Food and Drugs Act Liaison Office Releases 2015-2016 Report on Activities

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Jan 11 2017

On January 12th, the Food and Drugs Act Liaison Office (FDALO) released its 2015-2016 Report on Activities. The FDALO offers impartial and confidential dispute resolution services to stakeholders in addressing complaints, concerns or enquiries about Health Canada’s administration of the Food and Drugs Act.

Every year the FDALO prepares a report based on the cases they managed, and their observations and interactions with stakeholders. The report is intended as a feedback mechanism to stakeholders to consider options for making system-wide improvements to regulatory processes.  

Major points from the report include launching a new reconsideration process, intended as a redress mechanism within Health Canada for companies who disagree with a decision made during the drug review process. The FDALO was tasked with enhancing the impartiality and transparency of the reconsideration process and CHP Canada was consulted in 2016 on this process. This new process was in response to stakeholder complaints that the very directorate that made the decision was also running the reconsideration process.

The FDALO was also involved in contributing to the new consumer health products framework. Industry stakeholders continue to call for a new framework that aligns the regulatory approach of non-prescription drugs, natural health products, cosmetics and disinfectants, and the FDALO will be involved in helping shape that new landscape. CHP Canada will be meeting with the FDALO in early February to discuss the framework, as well as challenges we have experienced with the department during discussions on labelling.

The Strategies Committee will review the report and examine areas where Health Canada and the FDALO can improve.