Record of Discussions - Canadian Advertising Preclearance Agencies and Health Canada - April 19, 2011

Health Products and Food Branch (HPFB)

Location: 200 Tunney's Pasture Driveway, Ottawa, Ontario
Date-Time: Tuesday, April 19, 2011 - 9:30 a.m. - 12:30 p.m.

For more information contact the Marketed Health Products Directorate's Regulatory Advertising and Risk Communications 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 discussions between participants.

Table of Contents    

• Attendees
• Opening Remarks
• Brief Update on Outstanding Items from the 2010 Bilateral Meeting - Consumer Advertising Guidelines (CAG)
• Health Canada Performance Report
• Complainant's Identity and Transparency
• Guidance for Advertising of Natural Health Products (NHPs) in Food Format
• Non-prescription Drug Label Approval Process
• Compliance with Section 2.21 of the Consumer Advertising Guidelines
• Advertising Standards Canada Recent Consumer Research
• Advertising Regulations for Natural Health Products
• Future Role of Advertising Preclearance Agencies with respect to Regulatory Modernization
• Query for New Guidance Document on Social Media Marketing
• Disguised Advertising
• Branded Prescription Drug Web Site including Physician Information
• Closing Remarks  

Attendees 

Canadian Advertising Preclearance Agencies Participants

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

Health Canada Participants

• Marketed Health Products Directorate (MHPD): Dr. Chris Turner, Director General, Robert Liteplo, Acting Director, Therapeutic Effectiveness and Policy Bureau (Chair), Ann Sztuke-Fournier, Manager, Regulatory Advertising and Risk Communications Section, Alain Musende, Head, Regulatory Advertising Unit, Christophe Roy, Regulatory Advertising Officer, Regulatory Advertising Unit, Anne MacIsaac, Regulatory Advertising Officer, Regulatory Advertising Unit, Judy Allaire, Regulatory Advertising Officer, Regulatory Advertising Unit, Aline Labaki, Regulatory Advertising Officer, Regulatory Advertising Unit.
• Therapeutic Products Directorate (TPD): Alima Tapsoba, Product Information Officer, Bureau of Gastroenterology, Infection and Viral Diseases.
• Policy, Planning and International Affairs Directorate (PPIAD): Monica Dhir, A/Senior Legal Analyst, Office of Legislative and Regulatory Modernization, David K. Lee, Director, Office of Legislative and Regulatory Modernization.
• Natural Health Products Directorate (NHPD): Patrice Milord, Senior Policy Analyst, Bureau of Policy and Risk Management.
• Health Products and Food Branch Inspectorate (HPFBI): Ian Grimwood, A/Manager, Drug Compliance Verification and Investigation Unit.

Opening Remarks   

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. 

Brief Update on Outstanding Items from the 2010 Bilateral Meeting - Consumer Advertising Guidelines (CAG)

Issue(s):

• Outstanding items from last year's bilateral meeting were addressed and participants were updated on their current status. 

Discussion Highlights:

• Since the last bilateral meeting, Health Canada has issued the following documents related to Health Product advertising:
  • Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising guidance document
  • Schedule A/Section 3 to the Food and Drugs Act guidance document
  • Position Statement on the Preclearance and Complaint Adjudication of Exempted Natural Health Product Advertising Materials.
• Revisions to the Consumer Advertising Guidelines in 2011 will reflect these updates.

Action(s): 

• Update Consumer Advertising Guidelines.

Health Canada Performance Report

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 clarifications) for Fiscal Year 2010-2011 was shared with the participants. 
• Response times are improving year after year.

Action(s): 

• None

Complainant's Identity and Transparency

Issue(s): 

• HPFBI's processes require obtaining permission to reveal a complainant's identity when referring a complaint to an advertising preclearance agency. This makes it difficult for ASC to comply with its policy of blinding the identity of consumer complainants only.
• A complaint handling mechanism respecting ASC and the HPFBI's procedures should be implemented.

Discussion Highlights:

• The guidance document Health Canada and Advertising Preclearance Agencies' Roles Related to Health Product Advertising requires that Health Canada seek consent from complainants to disclose their identity to the advertising preclearance agency.

Action(s): 

• The HPFBI will look to change their processes such that complainants who do not permit Health Canada to disclose their identity will be asked to contact the advertising preclearance agencies directly to submit their complaints.

Guidance for Advertising of Natural Health Products (NHPs) in a Food Format

Issue(s):

• NHPs in food formats resemble and are sold next to foods, posing advertising challenges.
• NHP Companies are adding food-type claims on the labels of NHPs in food formats and making comparisons to foods in advertising.
• To ensure clarity among all stakeholders, ASC recommended the convening of interested stakeholders and representatives from Health Canada's food and drug directorates to review and discuss this issue. 

