PAAB Code Revision Qualitative Research Report

1. PAAB Code Revision Qualitative Research Report CONFIDENTIAL Produced by:L. Meisner & Associates Inc. Produced for:Pharmaceutical Advertising Advisory Board Date: March, 2010 (490-01)

2. Overview Page • Introduction 3 • Findings 10 • 2007 Code Revisions 11 • Understanding the 2007 Code Revisions 12 • Overall Impressions of the 2007 Code Revisions 17 • Impact of the 2007 Code Revisions 24 • Potential New Code Revisions 31 • Winning Option 34 • Runner-up Option 39 • Least Interesting Option 47 • Thoughts Moving Forward 49

3. Introduction 3

4. Research Background • Prior to July 2007, the PAAB Code required Full Disclosure Prescribing Information (PI) • In 2006, a study was conducted with physicians on PI requirements • Ultimately industry requested that the PI be revised • On July 1, 2007, PAAB implemented revised requirements for PI, the purpose of which was to: • Make it easier for healthcare professionals (HCPs) to find, read and absorb the most important product information

5. Research Objectives • To determine the impact that PAAB code revisions have had on companies • To assess receptivity to possible new revisions to the PAAB Code regarding PI requirements

6. Method • 23 individual depth telephone interviews with senior regulatory and marketing staff members in Rx&D and selected PAAB clients in Toronto & Montreal • The target sample size was larger, however, some company contacts did not return calls, despite several attempts to reach them • Interviews conducted in February & March, 2010 • Interviews ranged from 10 – 30 minutes in duration • Of the 23 interviews: • 14 were with marketing staff members • 9 were with regulatory staff members

7. Recruiting Specifications • A list of key Rx&D and selected PAAB clients was provided, with one contact person per company • The contact person recommended, where possible, one marketing and one regulatory individual who: • would be sufficiently experienced and knowledgeable on the subject of PI • have enough history with the company to know the impact of the 2007 Code revisions • Unless otherwise specified, there are no significant differences based on market (Toronto vs. Montreal) • In some cases, where noted, there are some slight differences between the opinions of marketing vs. regulatory staff

8. The Sample • The sample consists of an excellent range of appropriate staff members • As expected some were more knowledgeable than others regarding the details of the 2007 Code Revisions, but all were sufficiently versed to offer valuable opinions • Within marketing, the positions represented include: • Promotions Coordinator, Commercial Development Supervisor, Product Manager, Senior Product Manager, Group Product Manager, Director of Business Operations & Effectiveness, Director of Market Access • Within regulatory, positions include: • Director of Regulatory Affairs, Assistant Director of Regulatory, Regulatory Affairs Manager, Manager of Regulatory Operations, Medical Manager, Associate of Regulatory Affairs

9. Nature of Findings • Please note that these findings are strictly qualitative • Caution – Small number of participants (i.e., not a large quantitative survey) • Participants were not drawn at random from population (as they would be in quantitative survey research) – we wanted to speak to specific qualified individuals • So this research does not measure, for example, awareness of the Code revisions in the general population • Rather, it provides insights on the range of opinions, and depth as to why these opinions are held

10. Findings

11. 2007 Code Revisions 11

12. Understanding of 2007 Code Revisions 12

13. All understand the intent behind the 07 revisions ... • Both the regulatory and the marketing respondents consider themselves reasonably familiar with the 2007 Code revisions • Rating their familiarity on a 10-point scale as: • 7 – on average for Marketing • 7.5 – on average for Regulatory Note: Familiarity was a requirement of participation. The contacts who were not sufficiently familiar, were not taken through the entire interview and an attempt was made to find a suitable replacement within the company.

