The Pharmaceutical Advertising Advisory Board (PAAB) recently held 3 sessions of a workshop called “Social Media Marketing in Pharma: What Works in Canada”. Originally, only one session in each Montreal (September 29 2009) and Toronto (September 30 2009) was planned, but due to popular demand, a 3rd session took place in Toronto this week (November 9 2009). In total, there were 250 Canadian pharma marketers (client and agency side) who registered for these sessions.
The panel members for this workshop are listed below. I was quite humbled to be included as part of this stellar cast;
Ray Chepesiuk, PAAB Commissioner
Patrick Massad, Chief Review Officer (CRO), PAAB
Ann Sztuke-Fournier, Manager, Regulatory Advertising and Risk Communications/ Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate, Health Canada
Henry Anderson, Interactive Marketing – The Americas, Novartis Consumer Health, Inc.
Christian Roy (Montréal Session), Vice President, Marketing, Primary Care Business Unit, Pfizer Canada
Pat Forsythe (Toronto Session), Neuroscience Business Director, Allergan Canada
and me, Natalie Bourré, Medical Marketing and Social Media Consultant, Marketing 4 Health Inc.
Here is a summary of some of the key takeaways from the workshop. Keep in mind that my expertise is medical marketing and social media, and not regulations and guidelines. Therefore I must disclaim that what you will read in the following statements are my interpretations of how the Canadian regulatory guidelines impact the use of social media in the Canadian pharmaceutical marketing environment. Furthermore, guidelines may change over time. This post is considering regulatory guidelines as they exist as of November 2009.
If you would like to brainstorm and strategize ideas about the use of social media as part of your medical marketing, then please contact me at firstname.lastname@example.org . But if you already have an idea of what you want to do and just need to determine if your plans are within the Canadian pharmaceutical regulatory guidelines, then I would advise that you contact CRO Patrick Massad at the PAAB directly (http://www.paab.ca).
Before looking at some examples that were discussed during the workshop, the following statements need to be reviewed because these comments were mentioned over and over again during the workshops;
1. Every situation is evaluated on a case-by-case basis. As the PAAB looks at a promotional campaign in its entirety, it is difficult to give a clear-cut answer without knowing all the facts. For example, your social media program may be non-branded and acceptable as is because it is informational and not advertising. However, if it is somehow tied to an advertising piece, then it is considered advertising and must be reviewed by PAAB.
2. The intent of the campaign often determines if it is considered promotional or informational. To help you determine if your campaign is considered to be advertising (thus requiring PAAB review), take a look at the 7 questions provided by Health Canada’s policy on the “Distinction Between Advertising and Other Activities” (link to: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php) .
In fact, this point supports the 1st, as Health Canada states that “it is only after having determined that the primary purpose of a message is advertising that an assessment can be made regarding compliance with the regulations pertaining to drug advertising.” Get to know these questions because they apply to all promotional campaigns related to the pharmaceutical industry, not just social media.
3. Canadian guidelines are different than American guidelines. This post is not meant to go into details about these differences. However, it is important to note that direct-to-consumer (DTC) advertisement is highly restricted in Canada, where only the brand name, price and quantity can be mentioned while staying within our Canadian guidelines. So if the promotion’s intent is targeted to consumers in general and is considered to be promotional in intent (see point #2), it is not allowed in Canada. If the promotion is considered to be information only (no product focus), then it might be allowed in Canada. If you are unsure if your campaign is promotional or informational, contact The PAAB for guidance.
Keep in mind that DTC is not the same as direct-to-patient (DTP) information. DTP information distributed through health professionals is allowed in Canada as long as it is consistent with part 3 of the Product Monograph. It should be reviewed and approved by the PAAB with respect to section 6.4 of the PAAB Code of Advertising Acceptance. The difference between the two is that the target market for DTP are patients who have received a prescription for the drug in question and for DTC it is the general public.
Here are just a few samples of the discussions that took place during the workshops. Each discussion point mentioned below is meant as a stand-alone and does not necessarily have anything to do with the discussion point(s) mentioned prior to it;
Discussion 1: Assuming that a social network is developed for patients who have received a prescription for a drug (DTP), does the company have any responsibility with regards to any off-label comments made by a patient who is a member of the network?
Yes. As the owner of the network, the pharmaceutical company holds responsibility for ALL comments that are posted on the network, and these comments become part of the network, therefore they become part of the promotional campaign. As such, all comments made which are visible to other members must comply with the PAAB guidelines. Therefore, any off-label comments made by patients must be removed.
