Record of Discussions - Canadian Advertising Preclearance Agencies and Health Canada - April 5, 2012

Health Products and Food Branch (HPFB)

Location: 200 Tunney's Pasture Driveway, Ottawa, Ontario

Date-Time: Tuesday, April 5, 2012 - 10:00 a.m. - 12:30 p.m.

For more information contact the Marketed Health Products Directorate's Regulatory Advertising Section.

Discussions of Health Product Advertising Issues and Topics of Mutual Interest to Canadian Advertising Preclearance Agencies and Health Canada. No policy decisions are made at these meetings. The following is a summary of the discussion between participants.

Table of Contents

• Attendees
• Opening Remarks
  • Introductions
  • Assistant Deputy Minister Address, Question Period
  • Advertising Standards Canada
• Brief Update on Outstanding Items from the 2011 Bilateral Meeting: Non-prescription Drug Label Approval Process
• Health Canada Performance Report
• Updates to the Consumer Advertising Guidelines for Marketed Health Products (Non-prescription Drugs, including Natural Health Products) and Presentation on Medical Devices
• Disclaimers in Product Monographs
• Products at the Food-Natural Health Product Interface
• Symbols used in Food and Natural Health Products Advertising that Depict Off-Label Indications
• Compliance Transparency Initiative
• Future Role of Preclearance Agencies with Respect to New Regulations
• Closing Remarks

Attendees

Canadian Advertising Preclearance Agencies Participants

• Advertising Standards Canada (ASC): Linda Nagel, CEO and President; and Nicole Bellam, Vice-President, ASC Clearance Services.
• MIJO: Anna Haine, Director, Clearance and Verification Services.
• Pharmaceutical Advertising Advisory Board (PAAB): Ray Chepesiuk, Commissioner; Walter Rosser, Chair of PAAB Board; and Patrick Massad, Chief Review Officer.

Health Canada Participants

• Assistant Deputy Minister's Office (Health Products and Food Branch (HPFB)): Paul Glover, Assistant Deputy Minister; and Karen Schwerdtfeger, Senior Policy Advisor.
• Marketed Health Products Directorate (MHPD): Chris Turner, Director General; Robert Liteplo, Acting Director, Therapeutic Effectiveness and Policy Bureau (Chair); Alain Musende, Manager, Regulatory Advertising Section; Christophe Roy, Regulatory Advertising Officer, Regulatory Advertising Section; Aline Labaki, Regulatory Advertising Officer, Regulatory Advertising Section; Lorraine Van Loon, Regulatory Advertising Officer, Regulatory Advertising Section; and Dipankar Chakravarty, Regulatory Advertising Officer, Regulatory Advertising Section.
• Therapeutic Products Directorate (TPD): Daniel Yoon, Regulatory Information Officer, Medical Devices Bureau; and Bruce Boulton, Product Information Officer, Bureau of Gastroenterology, Infectious and Viral Diseases
• Policy, Planning and International Affairs Directorate (PPIAD): Monica Dhir, Senior Legal Analyst, Office of Legislative and Regulatory Modernization.
• Natural Health Products Directorate (NHPD): Christine Gillis, Acting Director, Bureau of Policy and Risk Management; and Eva Klassen, Acting Head, Bureau of Product Review and Assessment.
• Health Products and Food Branch Inspectorate (HPFBI): Kim Dayman-Rutkus, Director, Policy and Strategic Planning Division; and Ian Grimwood, Acting Manager, Drug Compliance Verification and Investigation Unit.
• Food Directorate: Michael Masotti, Senior Issues Manager, Director General's Office; and Eunice Chao, Nutrition Labelling and Health Claims, Bureau of Nutritional Sciences.

Opening Remarks

Introductions

The Chair welcomed attendees and noted that the meeting is a chance to exchange information and to have thoughtful discussions on health product advertising, but is not a decision-making forum.

Assistant Deputy Minister Address, Question Period

The Assistant Deputy Minister (ADM) welcomed attendees and reiterated Health Canada's mandate. He emphasized operational excellence and performance objectives; modernization and transparency.

Advertising Standards Canada - Research Highlights

Advertising Standards Canada (ASC) presented the results of a consumer research they carried out with regard to the public's impression on advertising and standards for advertising, from the perspective of Canadian and American adults.

Brief Update on Outstanding Items from the 2011 Bilateral Meeting: Non-prescription Drug Label Approval Process

Issue(s):

• An outstanding item from last year's bilateral meeting was addressed and participants were updated on its current status.

Discussion Highlights:

• Since the last bilateral meeting, Health Canada has started scanning in marketed labels for non-prescription drug products into its Drug Product Database (DPD) and these are currently accessible internally only.
• Health Canada continues to work on having these marketed labels in the DPD; and accessible to the general public in the future, similar to the Product Monograph (PM).
• The Therapeutic Products Directorate (TPD) is still exploring ways to facilitate comparison of marketed labels with approved labels.

Action(s):

• Health Canada will provide further updates at the next bilateral meeting in 2013.

Health Canada Performance Reporting

Issue(s):

• Health Canada annually provides a statistical report of advertising activities.

