Top 10 code mistakes and omissions with promotional material
By Celia In Medical Communications On November 17, 2014
Recently I was asked about key elements to look for when reviewing promotional materials for compliance with Medicines Australia Code of Conduct. I’ve summarised some common errors and omissions below:
- Hanging comparators: One of the most common omissions I see is the lack of a comparator. It is insufficient to make a claim about a product, for example “Product X improves symptom severity“ without stating the comparator. Is symptom severity, in this case, better than placebo or another product? Or was symptom severity with Product X improved at a particular time point compared from baseline?
- Insufficient qualification: All claims must be sufficiently qualified to ensure they are accurate and balanced. For example with the claim, “Product X improves symptom severity”, further information is necessary to support the claim, such as what specific symptom(s) were measured, what dose and duration of treatment were used? How was symptom severity measured? Qualifying statements must be linked to the claim, using a readily identified symbol such as an asterisk, in 3 mm print size (as measured from lower case letter ‘e’ for printed materials) and positioned immediately below or adjacent to the claim.
- Unqualified animal or in vitro data: This data should not be used as the sole evidence to support a promotional claim. A qualifying statement that animal or in vitro data may not necessarily predict clinical effects must be stated.
- Graphical omissions: Graphics need to be checked carefully, often several times over, to ensure they are accurate, current and balanced, and not mislead either directly, by implication, or by omission. Sometimes patient numbers, treatment strength, treatment duration, time period over which the endpoint was measured, and statistics (such as p value) are omitted. Ensure x and y axes are adequately labelled, data is accurate and units of measurement are provided. The study design details must be included and there should be sufficient information about the measured endpoint. If the graph is based on another source, it should state “Adapted from…….” with the appropriate reference citation included.
- Taglines with unqualified superlatives: Taglines must be adequately referenced and qualified. You must not imply a product is unique or has some special merit unless it can be adequately substantiated with evidence of sufficient quality to support the claim.
- Insufficient detail to stand on its own: Each page must be adequately substantiated, referenced with all the necessary qualifiers. In particular, ensure “Summary” pages pass the “stand alone” test.
- Unreferenced material: All claims and data must be adequately substantiated and referenced. In particular, check headings carefully, as titles may be phrased as a promotional claim and, therefore, must be adequately referenced.
- Insufficient evidence to support a claim: Any information used to support a claim must include sufficient detail and be of adequate quality to validate the claim. In particular, comparator claims must be based on unequivocal data. Just because one study reported improved quality of life with Product X compared to a competitor, does not necessarily mean the body of evidence supports superior quality of life. What is the quality of the study? For example, a systematic review of randomised controlled clinical trials is stronger evidence than a retrospective, post-hoc marketing-driven analysis of prescription data. The substantiation of a claim must not rely solely on “data on file”, abstracts or posters.
- Unregistered products and indications: Caution when reviewing materials sourced from an international affiliate. Particular care must be taken as products and indications approved by the Therapeutic Goods Administration in Australia may vary from overseas regulatory bodies.
- Inappropriate use of post-hoc analyses and secondary endpoints: The use of post-hoc analyses may be acceptable, according to Section 1.2 of the Code of Conduct, but they must be clearly identified, used in context of the primary end point(s) and appropriately qualified. Carefully examine claims based on secondary endpoints, particularly if the primary endpoints are not met, as they must be consistent with the body of evidence, accurately reflect the conclusion of the study and include a qualifier if the primary endpoint was not met.
Please note this blog is intended only as a brief vignette and is not in any way a comprehensive report of all compliance issues. For further information, please refer to Medicines Australia Code of Conduct and supporting guidelines (see: http://medicinesaustralia.com.au/code-of-conduct/code-of-conduct-current-edition/) together with any other relevant regulations and legislation and internal company guidelines.