Discussion Highlights:

• NHPD recognizes that this is an issue amongst others, with respect to this category of products; however it is not an NHPD-specific issue but rather a branch one.
• A clear and consistent approach to classification, labelling and advertising of these products is needed.
• The Health Products and Food Branch is reviewing the classification of NHPs in food formats with the intent of finding the most appropriate regulatory framework for these products.

Action(s): 

• Advertising guidelines may need to be updated once an approach to classification and labelling of these products has been decided upon.

Non-prescription Drug Label Approval Process

Issue(s): 

• ASC sought clarification on whether TPD reviews/authorizes final product labels.

Discussion Highlights: 

• As part of its drug review process, TPD confirmed that the submitted draft labels (text) are reviewed with respect to the Food and Drug Regulations, the relevant Labelling Standards and/or Category IV Monographs, and other applicable Health Canada guidelines.
• The sponsor has a responsibility to submit the final label to the Submission and Information Policy Division within 30 days of marketing their drug product in Canada.  Final marketed labels may be filed without being compared to prior approved labels. 

Action(s): 

• In an attempt to have information on the final marketed labels respect the Terms of Market Authorization for the drug product and not contravene the Food and Drugs Act and Regulations, TPD is exploring ways to facilitate comparison of marketed labels with approved labels.

Compliance with Section 2.21 of the Consumer Advertising Guidelines 

Issue(s):

• ASC wished to update participants on Consumer Health Products Canada's voluntary guideline to increase readability of cautionary statements in consumer drug advertising.

Discussion Highlights: 

• ASC provided the update.
• Health Canada acknowledges that there is improvement; however, more needs to be done to provide evidence of the effectiveness of communicating risk information.

Action(s): 

• To consider for updates to the Consumer Advertising Guidelines in 2011.

Advertising Standards Canada (ASC) Recent Consumer Research

Issue(s):

• ASC requested to present recent consumer research regarding its new advertising campaign.

Discussion Highlights:

• ASC presented its multimedia advertising campaign.

Action(s):

• None

Advertising Regulations for Natural Health Products  

Issue(s):

• The PAAB enquired about why Technical Discussions on Regulatory Modernization, hosted by Health Canada in January 2011, did not address advertising of NHPs. 

Discussion Highlights:

• The Technical Discussions focussed on the outdated regulatory framework for drugs, not newer regulatory frameworks such as the Natural Health Product Regulations. 

Action(s):

• None

Future Role of Advertising Preclearance Agencies with respect to Regulatory Modernization

Issue(s):

• The PAAB enquired about the role of preclearance agencies when new regulations are promulgated.

Discussion Highlights:

• Regulatory modernization should supplement, not replace, the preclearance system. Stakeholders will continue to be consulted as regulatory modernization proceeds.

Action(s):

• None

Query for New Guidance Document on Social Media Marketing

Issue(s):

• The PAAB asked whether Health Canada plans to issue a guidance document on health product advertising in social media.

Discussion Highlights:

• Health Canada is not currently developing guidance documents for social media advertising. Existing regulatory advertising provisions apply indiscriminately to all media.
• Health Canada has provided guidance on the use of social media to various stakeholders, and participated in PAAB's 2009 workshops on Social Media Marketing.

Action(s):

• Health Canada will provide input when PAAB revises its Code to reflect social media.
• To consider adding statements in Health Canada documents to inform stakeholders that advertising provisions apply to all media.

Disguised Advertising

Issue(s):

• Health Canada shared case examples to promote consistency in handling advertising disguised as information.

Discussion Highlights:

• Section 9(1) of the Food and Drugs Act prohibits false and misleading advertising, and can apply when the public is misled to believe an advertisement is objective information.
• Examples of past complaints include "special information supplements" in newspapers and "press releases on corporate Web sites".

Action(s):

• For consideration by advertising preclearance agencies when providing advisory opinions.

Branded Prescription Drug Web Sites including Physician Information

Issue(s):

• Some Industry branded Web sites link to medical clinic Web sites with prescription drug advertising which contravenes Section C.01.044 of the Food and Drug Regulations.

Discussion Highlights:

• Consumer directed advertising of prescription drugs on physician clinic Web sites is widespread in certain specialties. It often exceeds the name, price, and quantity limitations of Section C.01.044.
• Health Canada contacted the provincial and territorial medical licensing bodies to enlist their help to educate physicians about federal advertising regulations for prescription drugs.

Action(s):

• None.

Closing Remarks    

Health Canada thanked participants for the valuable discussion and input.