Discussion Highlights:

• The Annual Statistical Report of Regulatory Advertising Activities (complaints and requests for clarification) for Fiscal Year 2011-2012 was shared with the participants.
• A performance standard was established by the Regulatory Advertising Section for responding to complaints and requests for clarification, in which 90% of the requests are actioned within the first 15 days.
• Response times are improving year after year.

Action(s):

• Greater reporting and tracking initiatives will be considered in order to have a more accurate and systematic process between the Health Products and Food Branch Inspectorate (HPFBI) and the Marketed Health Products Directorate (MHPD).

Updates to the Consumer Advertising Guidelines for Marketed Health Products (Non-prescription Drugs, including Natural Health Products) and Presentation of Medical Devices

Issue(s):

• The Consumer Advertising Guidelines for Marketed Health Products: Non-prescription Drugs including Natural Health Products (CAG) will be updated to include advertising of vaccines and medical devices.

Discussion Highlights:

• The lead on Medical Device advertising has been transferred to MHPD, from the HPFBI.
• Work on the CAG is currently progressing and internal discussions are ongoing with regard to including guidelines for medical device advertising in the guidance document.
• At the moment, MHPD is in the process of gaining a better understanding of the unique regulatory characteristics of medical device advertising.
• MHPD intends to forward a copy of the revised CAG to the advertising preclearance agencies for initial feedback and discussion in August 2012.
• The CAG will be subject to a broader external stakeholder consultation in September 2012.
• Issuance of the updated CAG is anticipated for February 2013.
• A representative from the Medical Devices Bureau briefly described and presented relevant information about the different types of medical devices, the submission requirements and necessary supporting evidence for which the terms of market authorization are granted upon.

Action(s):

• None

Disclaimers in Product Monograph

Issue(s):

• The Pharmaceutical Advertising Advisory Board (PAAB) requested that a disclaimer be included in the Product Monograph when a drug has an indication approved on evidence involving only surrogate markers but had no proven effect on morbidity and mortality.

Discussion Highlights:

• TPD explained that disclaimers are still occasionally used in Product Monographs as they may provide a better understanding in certain circumstances.
• Lists of non-indications clutter the text of the Product Monograph and may contribute to confusion and be incorrectly recalled later by a prescriber as an actual indication.
• Product Monographs are generally very clear and written with positive statements.
• Non-indications are still found in many Product Monographs and will continue to be added, based on an individual assessment.
• The PAAB believes the suggestion may have merit due to international movement to recognize outcomes as more important in clinical decisions than mere surrogate marker measurement.
• It is of the opinion of the PAAB that it is important that TPD use specific and appropriate wording of the disclaimers.

Action(s):

• TPD will examine this issue further when undertaking revisions to the Product Monograph.

Products at the Food-Natural Health Product Interface

Issue(s):

• ASC requested clarity on issues and transition timeframes pertaining to products at the Food-Natural Health Product (NHP) interface.

Discussion Highlights:

• The oversight of caffeinated energy drinks are in the process of transitioning from the Natural Health Products Directorate (NHPD) to the Food Directorate.
• The Food Directorate has finalized a guidance document for energy drinks that is posted on Health Canada's Web site and anticipates adding a table showing all energy drinks that have received a Temporary Marketing Authorization (TMA) Letter.
• The transitioning of the remaining products at the Food-NHP interface will continue with the classification of products currently on the market.
• Final date for all products to transition to the Food Directorate is December 2012.

Action(s):

• None

Symbols used in Food and Natural Health Product Advertisements that Depict Off-Label Indications

Issue(s):

• PAAB raised the issue that health product advertising that includes graphics such as a heart logo needs to have an accompanying claim for efficacy approved by Health Canada.

Discussion Highlights:

• MHPD recognizes the need for consistency amongst all health product lines. MHPD will be consulting internally across the Branch and will be adding a section in the Consumer Advertising Guidelines accordingly.
• The Food Directorate explained that currently health claims related to heart disease can be made on food under certain conditions.

Action(s):

• Internal consultations to take place across the Branch before a decision is made on the use of graphics, such as a heart logo, in health product advertising for all health product lines.

Compliance Transparency Initiative

Issue(s):

• ASC requested an update on the compliance transparency initiative which is intended to provide greater transparency with respect to compliance work via Health Canada's web site.

Discussion Highlights:

• To meet Health Canada's objective of increasing transparency to Canadians, the HPFB is currently exploring the option of posting advertising complaint decisions on the Health Canada Web site.

Action(s):

• None

Future Role of Preclearance Agencies with Respect to New Regulations

Issue(s):

• PAAB enquired about the future role of preclearance agencies and the need for the PAAB complaint resolution mechanism.

Discussion Highlights:

• A broad discussion on advertising took place at the Technical Discussions on Modernizing the Food and Drug Regulations for Drugs and Medical Devices.
• Feedback from the discussion is being reviewed by Health Canada and will be considered in developing regulatory proposals.
• Health Canada will continue with stakeholder consultations moving forward.

Action(s):

• None

Closing Remarks

Health Canada thanked participants for the valuable discussion and input.