Letter to Apotex, Inc.

September 25, 2014

Mr. Jeremy Desai
President & CEO, Apotex Inc.

I am writing you today regarding the supply of APO-NITROGLYCERIN.

I would like to express my disappointment regarding the lack of timely notification on www.drugshortages.ca for the supply disruption of this drug product.  Health Canada was made aware earlier this week that Apotex Inc. has purportedly not been able to fulfill orders for this product in the last few months and yet only provided public notification on www.drugshortages.ca on September 23, 2014.  This apparent lack of transparency by Apotex Inc. on an issue so important to the health and safety of Canadians is unacceptable.

Early and ongoing notification and communication of reliable and comprehensive drug shortage information is critical to helping Canadians and the health care system respond appropriately, informing the timely coordination of mitigation measures, and enabling health care practitioners and their patients to make timely and well-informed decisions.  Any failure to provide this notification may put the health and safety of Canadians at risk.

Since 2011, Health Canada has repeatedly called on drug suppliers to provide public notification when they anticipate they cannot supply a drug to meet projected demand, regardless of market share.  In March, 2014, we asked drug suppliers to commit to provide notification of drug shortages and discontinuances on www.drugshortages.ca.  While Apotex Inc. did make this commitment, your recent actions fail to demonstrate your follow-through to provide timely notification.

Health Canada expects Apotex Inc. to provide timely notification of any future supply disruptions of APO-NITROGLYCERIN, and any other drug products you provide to the Canadian health care system, on www.drugshortages.ca.

Anne Lamar
A/Assistant Deputy Minister
Health Products and Food Branch

CC:
Barbara Walman, Assistant Deputy Minister, Medical Beneficiary and Pharmaceutical Services, BC Ministry of Health, and Provincial/Territorial Co-Chair of the Multi-Stakeholder Steering Committee on Drug Shortages

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