In the highly competitive pharmaceutical industry, companies must carefully navigate the complex regulatory landscape when promoting their products. A recent case ruling by the Prescription Medicines Code of Practice Authority (PMCPA) highlights the importance of ensuring promotional claims are accurate, balanced and supported by robust evidence.

The case in question involved a complaint filed by Chiesi Limited against GSK UK Limited regarding the promotion of Trelegy Ellipta, GSK’s single-inhaler triple therapy for the treatment of chronic obstructive pulmonary disease (COPD). The PMCPA panel’s rulings provide valuable insights for pharmaceutical companies on complying with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice.

Trelegy Ellipta is indicated as a maintenance treatment for adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta agonist plus a long-acting muscarinic antagonist. The case concerned various promotional claims made by GSK about Trelegy, including a banner advertisement, superiority claims, the use of data from a network meta-analysis, and a claim about the Ellipta device.

Overarching Principles of the ABPI Code
The ABPI Code of Practice sets out the ethical standards that pharmaceutical companies must adhere to when promoting their medicines in the UK. Key overarching principles include:

• Information, claims and comparisons must be accurate, balanced, fair, objective and unambiguous, and must be based on an up-to-date evaluation of all the evidence (Clause 6.1)
• Any information, claim or comparison must be capable of substantiation (Clause 6.2)
• Artwork must conform to the letter and spirit of the Code (Clause 14.4)
• Activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry (Clause 2)

The PMCPA panel’s rulings in the Trelegy case provide important lessons for how these principles should be applied in practice.

Banner Advertisement: Depicting the “Climate Emergency”

One of the key issues in the case was a banner advertisement that appeared on the Trelegy website, which featured three inhalers (including Chiesi’s Fostair inhaler) alongside a prominent “Climate Emergency” headline.

Chiesi alleged that the use of the inhalers alongside the “Climate Emergency” headline was misleading and disparaging towards their product and others. GSK argued that the advertisement was intended to illustrate the need to reduce the environmental impact of inhalers, in line with NHS guidance.

The PMCPA panel ruled that, within the context of the Trelegy website, the advertisement was not misleading or disparaging. The panel acknowledged the well-established link between inhaler use and environmental impact, and considered that the advertisement was referring to this in a general sense, rather than implying any specific product was particularly associated with the “climate emergency”.

This ruling highlights the importance of considering promotional materials within their full context. While individual elements may raise concerns, the overall message and intent of the material must be assessed. Pharmaceutical companies should ensure that any environmental claims are presented accurately and objectively, without unfairly disparaging competitor products.

Superiority Claims: Substantiating Comparisons

Another key issue in the case was GSK’s claim that Trelegy was “The only choice with 21st century molecules and evidence of in-class superior components.” Chiesi alleged that this claim was misleading and could not be substantiated.

The PMCPA panel found that on Trelegy’s homepage, where the claim appeared alongside qualifying information about the comparisons, it was not misleading or unsubstantiated. However, on the Trelegy “Molecules” webpage, the panel ruled that the claim was ambiguous, as the comparator was not sufficiently clear.

The panel’s rulings highlight the importance of ensuring comparative claims are presented in a clear and unambiguous manner, with appropriate contextual information. While the homepage provided sufficient detail to understand the nature of the comparisons, the molecules page did not, leading to a finding of a breach.

Pharmaceutical companies must be cautious when making superiority claims, ensuring that any comparisons are accurately reflected and fully substantiated by the available evidence. This is particularly important when dealing with complex topics like network meta-analyses, where appropriate caveats and limitations must be clearly communicated.

Network Meta-Analysis: Balancing Transparency and Interpretation
The case also examined GSK’s use of data from a network meta-analysis (NMA) to support claims about Trelegy’s efficacy compared to other single-inhaler triple therapies. Chiesi alleged that GSK’s claims were misleading and exaggerated the evidence.

The PMCPA panel acknowledged that NMAs are a useful tool for comparing interventions in the absence of head-to-head trials, but noted that their validity relies on several assumptions being met. The panel found that while GSK’s NMA was the largest and most robust available, the presentation of the results in promotional materials was not sufficiently balanced or transparent.

