBC.5655D390[7]cid:image004.png@01D55CBC.5655D390

 

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 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. 

 

 

 

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TGA FOI, Therapeutic Goods Administration

4 Attachments

Dear Megs

 

Thank you for your FOI request which was received by the Therapeutic Goods
Administration on 25 June 2020.

 

I am writing to seek clarification regarding the scope of your request.

 

Current scope:

                "Is TGA aware of any potential shortages or other issues
relating to the supply of tranylcypromine? Please supply all relevant
details, documents, and/or correspondence regarding supply details,
issues, or stock levels of tranylcypromine (Parnate).

 

Additionally, please also provide official policies/guidelines/documents
for suppliers relating to supply of medication, shortages/disruptions, and
management and notifications of shortages."

 

We would be grateful if you could please provide some clarity,
particularly:

-          whether you are interested in current supply or the long-term
patterns of supply. A request without a timeframe would be larger than a
request for documents from 2020. Given this, we would be grateful if you
could provide a specific timeframe for this regulatory activity; and

-          whether you are primarily interested to know about shortages.
‘Other issues relating to the supply’ might encompass issues around
quality or labelling, for example. If the key issue is whether the TGA has
been notified of shortages or have sought information from the sponsor
about supply, or have corresponded internally about the potential for
shortages of tranylcypromine, then perhaps the request could be refined to
focus on these sorts of documents.

 

The second part of your request, for guidance for suppliers about
notifying and managing shortages, relates to public information which is
available on our website at
[1]https://www.tga.gov.au/medicine-shortage...

 

It would be appreciated if we could kindly ask for your response by COB
Tuesday 7 July 2020.

 

If you have any questions, please do not hesitate to contact the FOI team.

 

Kind regards
Tara

 

Freedom of Information

[2]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [3][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [4]www.tga.gov.au

 

[5]cid:image002.png@01D55CBC.5655D390[6]cid:image003.gif@01D55CBC.5655D390[7]cid:image004.png@01D55CBC.5655D390

 

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 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. 

 

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Dear Tara,

Thanks for your email. Regarding the requested clarifications:

No personal information requested.

No duplicates requested.

Specific timeframe: October 2019 to present

Request focus – please replace this section:
"Is TGA aware of any potential shortages or other issues relating to the supply of tranylcypromine? Please supply all relevant details, documents, and/or correspondence regarding supply details, issues, or stock levels of tranylcypromine (Parnate)."

With:

Is TGA aware of any potential shortages or other issues which may negatively affect the availability of tranylcypromine?
Please supply all relevant details, documents, and/or correspondence from October 2019 to present regarding:

- Supply issues (which have affected, or have the potential to affect, the availability of tranylcypromine);
e.g. notifications and accompanied correspondence of shortages (or potential shortages); information sought from the sponsor about supply problems (possible or actual); internal and external correspondence regarding possible or actual shortages.

- Manufacturer details: specifically the manufacturer of the active pharmaceutical ingredient.

- Current (or most recently known) stock level/s of tranylcypromine (Parnate) and forecast stock levels of tranylcypromine

- Demand (e.g. factors affecting demand, such as phenelzine shortage, and data relating to demand e.g. prescriptions filled, forecast demand) for tranylcypromine

<hr>
Hope this helps focus the request.
Yours sincerely,
Megs

TGA FOI, Therapeutic Goods Administration

4 Attachments

Dear Megs

 

The TGA is currently in the process of reviewing documents following our
formal search and retrieval process for your request, FOI 1803. Due to the
need to clarify the scope of your request, it has become apparent that the
TGA may be unable to meet the current deadline for your request.

 

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. If you agree to this extension the decision on your request would
then be due on or before Monday 10 August 2020 (being the next available
business day).

 

We would be grateful if you could please respond advising whether you
agree to this extension by COB Friday 24 July 2020, if possible.

 

Thank you for your consideration of this matter.

 

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

 

Kind regards
Tara

 

Freedom of Information

Kyla | Karen | Tara | Cindy| Bradley

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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 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. 

 

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TGA FOI, Therapeutic Goods Administration

6 Attachments

Dear Megs

 

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

Cindy

 

Freedom of Information

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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 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.

 

 

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Dear TGA FOI,

I would like to contend the charges. These fees are prohibitive and would cause me financial hardship.

I believe it is in the interest of a substantial section of the public, specifically the approximate 700 Australians currently, or recently, prescribed phenelzine who have switched, or are facing a switch to Parnate due to the ongoing phenelzine supply issues.

I will supply further information and evidence regarding financial hardship via a seperate email (not through FOI website reply) with reference D20-3005042.

Yours sincerely,
Megs

TGA FOI, Therapeutic Goods Administration

4 Attachments

Dear Megs

 

Thank you for your email.

 

I acknowledge that you wish to seek a waiver of the charges a waiver of
charges on the basis of financial hardship and public interest.

 

I will inform the decision maker of your request. A decision regarding
your request for waiver of charges is due on 23 August 2020.

 

Could you please provide evidence of financial hardship as mentioned, by
Friday 31 July so that the decision maker may consider this while making
their decision.

 

Kind regards
Karen

 

Freedom of Information

Kyla | Karen | Tara | Cindy | Bradley

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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 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. 

 

show quoted sections

TGA FOI, Therapeutic Goods Administration

4 Attachments

Dear Megs

 

Could you please respond to my email below and provide evidence of
financial hardship should you wish for the decision maker to consider
this.

 

I would appreciate your response by Wednesday 5 August 2020.

 

Kind regards

Karen

 

Freedom of Information

Kyla | Karen | Tara | Cindy | Bradley

[1]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [2][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [3]www.tga.gov.au

 

[4]cid:image002.png@01D55CBC.5655D390[5]cid:image003.gif@01D55CBC.5655D390[6]cid:image004.png@01D55CBC.5655D390

 

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 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. 

 

From: TGA FOI <[email address]>
Sent: Tuesday, 28 July 2020 10:45 AM
To: Megs <[FOI #6425 email]>
Cc: TGA FOI <[email address]>
Subject: RE: FOI 1803 - Waiver of charges requested [SEC=OFFICIAL]

 

Dear Megs

 

Thank you for your email.

 

I acknowledge that you wish to seek a waiver of the charges a waiver of
charges on the basis of financial hardship and public interest.

 

I will inform the decision maker of your request. A decision regarding
your request for waiver of charges is due on 23 August 2020.

 

Could you please provide evidence of financial hardship as mentioned, by
Friday 31 July so that the decision maker may consider this while making
their decision.

 

Kind regards
Karen

 

Freedom of Information

Kyla | Karen | Tara | Cindy | Bradley

[7]cid:image001.png@01D54DDB.C1CF42E0

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [8][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [9]www.tga.gov.au

 

[10]cid:image002.png@01D55CBC.5655D390[11]cid:image003.gif@01D55CBC.5655D390[12]cid:image004.png@01D55CBC.5655D390

 

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 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. 

 

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