Key Topic 1: Market Research - Subtopic 2: Non promotional
It is extremely important that market research cannot be deemed as a promotional activity or as having a promotional intent. This applies whether a product has a marketing authorization or not at the time of the research. Research materials must appear non promotional. Branding and excessive use of brand names should be avoided (except for the purposes of specifically testing branding concepts which is allowable).
The non promotional nature of the activity should be clear to those taking part.
Here is an example of a disclaimer that AstraZeneca uses in some market research involving sharing of speculative clinical trial data:
This interview will involve discussion of speculative data and projections not based upon the actual results of the [NAME] clinical trial and is for market research purposes only. THIS INTERVIEW WILL INCLUDE INFORMATION RELATING TO STRATEGIC DECISIONS REGARDING THE FUTURE OF THE BRAND AND IS NECESSARILY FORWARD-LOOKING. [Brand x] is not approved by the US FDA/cFDA/MHLW/EMEA for the treatment of [insert indication under study]. AstraZeneca does not, under any circumstances, promote its products for off-label or unapproved uses.
The results of a piece of market research can be used in promotion. However it is important that both phases are kept entirely separate.
Consider these examples
Promotion presented as research
In the US the FDA issued a warning letter regarding some activities undertaken by Schering with respect to their product Vancenase nasal spray.
The FDA said that Schering had disseminated misleading promotional messages during promotional presentations that Schering had called ‘research’. Schering had misrepresented the nature of the activities. The FDA had videos that showed company representatives making numerous statements that ‘promoted Schering’s drug products as being superior to its competitor products’. They also stated that the presentations made were more like ‘detailing a group of health care providers’ than market research. For example 37 slides with introductory or technical information were presented in a one- hour session.
Schering were ordered to deliver a ‘corrective campaign’ in ‘communication formats with similar impact’.
In the letter the FDA made some interesting statements about market research versus promotion as follows:
- The natural defensiveness by which people process promotional messages was circumvented by the presentation of the messages as ‘research’.
- It is well established that participants in research studies are likely to be highly sensitive to, and compliant with, information presented in a research environment.
- Materials presented as educational in nature are more fully accepted and integrated into the research participants personal belief systems than material clearly identified as promotional.
Disguised promotion?
In the UK a consultant neurologist complained about a survey headed ‘Neurology Pharmaceutical Survey’ sent by a market research agency which consisted of two pages of 22 questions and sub-questions. Most of the questions related to the use of botulinum toxin injections. Six of the questions specifically referred to the use of botulinum toxin injections for the treatment of primary headache or migraine.
The identity of the commissioning pharmaceutical company was not clear from the documentation. The agency confirmed that it was Allergan. Allergan marketed Botox (botulinum toxin). Botox was not licensed for the treatment of primary headache or migraine.
Allergan said that the purpose of the survey was to seek information and opinion from senior health professionals actively involved in the management of primary headache and migraine. The information gained would ensure that Allergan’s communications were effectively targeted. The survey had been sent to over 800 clinicians.
One question asked which was the respondent’s preferred brand and named each botulinum toxin injection brand available in the UK. Another question similarly named all the brands. None of the botulinum toxin injections currently marketed were licensed for the treatment of primary headache or migraine.
Another question asked ‘Are you currently aware of the use of botulinum toxins for any type of primary headache or migraine?’
The next question asked clinicians to choose which one of four statements best described their usage intentions of botulinum toxins for headaches/migraine assuming that such a use was officially approved. The third statement read ‘I am not interested in trying botulinum toxins for headache/migraine patients, neither injecting them or referring them, unless they become a very common and successful treatment for headache/migraine’
Which of the following do you agree with:
- This is unacceptable as the questions are about an unlicensed indication
- Sending a market research survey to 800 clinicians is unlikely to be considered acceptable
- The nature of the questions may stimulate interest in an unlicensed indication
- This is disguised promotion
- This is likely to be viewed as off-label promotion
Ruling
The UK Authority considered that the nature of the questions and the survey’s broad distribution to over 800 clinicians was such that it went beyond merely seeking information and opinion from senior clinicians actively involved in the management of primary headache and migraine conditions as submitted by Allergan. The questions would stimulate interest in the use of botulinum injections for an unlicensed indication. In the Panel’s view the survey was a marketing tool and not genuine market research. The Panel ruled that the material at issue promoted botulinum toxins in the guise of a survey. In that regard the promotional activity was disguised.