Discussion 2: The point of social media is to allow discussions to take place. What will patients think if pharmaceutical companies start removing or editing comments?
Regulators understand that comments enrich the discussions on social networks. However, as a highly regulated industry, we must abide by the guidelines. One remedy to the situation is to ensure that all members are made aware of certain requirements for posting comments right from the beginning. For example, let the network members know that any comments that mention prescription products will be removed or edited in order to comply with the industry’s guidelines.
How your company will decide to manage these situations will depend on your company’s level of risk aversion. To be entirely safe, your network may not allow any comments to be made at all. Perhaps your network will allow members to “like” certain information (ie. As in FaceBook), but will not allow written comments. Or perhaps your company will accept comments and will assign a person or preferably a team to monitor the comments and make changes as appropriate. Keep in mind that when you start a social network, it may evolve with time. You may wish to test the water at first by allowing members to “like” comments and then take the plunge to allow comments. Go at your company’s comfort pace. It is easier to add functionality than remove it later on.
If your company is comfortable with allowing comments, here are a couple of things to consider as part of your planning process;
i) Identify who in your company will be responsible for monitoring and making appropriate changes. If your network becomes very popular, this could become a very time-consuming task. Consider the personnel workload and costs that will be involved.
ii) Develop an SOP before initiating the process. In this SOP, consider as many scenarios as possible. In fact, you will probably have to demonstrate to the PAAB how you will deal with certain scenarios before they will approve your social network anyway (this is just my opinion – it is not something that PAAB stated).
Discussion 3: If a company has not set up a social media network themselves, but they are monitoring their product mentions throughout multiple social network sites, are they responsible for reporting adverse events?
Yes, but only if all 4 criteria that define an adverse event are met (drug, patient, reporter, event). Here is the link to the Health Canada guidance for ADR reporting: http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2009-guidance-directrice_reporting-notification/index-eng.php
Of course adverse events are a concern in our industry. It would be irresponsible for any one of us to dismiss the possibility of adverse events being reported online. Adverse events do get reported on social networks, but according to a recent study, this is a rare occurrence. In August 2008, Nielson Online published an article called “Listening to Consumer in a Highly Regulated Environment”. The article states that of 500 product reports that they looked at, and only 1 actually met all 4 adverse event criteria. Please remember that this study identified cases that included all four criteria and in real life you may have to follow up to get more information that would be available. At the moment, this is the only data that I am aware of that quantified adverse events reported online. If I find any others, I will be sure to blog about it. If you know of others, please let us know via the comments section.
Discussion 4: If a pharmaceutical company sponsors an online health professional journal, can that company include a reminder ad with a link to the full Product Monograph?
If the journal can be accessed by the general public, then linking to a product monograph for a prescription drug would not be acceptable. This would contravene the Canadian DTC restrictions which only allow drug name, price and quantity to be promoted to consumers.
If the journal is gated and is only accessible to healthcare professionals (HCP), then linking to a product monograph for a prescription drug would be acceptable.
This discussion generated comments that there is a discrepancy in how the regulators are viewing online journals versus printed journals. Printed journals for HCPs may contain approved drug ads, and the product label can be found at the end of the journal. Some HCPs leave their printed journals in their patient waiting rooms, thus giving access to patients to the ads within the journal. How is this different than a consumer having access to a link to a product monograph in an online journal? The answer is “intent”. With printed journals targeted to HCPs as seen by the name and address label, the intent is to advertise to the HCPs. HCPs leaving the journals in their waiting room is not under the pharmaceutical company’s control.
Discussion 5: Assume that a company sales rep posts comments on Twitter about a new study regarding a product that he or she promotes for your organization, and that the study is off-label. Should this be allowed since it was done during off-business hours?
No. This type of information should be removed and corporate policy should clearly dictate internal actions. An organization would not allow any of its employees to discuss upcoming strategies or prices with other individuals, whether it be during or outside of business hours. This should be considered as a breach of the company’s policies. Don’t have such a policy or SOP? It might be time to put together a team to start working on them. Looking for some social media policy guidelines from other companies? Take a look at Dave Fleet’s e-book on developing social media policies; http://davefleet.com/downloads/social-media-policies-ebook.pdf
I hope this helps clarify some questions, and I’m sure it has generated a whole bunch of new ones. Let’s keep the discussion alive. Send me your comments and feedback.
Stay in touch,
Marketing 4 Health Inc.