Decision relating to Apotex, manufacturer of generic medications.
Tim Senior 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 Therapeutic Goods Administration,
I wish to submit a Freedom of Interest request regarding a recent investigation of Apotex, a manufacturer of generic medicines based in India. I gather that a joint inspection of the manufacturer was made with Canadian authorities. As a result of safety concerns, the US and Canadian regulatory authorities have banned this manufacturer from their markets. The reasons for their decisions are available on their websites.
I understand that the TGA have made a different decision to the US and Canadian authorities, but there is no information published on the reasons a different decision was made.
It is clearly in the public interest to have the reasons for the TGA decision relating to Apotex made public, especially when the findings from overseas authorities are already in the public domain.
I therefore request documents, briefings, notes and correspondence relating to the visit to Apotex with Canadian authorities in August 2014, the findings and subsequent decisions, including requirements and compliance measures for Apotex.
Yours faithfully,
Tim Senior
Dear Dr Senior
Please see attached correspondence in relation to your FOI request to the
Department of Health.
Kind regards
FOI Officer
Information Law Section| Legal Services Branch
Department of Health
Phone: (02) 6289 1718
GPO Box 9848, Canberra ACT 2601 | MDP 350
Dear Mr Senior
Please find attached correspondence relating to your Freedom of
Information request 087-1415.
Kind regards
Emily
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Heather Kerr 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
[2]cid:image003.gif@01CFA69C.488B9550
References
Visible links
1. mailto:[email address]
Dear Mr Senior,
Please find attached correspondence relating to your Freedom of
Information Request 087-1415 received 27 October 2014.
Kind regards
Emily
Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792
Anna Theodore 02 6232 8163
Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]
References
Visible links
1. mailto:[email address]
Tim Senior left an annotation ()
Some background on this request.
Kistof Wing (@Yunadal on Twitter) first alerted me to this issue. There was a background report here http://www.news.com.au/national/us-drug-...
The US and Canadian responses warning letters have been published online
2009: http://www.fda.gov/iceci/enforcementacti...
2013: http://www.fda.gov/iceci/enforcementacti...
2014: http://www.fda.gov/iceci/enforcementacti...
The drugs manufactured by Apotex are listed here: https://www.apotex.com/au/en/products/se...
That's a wide range of medications used in Australia, and safety concerns should be taken seriously.