14. Original intent is understood ... • When asked, “What is your understanding of the revisions that have been made to the PAAB Code as it relates to Prescribing Information requirements? ... • Most speak about the “intent”, and clearly suggest that they had positive expectations • The focus of their comments are on: • Quantity – they expected there would be an opportunity to reduce the overall quantity of the PI, by abbreviating certain sections • Font size changes – to make it easier to read • Re-formatting the layout – to make it easier to find the most important information

15. Issue – expectations did not match experience ... • In contrast to what was expected, typically the feedback suggests: • Disappointment, and • Expectations were not met • One contributing factor to the ultimate disappointment is that they feel they never got any feedback on the value of the revisions to the HCP customers • So, many were left questioning the value of their efforts (which were substantial) and the unexpected extra costs

16. The tone of the feedback evolved over the interview ... • Initially when speaking about their understanding of the 2007 Code revisions, typically the respondents’ tone is best described as: • Politely positive (i.e., focused on the positive motivation behind the changes, and not on the reality of their experiences) • Somewhat reserved • By the end of the interview, respondent were open about their experiences and often their disappointment with the 2007 Code Revisions was apparent

17. Overall Impressions of 2007 Code Revisions 17

18. Overall impressions = slightly negative impact ... • When asked, “How would you rate the impact that the PAAB Code revision has had on your company’s overall journal advertising for promoted prescriptions products since July 2007? ... • The majority indicate a negative impact: Very Negative No Very Positive Impact ImpactImpact • On average, regulatory have the impression of a slightly more negative impact, compared to marketing • At least in part because they had to work through the details of the content revisions and felt responsible for any potential legal liability Most responses fall in this range A small minority fall in this range

19. Value of the revisions is questioned ... • When asked why they felt the overall impact was negative, the focus of the justifications differ subtly between regulatory and marketing respondents ... • Regulatory are focused on the extent of extra work that was involved – some really seemed to struggle to abbreviate, but ultimately felt they could not do so “We explored ways to work with the requirement and get it shorter but we couldn’t! It was 4 times longer than what was budgeted, so we walked away from journal ads ... We negotiate every word in our product monograph and it’s not appropriate to change things. Our medical department had significant concerns about editing it.” Regulatory

20. Value of the revisions is questioned ... “Overall it takes more time. It adds to the burden, and makes it more difficult to say anything.” Regulatory “We had to re-visit every product monograph ... Just juggling things around ... all the same information ... and then to the agency and they had to reformat it. It added a lot of work that was of no value.” Regulatory

21. Value of the revisions is questioned ... • Marketing respondents had more diverse justifications for the negative impact they felt – they talked about extra work plus other consequences such as cost ... “The cost of the PI went up.” Marketing “Cost – after the revision, 52% of our spending was on PI [vs. colour part of ad].” Marketing “The PI takes a lot of space and we ended up spending too much on PI and not enough on the colour ad.” Marketing

22. Value of the revisions is questioned ... • Some marketing (and regulatory) respondents also feel there was lack of clarity on how to abbreviate “There were no standard guidelines on how to reduce content so we prefer to comply with Health Canada.” Marketing “There was some confusion as to how to abbreviate, and some actually grew in length.” Marketing

23. Value of the revisions is questioned ... • Importantly, they are not at all clear that the HCPs even look at the PI, so there is a sense of futility due to lack of feedback from physicians “The value of it is so unqualified and the impact is indirect.” Marketing “At the end of the day, we are not sure that anyone even reads the stuff.” Marketing “I haven’t heard that doctors look at the PI. There is nothing to say the change helped doctors or that it was read more – and it cost more!” Marketing

24. Impact of 2007 Code Revisions 24

25. Amount of PI, post 2007 revision ... • When asked more specifically about the extent of impact of the 2007 Code Revision (vs. Full Disclosure PI) on: • The Amount of Prescribing Information ... Significantly No Significantly Less Change More • Regulatory respondents, on average, rate the impact slightly higher (i.e., more prescribing information post revision), than do marketing respondents Most responses fall in this range A small minority fall in this range

26. # of PI pages, post 2007 revision ... • When asked about the extent of impact of the 2007 Code Revision on: • The # of Prescribing Information pages ... • Results are very similar: Significantly No Significantly Less Change More • Here again, regulatory respondents, on average, rate the impact slightly higher (i.e., more increase in the # of PI pages), than do marketing respondents Most responses fall in this range A small minority fall in this range

