Pharmaceutical marketing compliance

Recently, a significant decision has provided guidance on the issue of the possibilities of going beyond the Summary of Product Characteristics (SmPC) in marketing of a medicinal product. The decision concerned Chapter 1, Section 1, Article 2 of the Ethical Rules for the Pharmaceutical Industry (LER). The article is important in the field of pharmaceutical information, encompassing the stipulation that a medicine’s SmPC constitutes the factual basis for information about the medicinal product.

The decision referred to GlaxoSmithKline’s (GSK) marketing of the drug Anoro Ellipta, used for the treatment of chronic obstructive pulmonary disease (COPD), and serves as an illustrative example of the complexities involved in promoting pharmaceutical products while adhering to regulatory standards and, in particular, Article 2 in LER.

Background

Anoro Ellipta, developed by GSK, contains two active substances, umeclidinium bromide and vilanterol. As a deposit copy, GSK provided the Information Examiner Committe (IGN) with promotional material regarding Anoro Ellipta. This material featured claims for the product, for example, ”ANORO ELLIPTA can significantly improve lung function compared to Spiolto Respimat” and ”Anoro Ellipta showed greater improvements in lung function and fewer symptoms compared to Spiolto Respimat, reducing the impact of COPD on the daily lives of patients”.

IGN initiated an investigation into GSK’s promotional material, focusing on the product claims mentioned above. IGN’s concerns revolved around whether these claims were substantiated by the SmPC. IGN argued that the claims in the deposit copy did not appear to be adequately grounded in the SmPC, potentially raising questions about compliance with Article 2 in LER. The SmPC constitutes the factual basis for information about the medicinal product. According to the wording of the provision that entered into force on 1 July, 2021, in addition to information directly taken from the SmPC or derived from it, other information may also be used in the information regarding the medicine. This presupposes that the information complements the SmPC by confirming or clarifying information contained therein, and that the information is consistent with the information contained in the SmPC.

Anoro Ellipta’s SmPC contained data from three clinical studies comparing the effects of treatment with Anoro Ellipta to Sprivia, a different medicine to the one mentioned in the promotional material. Given this comparison, IGN was uncertain whether it also encompassed the ability to compare with other medications, as GSK had done in the deposit copy.

GSK’s Defence

In response to IGN’s concerns, GSK argued that the product claims were, in fact, rooted in the SmPC, as they served to complement the information contained within it. GSK contended that the product claims validated and specified the details within the SmPC and were consistent with the information it provided. GSK’s interpretation of Article 2 of LER was that if the SmPC includes a comparison with a medicinal product, there should be support for comparisons with other medicinal products as well.

The Information Practice Committee

Following GSK’s submitted opinion, IGN referred the case to the Information Practice Committee (NBL) under the provisions of Section 23 of IGN and NBL’s procedural rules.

NBL’s assessment considered the changes in the interpretation of Article 2 in LER, which now permits the use of additional information in promotional materials, provided it complements the SmPC, confirms or specifies information in the SmPC and maintains consistency with it. NBL stated that when the SmPC includes a comparison with one medication, it should often imply support for comparisons with other medications as well. The SmPC for Anoro Ellipta presented the results of studies related to lung function and quality of life, in which Anoro Ellipta was compared to Spiriva. According to NBL, the disputed product claims pertain to similar comparisons between Anoro Ellipta and Spiolto Respimat. NBL concluded that the comparison of Anoro Ellipta with Spiolto Respimat was pertinent and that the claims supplemented the SmPC, aligning with the provisions of Article 2.

Conclusion

In conclusion, NBL cleared GSK of IGN’s concerns, stating that the promotional material adhered to Chapter 1, Section 1, Article 2 of LER. It is important to note that NBL’s decision solely pertained to Article 2, and other potential violations of LER or the scientific quality of the study from which the product claims were derived were not addressed in this specific case.

The case illustrates that information about a medicinal product does not necessarily have to be strictly tied to the SmPC; other information may also be used. If a comparison between two medicinal products is made in the SmPC, it may also provide the opportunity in marketing materials, to compare the medication to other medications, even if the comparison was not included in the SmPC.

Setterwalls looks forward to seeing what effect this decision will have in the field of pharmaceutical information, and is continuing to monitor the issue.