Health Canada released the Draft Revised Guidance Document for Industry ̶ Review of Drug Names for Look-alike Sound-alike Attributes (the Guidance) in early 2013.1 The Guidance seeks to clarify the process to be followed and information to be submitted to Health Canada for drug name approval, with the ultimate goal of reducing medication errors resulting from name confusion. While it was expected that the Guidance would be finalized by early 2014, we understand that a new version of the Guidance is expected for release in mid-2014.
Under the current draft of the Guidance, drug sponsors need to give Health Canada significantly more detailed information about the potential for a proposed drug name to be confused with another product authorized for use in Canada.
The current draft of the Guidance builds on Health Canada’s guidance document currently in place2 , and seeks to address the inconsistencies in the quality and type of evidence submitted by sponsors. While the guidance currently in place offers suggestions as to what a sponsor’s submission can include without clear direction, Health Canada is now seeking objective information in a standardized format. Under the 2013 Guidance, a sponsor must implement a three-step "search, simulate and synthesize" approach to its assessment of the potential for brand name confusion. The three steps are described below.
- Search. The sponsor is expected to conduct an extensive search for similar drug names, using search engines and databases, and identify the most similar names based on specific algorithmic similarity scores.3 The sponsor is also expected to search published literature and provide any reports of foreign regulators regarding the name.
- Simulate. The sponsor is expected to conduct experiments to test the confusability of the brand name in auditory/visual perception and memory tasks (psycholinguistic testing) and to simulate each stage of the medication-use process to assess confusability.
- Synthesize. The sponsor is expected to combine results from the Search and Simulate phases, put the brand name through a failure mode and effects analysis (FMEA) to further identify any problems, and submit its final rationale for approval of the name.
Health Canada will conduct an initial brand name review in which the name will be subjected to specific threshold questions. If the proposed drug name survives the initial brand name review, Health Canada will review the sponsor’s assessment in detail, conduct its own reviews, and request further information if necessary to assess whether the proposed name is likely to cause confusion with other health products, or is misleading with respect to therapeutic effectiveness, composition or safety.
If the drug name is accepted, Health Canada can issue a drug identification number (DIN) and/or a Notice of Compliance (NOC). If the drug name is rejected, Health Canada can refuse to issue a DIN or NOC, and the sponsor is left with the options of submitting an alternative name, proceeding with the proper name or common name alone, or appealing the decision through a Request for Reconsideration to Health Canada.
The goal of the Guidance is to make the drug name review process as a whole more transparent. The result, however, is a substantial and onerous set of requirements that increases the sponsor’s burden significantly. Sponsors should expect an increase in the cost and time required to prepare assessments, and should also expect increased rejections of proposed brand names.
The Guidance has prompted stakeholder concerns about the onerous obligations of the sponsor assessment process and inconsistencies with requirements in foreign jurisdictions. While the next version of the Guidance is expected to address some of these stakeholder concerns, we anticipate that the finalized Guidance will ultimately represent a more stringent approval process in Canada.
2 See Guidance for Industry – Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names, January 1, 2006, available at www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/drugs-drogues/lasa_premkt-noms_semblables_precomm-eng.php.
3 The scores will be based on the ALINE algorithm, which is also used by the U.S. Food and Drug Administration in its Phonetic and Orthographic Computer Analysis (POCA) software.
To discuss these issues, please contact the author(s).
This publication is a general discussion of certain legal and related developments and should not be relied upon as legal advice. If you require legal advice, we would be pleased to discuss the issues in this publication with you, in the context of your particular circumstances.
For permission to republish this or any other publication, contact Janelle Weed.
© 2021 by Torys LLP.
All rights reserved.