Purdue Pharma Canada Expresses Disappointment in reaction to Health Canada decision to not proceed with proposed regulations requiring tamper resistance for Oxycodone

PICKERING, ON, April 6, 2016 /CNW/ - Purdue Pharma Canada is disappointed by the decision and subsequent statement issued by Health Canada on April 4^th, 2016 to not proceed with the proposed regulations requiring tamper resistance for oxycodone.  We continue to believe products with features designed to deter misuse, abuse and diversion, can and do have a positive impact on public health, based on the abundance of published evidence.

The basis of the decision appears not to have taken into account the wealth of available published evidence and therefore, we believe that Health Canada's statement that: "Specifically, requiring tamper-resistant properties on all legitimate preparations of controlled-release oxycodone would have served to eliminate certain lower cost drugs from the market, increasing costs for patients and the health system, while having little to no effect in the fight against problematic opioid use" is fundamentally flawed. Additionally, it runs counter to the all-party consensus from the last Parliament of Canada, as well as the approach and policies of the United States Food and Drug administration (U.S. FDA).

In the last few years, both the Senate Social Affairs, Science and Technology Committee (2013) and the House of Commons Health Committee (2014) recommended that Health Canada amend the Controlled Drugs and Substances Act regulations to make abuse-deterrent products a Canadian reality. These recommendations were informed by experts from the fields of: medicine, pharmacy, public health, law enforcement, and addiction.

In contrast to Health Canada's decision, the U.S. FDA has shown public health leadership and is committed to incentivizing the development and use of ADF products as part of broader strategy to confront opioid abuse. Consequently, they have created robust scientific guidance and product labelling standards to guide and support this process. As of March 2016, the FDA has approved five ADF products and reports that more than 30 more products are at various stages of development.

Minister Philpott has a window of immediate opportunity, framed by a public health urgency, to further expand the work of the last Parliament and align with the FDA by quickly introducing regulations to accelerate the use of abuse-deterrent formulations across the entire class of opioids. We urge Minister Philpott to reconsider this decision of regulatory inaction and move swiftly to avoid any further unintended consequences to the benefit of the public safety of Canadians and our healthcare system.

ABOUT PURDUE PHARMA CANADA

Purdue Pharma Canada is a research-based pharmaceutical company with its headquarters, R&D operations, and manufacturing located in Pickering, Ontario. The company is a leader in the research and development of medicines for the treatment of pain and central nervous system disorders (ADHD) and a growing pipeline of prescription and over the counter products. Privately held, Purdue Pharma Canada is independently associated with the worldwide Purdue/Napp/Mundipharma network of companies.

For more information, please visit our website www.purdue.ca

SOURCE Purdue Pharma

FOR MEDIA / EXTERNAL INQUIRIES: Purdue Pharma Canada, Aimee Sulliman, Director of Communications, Pickering, Ontario CANADA, Tel: [phone], Email: [email protected]