Notice

Our file number: 06-122386-648

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Contact: SAP Drugs

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October 2, 2006

Administration of the Special Access Programme with respect to 714-X: Decision of the Federal Court, Trial Division of July 28, 2006

A decision was issued by the Federal Court, Trial Division, in July 2006 in relation to special access to the drug known as 714 -X under Health Canada's Special Access Programme (SAP). That court decision, while upholding the practices and authorities of the Special Access Programme, directed Health Canada to balance access to unproven drugs and the compassionate or humanitarian aspects of an illness when conventional treatments have proven ineffective or inadequate. Health Canada will follow the direction provided by the Court as to the administration of the Special Access Programme with respect to 714-X.

Although 714-X has never been the subject of a clinical trial , a formal drug development plan or granted market authorization by a credible and competent regulatory agency, 714-X has a history of past authorizations through SAP which resulted in a considerable number of patient exposures. Given these facts, Health Canada will now consider SAP requests on a case-by-case basis and without regard to the letter issued by it on January 23, 2004 which was invalidated by the court. That letter indicated, amongst other things, that it was unlikely that the SAP would authorize the sale of 714-X for new patients. Health Canada will now consider any request for 714-X regardless of whether a patient is new or repeat.

Health Canada expects that physicians will consider the information contained in the Annex to this notice when they contemplate applying for SAP authorization for 714-X; when they seek and document their patients' informed consent to treatment; and when they administer the drug.

In light of the limited data available with respect to the use of this drug, careful application of the requirements of the Food and Drug Regulations is required. First, section C. 08.010 (1)(a)(ii) requires practitioners to supply the data in their possession with respect to the use, safety and efficacy of the drug. Second, section C.08.010(1)(b)(i) requires practitioners to report to the manufacturer and to Health Canada about the use of the drug including information respecting any adverse events encountered. Regular reports of individual patient experience, including any reports of adverse events, will be important for determining the appropriateness of continued therapy.

This notice is intended to provide general guidance to the public and health care professionals regarding the Department's current interpretation of the SAP in relation to 714-X based on information currently known to the Department about 714-X. It is an administrative instrument that does not have the force of law, is not binding and allows for flexibility in approach. It provides guidance that is specific to 714-X and is based on the facts associated with that drug. As such, it cannot be interpreted as applicable to other drugs that do not have credible clinical trial evidence, or the history of past authorizations and resulting patient exposures that 714-X had. Health Canada will continue to consider humanitarian or compassionate factors in its general administration of the SAP.

For more information on the SAP or the content of the notice, please contact the SAP at (613) 941-2108.

Annex: 714-X

The chemical composition of 714-X is specified in the technical data available from its manufacturer, Centre Experimental de Recherches Biologiques de L'Estrie Inc. In 1990, Health Canada analysed a sample of the product and confirmed the presence of camphor, ammonium chloride, sodium chloride, ethanol, water and ammonium nitrate.

Health Canada is not familiar with the method of manufacture of 714-X and cannot confirm whether the drug or the facility in which it is manufactured conforms to any accepted standard of manufacture such as Good Manufacturing Practices for injectable products. Adherence to such standards normally requires modern facilities, expert training and rigorous quality assurance protocols. The absence of such confirmation is important information for both physicians contemplating prescribing the drug and patients considering its use.

The manufacturer recommends injection of 714-X into the inguinal lymph nodes. There are well known risks associated with all needle injections, which in general require medical supervision. Intra-nodal injections in particular are rare and require expert palpation and guidance. Given these risks and the proximity of the femoral artery, nerves and other tissue in the inguinal region, Health Canada strongly recommends that injections of 714-X be administered by physicians using appropriate technique to mitigate these risks.

Multiple reviews of the medical literature, web sites and other sources of information show that 714-X has never been the subject of a clinical trial, a formal drug development plan or granted market authorization by a credible and competent regulatory agency. No non-clinical studies on 714-X have been published in peer-reviewed scientific literature.

It is Health Canada's expectation that practitioners seeking access to 714-X give consideration to the individual circumstances of their patients and take the necessary steps to ensure that patients are fully informed of the information available respecting 714-X and that such informed consent is well documented.