Dear Mr Smith,

I refer to your email of 8 March 2014 addressed to the ACPM Secretariat
(below).

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 FOI 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.  
 
Also, for your information, the Therapeutic Goods Administration (TGA) is
the agency responsible for the regulation of therapeutic goods in
Australia.  It is a general requirement under the Therapeutic Goods Act
1989 (the Act) that medical products to be imported into, supplied in, or
exported from Australia be included in the Australian Register of
Therapeutic Goods (ARTG).  Currently, Desoxyn is not included on the ARTG.

In order for a prescription medicine to be included in the ARTG, a sponsor
is required to submit an application accompanied by scientific data to
support the quality, safety and efficacy of the product for its intended
use.  The Government is not able to compel a sponsor to submit an
application to register a medicine in Australia and approval for marketing
cannot be given in the absence of an application.  Should a sponsor submit
an application, the TGA will evaluate the product for its intended use
before making a decision to approve or reject the product for marketing in
Australia.

I understand that Desoxyn is currently approved in the United States for
the treatment of ADHD and exogenous obesity, and is manufactured by
Ovation Pharmaceuticals.  You may wish to contact Ovation Pharmaceuticals
to ask about their intentions in relation to the supply of Desoxyn in
Australia.

Recognising that for various reasons there are times when approved and
available products may not meet the needs of all patients, you may be
interested to know there are provisions under the Act where doctors and
patients may obtain access to unregistered medicines where such use is
medically required.  These provisions include supply of a medicine under
the Special Access Scheme (SAS).  The SAS provides a lawful avenue of
access to products not freely marketed in Australia.  Further information
about the SAS may be found at:
 [1]http://www.tga.gov.au/hp/access-sas.htm.

The TGA would encourage patients to discuss treatment options with their
doctor, who would be familiar with the workings of the SAS, and would be
best suited to provide advice on appropriate treatment options, taking
into account the particular circumstances of an individual patient.
 
Please don't hesitate to contact me should you have any further questions
regarding an FOI request.

Kind regards
Liz

Freedom of Information
Liz Santolin 02 6232 8664
Sebastian Antezana 02 6232 8163
Karen Bedford 02 6232 8772
Brooke Massari 02 6232 8153
Emily May 02 6232 8792

Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]

From:        Jared Smith <[FOI #556 email]>
To:        FOI requests at Advisory Committee on Prescription Medicines
<[email address]>,
Date:        08/03/2014 07:07 PM
Subject:        Freedom of Information request - Why Isnt Desoxyn
Available ?

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Dear Advisory Committee on Prescription Medicines,

Could you please tell me why Desoyxn is not available as a treatment for
ADD/ADHD in Australia?  I have read numerous studies from overseas showing
that Desoxyn in some cases can be a far superior treatment that
Dexamphetamine or Ritalin Methylphenidate.  I personally think that all
treatment options should be available in Australia, and not just excluded
due to a particular drug being know for substance abuse.

Yours faithfully,

Jared Smith

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References

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