Letter to Editor regarding article "Fast-tracked new drugs more dangerous, study finds" (Toronto Star - October 8, 2012)

2012-150
October 10, 2012

OTTAWA - Health Canada's priority review policy helps deliver treatments for serious, life threatening and severely debilitating diseases to patients sooner when no other drug is available to help.  The fact that new drugs used to treat high-risk conditions are more frequently updated for new risk information is not unexpected. It is a foreseeable but manageable reflection of the complicated and serious nature of illnesses those therapies are intended to treat as well as the increased use once a drug has moved beyond clinical testing.

Contrary to the suggestion in the article, drugs reviewed under the standard and the expedited processes are reviewed under the same regulatory framework - the level of scrutiny and the rules applied remain identical.   Highly qualified scientists conduct the health-risk assessments for drugs prior to authorization and, in all cases, the evidence must clearly show that benefits of the drug outweigh the risks.  These risks and contraindications of drugs are spelled out in product monographs, which are all available on Health Canada's website. 

The Priority Review of Drug Submissions Policy is also explained clearly and publically on Health Canada's website.  In 1999, it was reviewed and amended to ensure even greater transparency and to strengthen early access to life-saving medications for Canadian patients.

After authorization, companies are required to monitor the safe use of their products.  Health Canada also continues to closely monitor drugs for any additional adverse reactions of concern that may not already have been clearly identified and labeled. 

Health Canada remains vigilant in ensuring that the balance of safety and access to new and promising therapies is maintained. As a result of priority review, potentially life-saving treatments can be made available sooner to Canadians.

Barbara J Sabourin
Director General
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada

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