Why Isnt Desoxyn Available?
Dear Advisory Committee on Prescription Medicines,
Could you please tell me why Desoyxn is not available as a treatment for ADD/ADHD in Australia?
Yours faithfully,
Mr. Benchmark
We wish to advise that the Department of Health, including the Freedom of
Information Unit, will be closed from 3pm Friday 23 December 2016 and will
resume operations on Tuesday 3 January 2017. To assist in processing your
application, please submit your application on or after 3 January 2017.
Dear Mr Benchmark,
We refer to your email of 3 January 2017 (copy below).
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.
We understand that Desoxyn is currently approved in the United States for the treatment of ADHD and exogenous obesity, and is manufactured by Recordati Rare Diseases. Further information about Recordati's products can be found at http://www.recordatirarediseases.com/pro... . You may wish to contact Recordati 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: http://www.tga.gov.au/hp/access-sas.htm .
We 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.
We hope this information assists you with your enquiry.
Kind regards,
Freedom of Information
Reporting and Collaborative Services Section
Regulatory Engagement and Planning Branch
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [email address]
Locutus Sum left an annotation ()
It is wonderful to be proved wrong by the helpful response of an agency. The agency does not exactly answer the question asked by the applicant but there is a sentence in the response that stongly implies that the manufacturer has not applied for the Desoxyn (methamphetamine hydrochloride) to be available on prescription in Australia. The sentence is "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. "
Locutus Sum left an annotation ()
This request will probably be refused because it is a request for an answer to a general question and the Australian Commonwealth Freedom of Information Act only allows requests for existing document.
To the applicant: May I please suggest that you read the annotation that I made here https://www.righttoknow.org.au/request/l... . The request of this page about Desoxyn could be rephrased to make it, for example, a request for documents regarding decisions or considerations of the Advisory Committee on Prescription Medicines. You could start by making an informal application about when (if ever) methamphetamine hydrochloride (Desoxyn) was considered by the ACPM or ACSOM committees. If it has ever been considered, then you could ask for a copy of the outcome of the meeting when the drug was discussed.