PAAB Guidance on Social Media Marketing for Pharmaceuticals
May 25, 2011
Authors: Jennifer McKenzie and Ainslie Parsons
Social media marketing may be used to promote pharmaceuticals in Canada. However, any social media marketing program must be carefully set up and monitored to ensure that it complies with the Canadian regulatory regime.
The Pharmaceutical Advertising Advisory Board (PAAB) is a review agency that ensures that Canadian drug advertising directed to health care professionals falls within Canada’s regulatory regime. PAAB also assists pharmaceutical companies to ensure their direct-to-consumer messages are onside. In November 2010, Patrick Massad, the Chief Review Officer at PAAB, gave a talk at an eMarketing Canada conference in Toronto entitled “PAAB Guidance on Social Media Marketing” (“PAAB Guidance”). Slides from the talk are available on the PAAB website.
Various laws, regulations and guidelines apply to all Canadian pharmaceutical ads (for example, the Food & Drugs Act and Regulations, Health Canada Guidelines, the PAAB Code of Advertising Acceptance and the Rx&D Code of Ethical Practices). In particular, ads for Schedule F drugs (prescription drugs) directed to the “general public” may only state the drug name, price and quantity; no therapeutic claims can be made. Direct-to-consumer messages which merely inform the consumer about a condition and direct the consumer to speak with their physician about available treatments (without naming any one treatment) are not considered to be advertising.
The PAAB Guidance emphasizes that Health Canada’s existing advertising regulations apply to social media marketing of pharmaceuticals. There is no indication from Health Canada that they have any current plans to introduce regulatory changes aimed at social media marketing.
The following specific issues related to social media are covered in the PAAB Guidance:
Once a website is determined to be advertising, the site in its entirety, including any user-generated content, is subject to regulatory control. In other words, a sponsor has responsibility for any user-generated content posted on their website. To this end, social media may need to be closely monitored and moderated by the sponsor. For example, user-generated content on an “informational site” which would not normally be considered to be advertising could render the site promotional. Similarly, an advertising site for a prescription drug could be rendered non-compliant with the Food & Drugs Act if user-generated content reveals more than simply the name, price and quantity of the drug.
Barriers to entry
Websites can be “gated” to ensure that only the appropriate parties obtain access to particular information. For example, an online discussion group relating to the use of a certain drug can be restricted to patients who have been prescribed the drug (patients are not considered to be members of the “general public” and, therefore, the same restrictions do not apply and a drug can be linked to its therapeutic use). Often this is accomplished by requiring a user to enter the drug’s DIN to gain access. Online access can also be controlled by distributing “keys” that bypass the barrier to the targeted audience or by requiring a moderator to verify the user’s identity. A simple “attestation” such as the confirmation from a user that they have been prescribed the product is not considered to be a sufficient barrier to entry. Note also that any non-gated sections of a gated website will be subject to the regular consumer regulations.
Reporting adverse reactions
According to the PAAB Guidance, a manufacturer should screen websites under its control for potential case reports. A manufacturer is not necessarily obligated to screen external websites, however, if a manufacturer becomes aware of an adverse reaction on a website that it does not manage, the manufacturer should review the case and determine whether it should be reported.
Once an ad is “linked” to a non-ad, the non-ad becomes an ad and must comply with the regulations. For example, an online Continuing Medical Education program that contains a link to a pharmaceutical ad becomes an ad itself and must comply with the regulations. As such, manufacturers need to be wary of what is linked to and from their websites.
Sponsored links and keywords
Sponsored link ads and the corresponding keywords are subject to review by PAAB. For example, with respect to a website about a Schedule F drug, the aggregate of any purchased keywords, sponsored links and the landing page and its URL must not go beyond the name/price/quantity restriction. Likewise, with respect to a website about a disease, any purchased keywords, sponsored links and the landing page and its URL must not contain the drug name. These regulations do not apply to organic keywords (i.e., keywords that have not been purchased).
Content shared on Bereskin & Parr’s website is for information purposes only. It should not be taken as legal or professional advice. To obtain such advice, please contact a Bereskin & Parr LLP professional. We will be pleased to help you.