Letter to Mylan Pharmaceuticals, ULC

September 25, 2014

Mr. Richard Guest
President, Mylan Pharmaceuticals, ULC

I am writing concerning the supply of Mylan Nitro Sublingual Spray.

It is Health Canada's expectation that drug suppliers provide stakeholders with the earliest possible information on all manufacturing disruptions that have resulted in an actual supply disruption, might lead to shortages or otherwise affect the availability of drugs and negatively impact patient care.  Health Canada was only notified of this situation on Friday, September 19, 2014, although we understand that Mylan Pharmaceuticals Inc. has been actively trying to mitigate a potential supply disruption since early September.

Canada's multi-stakeholder approach to drug shortages is premised on the principle that Canada's healthcare system, and the patients served by it, requires advance notification of supply disruptions to adjust to shortages and implement mitigation measures to minimize their impact on patient care.  Failure to provide this notification in a timely, comprehensive, and reliable manner 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 current or projected demand.   In March, 2014, we asked drug suppliers to commit to provide notification of drug shortages and discontinuances on www.drugshortages.ca.  While Mylan Pharmaceuticals ULC did make this commitment, your recent actions fail to demonstrate your follow-through to provide notification.

Health Canada expects Mylan Pharmaceuticals ULC to provide timely notification of any future supply disruptions of Mylan Nitro Sublingual Spray, 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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