AUTH/3587/12/21 - Anonymous health professional v AstraZeneca

Promotion of Symbicort and alleged breach of undertaking

  • Received
    02 December 2021
  • Case number
    AUTH/3587/12/21
  • Applicable Code year
    2021
  • Completed
    16 June 2022
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    Appeal by the complainant

Case Summary

An anonymous complainant who described him/herself as a health professional complained about the promotion of Symbicort (budesonide formoterol fumarate dihydrate) by AstraZeneca. The material at issue was a webpage.

The complainant was concerned that AstraZeneca had not provided prescribing information or the generic name adjacent to brand mention for Symbicort. The complainant also alleged that the spirit of the Code was also not met by a breach of undertaking.

The complainant provided a link to a promotional page with cost claims about Symbicort Turbohaler and although price and brand name were mentioned with great frequency, no generic name was provided next to any of the 3 mentions of Symbicort and no prescribing information was available. The complainant alleged breaches of the Code including Clause 2. If a disclaimer was clicked on to say read and accepted, this then moved onto showing a graph with Symbicort prices (GB-25816: February 2021) with % discount quarter.

The complainant stated however, no generic name or prescribing information was available for this promotional graph. This was also alleged to be in breach of the Code including Clause 2. The Panel had already found AstraZeneca in breach for not providing prescribing information for Symbicort in a different case (Case AUTH/3488/3/21). The complainant alleged a breach of the undertaking provided from the previous case as the prescribing information for Symbicort was again not provided, alongside an alleged breach of Clause 2 for not obeying the undertaking.

The detailed response from AstraZeneca is given below.

The Panel noted that the complainant had provided a link to the material at issue but provided no information as to how he/she had accessed the material. The case preparation manager downloaded the material from the link and provided it to AstraZeneca when notifying the company of the complaint.

The Panel noted the complainant’s allegation that the webpage at issue, a Symbicort cost calculator on the medicines.astrazenca.co.uk website, omitted the non-proprietary name for Symbicort and lacked prescribing information in breach of the undertaking given in Case AUTH/3488/3/21.

The Panel noted AstraZeneca’s submission that the webpage at issue was still undergoing approval and had not yet been certified or issued. According to AstraZeneca, the webpage could only be accessed using a specific URL link, it could not be navigated to via the AZ Medicines website and was not indexed or optimised for search engines.

The Panel noted that the webpage was not restricted in any way and that it could access it without any indication that the webpage was in draft form or was undergoing approval. The Panel noted AstraZeneca’s submission that the specific test link was used only by the approval team, was not shared outside the approval system and the webpage could not be accessed by a visitor using search engine terms or through browsing the AstraZeneca website. The Panel further noted AstraZeneca’s submission that the link sent to the PMCPA had only ever been accessed by internal AstraZeneca staff members prior to the date of the complaint.

Taking all the factors into account, and on the evidence available before it, the Panel did not consider that the lack of obligatory information on what appeared to be internal material on a staging/test link for draft content amounted to breaches of the Code as alleged. It therefore ruled no breaches of the 2021 Code. The undertaking signed in Case AUTH/3488/3/21 had therefore not been breached, and the Panel ruled no breach of the 2021 Code.

In the Panel’s view, companies should ensure that draft promotional material which was only meant for internal use was inaccessible by people outside of the company. Given its rulings and the specific circumstances of this case, the Panel did not consider that there was evidence to show that the company had failed to maintain high standards and no breach of the 2021 Code was ruled. The Panel did not consider the circumstances warranted a ruling of a breach of Clause 2 which was reserved as a sign of particular censure. No breach of the Code was ruled.

Upon appeal by the complainant, the Appeal Board noted that the complainant had the burden of proving his/her complaint on the balance of probabilities. AstraZeneca stated that there had been no evidence of a technical failure and it had checked that the cost calculator could not be accessed directly from its medicine’s website nor was it discoverable by searching on Google. The cost calculator was only accessible via a complex link. The Appeal Board noted AstraZeneca’s submission that only its review team had access to the cost calculator via the item’s job bag; investigations by the company’s digital team found that the only recorded external single access to the webpage in question appeared to be consistent with the PMCPA case preparation manager accessing the page via the link in the complaint.

The Appeal Board considered that the complainant had not provided any evidence to show that the cost calculator, that was still undergoing the internal approval process, could be accessed from the AstraZeneca medicines website as alleged. The Appeal Board agreed with the Panel’s comments above and upheld its rulings of no breaches of the 2021 Code including Clause 2. The appeal was unsuccessful.