27. Total # of Journal Ad Insertions, post 2007 revision ... • Lastly respondents were asked about the extent of impact of the 2007 Code Revision on: • The Total # of Journal Ad Insertions ... • Results show neutral to slight decrease in # insertions: Significantly No Significantly Less Change More • Once again, regulatory respondents, on average, rate the impact as slightly stronger (i.e., decrease in the # of ad insertions), than do marketing respondents • A few regulatory (and 1 marketing) respondents did not know the impact on total # of insertions • Some also say it’s difficult to isolate the impact of Code Revisions (vs. other corporate “belt-tightening” factors) on the total # of ad insertions All responses fall in this range

28. Summary Comments on 2007 Code Revision ... • After thinking specifically about amount of PI content, # of pages and insertions, some respondents had a few final comments on the Code Revisions • Overall the comments are more negative than positive, with key issues including: • Longer PI • Increased cost – time (internal & agency), and cost for # pages • Increased work • Delays in processing approvals • Legal liability concerns

29. Summary Comments on 2007 Code Revision ... “It would be nice to know if they accomplished what they wanted with the 07 code revisions.” Marketing “Someone should do a survey to see if doctors really read the PI. Our challenge is to get physicians to even stop and read the colour ad, nevermind the PI!” Marketing “I don’t know if it’s easier for doctors. I don’t know if physicians even read the PI. They should do a survey to see if it’s worth the time and hassle.” Marketing

30. Potential New Code Revisions 30

31. 3 Potential Options … The following 3 potential options were assessed: • No change from current requirements/format • In Canadian Medical Publications, remove the PI and replace it with copy in a prominent location within the ad that directs the reader to the Health Canada Drug Product database (DPD) • At least 1-2 years from the time the product is introduced in Canada, provided there are no reports of unsuspected adverse effects of significance to warrant a warning letter from Health Canada or the manufacturer, remove the PI and replace it with copy in a prominent location within the ad that directs the reader to the Health Canada Drug Product database

32. 3 Potential Options … • After hearing all 3 potential options, respondents rated their interest in each one on a 1-10 scale (1= Not at all interested ... 10 = Very Interested) • The order of ranked interest is similar for both marketing and regulatory respondents • Overall, on average: • The Winner = Option #2 (remove PI effective immediately) • The Close Runner-up = Option #3 (remove PI 1-2 years post launch) • The Least Interesting = Option #1 (status quo) • Both Options #2 & 3 were far preferred to staying with the status quo (Option #1)

33. Winning Option 33

34. The Winner – Remove PI Immediately ... • The most frequently mentioned reason for preferring this option is “cost savings” • A few also mention that if they could save costs on PI they would run more journal ads • Another very commonly mentioned justification for this selection is “less work” • They say this option would mean there is no additional work beyond updating the product monograph – which would save considerable time for marketing, regulatory, medical and advertising agencies • A third and interesting reason given is that some believe online access is ultimately better than paper – provided that the link is simple and fast • It is readily accessible (just bookmark the link) • It will ensure that physicians get the most current PI possible (assuming that the Health Canada database is up to date) • It is a natural evolution in the electronic age

35. The Winner – Remove PI Immediately ... • Online access is ultimately better than paper (cont.) ... • It is consistent – physicians go to the same place all the time – they are less likely to miss updates • It is a comprehensive resource • Anotherreason for liking this option is many believe physicians do not look at PI in journals (or strongly suspect so) “Journal ads just keep products top of mind.” Marketing

36. The Winner – Some Concerns Exist ... • Despite the overall preference for removing PI immediately, there are some slight concerns or worries, including: • Lack of clarity on exactly how up to date the Health Canada DPD is kept – for instance, one queried whether the monographs for older products are posted on the site • There is also the concern that the “copy in a prominent location directing the reader to the Health Canada DPD” ultimately might be too much extra copy to insert in the ad • It might clutter up the look of the ad if it is too verbose • If it simply says something like “For PI go to www....” – that would be acceptable • Because there is lack of certainty about how much, if at all, physicians look at the PI in journals, some have a lingering thought that maybe for new products physicians may want access to the PI in journals “just in case they are not online”

37. The Winner – Some Concerns Exist ... • One other worry that was mentioned is ... “What if PAAB gets even more restrictive if the PI is removed?” Some reassurance on this issue would be appreciated, if possible.