Specifically, the panel ruled that GSK’s claim of “Greater annualised moderate/severe exacerbation reduction vs. other COPD single-inhaler triple therapies” was misleading, as it did not clearly distinguish between the statistically significant reduction versus Trixeo and the non-significant reduction versus Trimbow. The panel also found that a combined claim about lung function improvements and exacerbation reductions was misleading, as it implied statistically significant benefits in both areas that were not borne out by the data.

The panel’s rulings underscore the importance of ensuring that comparative claims based on NMA data are presented in a clear, balanced and transparent manner. Pharmaceutical companies must take care to distinguish between statistically significant and non-significant results, and provide appropriate context and caveats to avoid misleading healthcare professionals.

Ellipta Device Claims: Substantiating Preference and Performance

The final issue in the case concerned GSK’s claim that healthcare professionals should “Don’t settle for an MDI, when you can give the preferred, easy-to-use Ellipta device.” Chiesi alleged that this claim was misleading and disparaging towards metered-dose inhalers (MDIs).

The PMCPA panel found that the claim was ambiguous and misleading, as it was not clear whether the “preferred” designation referred to prescription volumes, patient preference, or some other metric. The panel also considered that the phrase “Don’t settle for an MDI” created an unfair impression about competitor products, going beyond simply advocating a shift to lower-carbon inhalers where clinically appropriate.

This ruling highlights the need for pharmaceutical companies to ensure that any claims about the performance or preference of their devices are unambiguous and fully substantiated. Superlative claims should only be used where they relate to a clear, substantiated fact about the product.

Additionally, the panel’s concerns about the “Don’t settle for an MDI” phrase underscore the importance of avoiding disparaging language about competitor products, even when promoting environmental benefits. Companies must strike a balance between advocating for more sustainable options and respecting the role of different inhaler types in meeting individual patient needs.

Implications for the Pharmaceutical Industry
The PMCPA’s rulings in the Trelegy case have several important implications for the pharmaceutical industry:

1. Contextual Awareness: Promotional materials must be considered in their full context, not just individual claims or elements. Companies should ensure the overall message and intent is accurate, balanced and objective.

2. Substantiation of Comparisons: Comparative claims, including those based on complex analyses like NMAs, must be clearly substantiated and presented in a transparent manner. Ambiguity or selective reporting of results can lead to misleading impressions.

3. Balanced Promotion of Benefits: When promoting the benefits of a product, companies must take care to accurately reflect the evidence, distinguishing between statistically significant and non-significant outcomes. Exaggerated or all-embracing claims should be avoided.

4. Respectful Competition: While companies can advocate for more environmentally sustainable options, they must do so in a way that does not unfairly disparage competitor products. Promotional materials should avoid language that creates an unfair impression about alternative treatments.

5. Compliance with Undertakings: When a company has provided an undertaking to the PMCPA following a previous breach, it must take all possible steps to avoid similar breaches in the future. This includes ensuring learnings are effectively implemented and communicated across the organization.

The PMCPA case highlights the importance of a robust compliance framework within pharmaceutical companies. Strict review processes, comprehensive training, and a culture of ethical decision-making are essential to ensure promotional activities adhere to the ABPI Code and maintain public trust in the industry.

Conclusion

The PMCPA’s ruling in the Trelegy case provides valuable lessons for the pharmaceutical industry on the importance of accuracy, balance and transparency in promotional activities. By carefully applying the principles of the ABPI Code, companies can navigate the complex regulatory landscape and continue to responsibly inform healthcare professionals about the benefits of their products.

Upholding the highest ethical standards is not just a regulatory requirement – it is fundamental to maintaining the industry’s social license to operate and delivering the best possible outcomes for patients. The Trelegy case demonstrates that even minor missteps can have significant consequences. Vigilance and a commitment to self-regulation are essential to protect the industry’s integrity and ensure it continues to fulfill its vital role in improving healthcare worldwide.

Reference(s)

1. CASE AUTH/3719/12/22

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ABPI | PHARMACEUTICAL MEDICINE | PMCPA | PROMOTION