The Pharmaceutical Advertising Advisory Board (PAAB) is an independent and not-for-profit organization funded on a fee-for-service basis that preclears all advertising directed to healthcare professionals to ensure that it meets the regulatory, scientific, therapeutic, and ethical standards outlined in the Code of Advertising Acceptance. All PAAB approved advertising displays the PAAB logo. PAAB also provides a forum for competitors to complain that advertising is contrary to the Code.
Ray Chepesiuk has been at the helm of PAAB for the past 18 years as its Commissioner and CEO. Ray achieved a Pharmacy degree from the University of Toronto, a Master in International Business (Marketing) degree from the University of South Carolina and a Medical Marketing Certificate from UCLA. He is a Certified Association Executive (CAE). Prior to joining PAAB, he held management positions in community, hospital and government pharmacies and served on the Ontario College of Pharmacists Council. In 2009, he was inducted into the Canadian Healthcare Marketing Hall of Fame and in 1996, he received a U.N. medal for peacekeeping, which led to the Nobel Peace Prize for all previous U.N. peacekeepers.
We connected with Ray to ask about the year that has passed, trends in pharma advertising, and the year ahead.
In 2017, PAAB had the 3rd highest review volume ever. What are the common issues detected by your reviewers.
A. That has not changed much over the years. The most common things are inappropriate Fair Balance safety info, comparative claims, and inconsistency with Terms of Marketing Authorization. A newer increasing issue in the digital space are violations related to linkage of advertising to other information sources...
There were five complaints in 2017 that did not settle with intercompany dialogue and thus moved to Stage 2 for a reassessment by the Commissioner. All of the complaints were upheld, and concerned advertising that was not reviewed by PAAB. Was there any commonality in the nature of the five complaints?
A. Thanks for noting none of them had a PAAB logo on them. We still have some work to do to encourage compliance; however this is a low number. Two of them concerned biosimilars which is a new category, and we expect to see a lot of promotion into the future. Two of them were detail aids and we rely on industry to bring those to our attention. Three of them were from IMC member companies which is unusual regarding recent years.
In your “Note from the Commissioner” from January 2018, you mention that PAAB had its bilateral meeting with Health Canada on April 18, 2017 wherein you shared concerns. Can you tell us about some of the concerns that are on PAAB’s radar?
A. A recent activity that Health Canada has asked the PAAB to review is risk management materials which have been increasing in numbers. They are supposed to be informational in nature and Health Canada wants to ensure that through (PAAB) review. Of course, Medical Cannabis advertising would benefit from PAAB preclearance review if Health Canada reduces the current restrictions on advertising. A new development is that Health Canada will provide more resources to create an active monitoring program by Health Canada’s Marketed Health Products Directorate (MHPD). They have not been proactive in the past. An increase in biosimilar advertising and the competitive aspects associated with that is on the radar.
PAAB reviews around 7,500 distinct submitted advertisements per year. What mechanisms are in place to promote review consistency?
A. With 14 reviewers it is a challenge to provide consistent reviews. We have a robust training period that nurtures new reviewers early on with plenty of support from the Deputy Commissioner and experienced reviewer. They are, trained in regulatory, marketing and communications, and of course, in the application of the PAAB Code. We have extensive guidelines, electronic information repository systems, and communications apps that help the reviewers share information. To enhance knowledge retention and use, the reviewers are responsible for a few of the 26 therapeutic categories of healthcare products. While they work independently on files they do collaborate and consult other reviewers in their therapeutic category. We continually enhance the Efiles submission system to provide new tools to enhance productivity and consistency.
In January 2018, PAAB launched its Code of Advertising Acceptance in a new digital and interactive format at http://www.paabcode.innovasium.com. Although the content has not changed substantively, it has been organized in a more user friendly format with links between sections and to corresponding Health Canada documents. We are only a month in, but how has it been received by industry?
A. We have not had any negative input at this point and some positive comments. We will be conducting our annual client survey in February and we will obtain direct feedback from our clients about the Code App and other issues. We learn from this feedback and in the past this has led to improvements in our service offering to clients.
What is on the horizon for PAAB in 2018?
A. The board is focussing on the strategic plan that was developed in 2017 and my challenge is to find ways for PAAB to improve external communications and to find innovations to improve what we do. PAAB has been approached by the Canadian Animal Health (CAHI) to offer service for preclearance review and complaint resolution. The PAAB board will be considering this opportunity. Medical Cannabis advertising may present an opportunity for preclearance review if Health Canada allows advertising and the industry is willing to comply. Continuous system improvement is ongoing and a big part of 2018. We have seen a correlation between the number of new Notices of Compliance (NOCs) approved by Health Canada and the PAAB submission volume. A new confounder is whether or not the provinces and private insurers accept those new products for payment, and that affects the amount of promotion for those new products.
2017 was a busy year with many innovative projects to enhance our systems and bring transformational change. The staff is a little shell shocked from all the change we introduced, so we are looking at consolidating these new systems and tools to improve our service to PAAB clients. We hope that patients benefit from the service that PAAB provides to industry.