With respect to the regulatory requirements for off-label use of a medical device and the special access program: (a) what are the federal regulations that control off-label use of a medical device already approved in Canada; (b) when a device such as a "stent" is proposed to be used by a licensed Canadian surgeon or interventional radiologist for the treatment of a medical condition not originally approved by the Medical Devices Bureau, (i) is there a requirement for a separate set of clinical trials or does such use fall under provincial jurisdiction and their practice of medicine guidelines, (ii) and if off-label use falls under provincial jurisdiction, why did the federal government intervene regarding the new procedure for chronic cerebrospinal venous insufficiency (CCSVI); (c) what are the regulatory requirements for the special access program that allows practitioners to request access to drugs or devices that are not currently approved for use in Canada for patients with serious or life threatening conditions, (i) why did the procedure for chronic CCSVI fail to meet the specified requirements on a compassionate or emergency basis when conventional therapies have failed, are unsuitable, or are unavailable, (ii) how did kidney denervation meet the specified requirements; (d) how many CCSVI procedures worldwide have been performed to date, (i) how many positive and negative peer-reviewed CCSVI studies have been published to date, (ii) how many Canadians are estimated to have had the procedure for CCSVI since January 2010, and how many of them have been followed to date, (iii) how many phase II and phase III clinical trials for CCSVI are currently underway internationally, (iv) in light of the safety findings reported on 1375 patients studied in eight recently published clinical trials on CCSVI, why is Canada beginning with a phase I study; and (e) how many procedures worldwide have been performed for kidney denervation, (i) how many positive and negative peer reviewed studies have been published to date, (ii) had the procedure been assessed through a double-blind trial with a placebo group when the procedure was approved in Canada, (iii) how many safety studies have been published to date, and what is the complication rate, (iv) what phase clinical trials are currently underway internationally, (v) will Canada be undertaking phased clinical trials?
In the House of Commons on September 17th, 2012. See this statement in context.