38. Runner-Up Option 38

39. The Runner-Up – Remove PI in 1-2 Years ... • There is an interesting contradiction in what respondents say about this option – one could argue that they speak out of both sides of their mouths: • On the one hand there is some comfort in the way things have “always” been done (even though they voice significant complaints about the status quo) – change can be a bit scary • At the same time there is a strong belief among many, that physicians do not read the PI in journals – this is not their 1st, or even their 2nd most used source • But then they go on to justify this “Runner-Up Option” saying, “ Well for the first 1-2 years it might be good to keep it in the journal, just in case” – to avoid any risk (yet they are hard-pressed to clearly articulate the exact nature of what is at risk)

40. The Runner-Up – Remove PI in 1-2 Years ... • The justifications for considering this option suggests that there is a delicate balance between: Wanting to save money and spend less on PI Wanting to do duediligence and allow physicians immediate access to PI if they need & want it

41. The Runner-Up – Remove PI in 1-2 Years ... • The most frequently mentioned reason for preferring this option is “maybe doctors will want to go there for new products” • Another reason given for this option is that paper may be the only source for some doctors (i.e., not all doctors are online) • They say this without any certainty or true conviction ... again it’s a “just in case” justification • A few respondents also say that this option allows them to feel they are being prudent – providing necessary information to customers

42. The Runner-Up – Remove PI in 1-2 Years ... • One unique perspective from a regulatory respondent was that there is more comfort in having the PI in the journal just while the product is new, but for older more established products the website is fine ... “Not because doctors necessarily read the PI in journals, more from a legal regulatory standpoint – it’s how it has always been and we are risk averse.” Regulatory

43. The Runner-Up – Some Reservations Exist ... • The downside of this option (relative to the winning option) is that cost savings would not be as great • Another interesting reservation that was mentioned by several respondents relates to consistency: “This is less desirable because it is less consistent – do it one way or the other!” Marketing “The other option is better because you need to be consistent – train people to always go to the same place.” Regulatory

44. The Runner-Up – Some Reservations Exist ... • Concern about interpretation issues was also raised by several – this option opens up the potential for misinterpretation which is undesirable: “They would need to be very clear on all time frames. I worry about interpretation. For instance do they mean 1-2 years from the date of DIN notification or from NOC?” Regulatory “I worry about interpretation around the AE clause – what’s unexpected vs. expected? ... in the product monograph or not?” Marketing

45. The Runner-Up – Some Reservations Exist ... • Insight • Regardless of how valid or not these concerns seem, it is important to recognize that they seem to be symptomatic of an underlying concern about interpretation of the Code in general. • These people do not want to have to deal with the inconveniences (time and effort) that all parties experience when approvals are delayed due to inadvertent misinterpretations and misunderstandings.

46. Least Interesting Option 46

47. Least Interesting Option – Status Quo ... • It is interesting to see that the status quo pales in comparison to the other 2 options that were assessed, particularly given that initially respondents were not overly negative about the current Code – they were just slightly negative • As soon as other interesting options were tabled the Current Code quickly sank to the bottom rank ... Why? • They simply prefer the other options • The other options are interpreted to potentially result in significant cost savings • They are not certain that physicians read the PI in journals • Consistently, they do not feel that the benefits they expected from the 2007 Code Revisions, were actually realized • Not shorter, not cheaper, and certainly not less work

48. Thoughts Moving Forward

49. Thoughts Moving Forward ... • The following thoughts are offered for your consideration, based on the findings of this exploratory research • Although there is not a high degree of abject dissatisfaction with the current Code, the opportunity to improve upon it seems clear • The two new options that were assessed both have merit, and pros and cons, with one (remove PI immediately) having a slight edge over the other • Either one would likely be a great improvement over the current Code

50. Thoughts Moving Forward ... • One theme that permeates many of the comments is that all communication related to this potential change needs to be abundantly clear: • Why the change is being made • Reassurance about ease of use for physicians • Accurate information regarding the status of Health Canada’s DPD update status – for example: • How frequently are updates made? • Are there backlogs? • Are monographs for both new and old products posted? Any exclusions?