AstraZeneca: Symbicort Turbohaler promo email subject line missing generic name (AUTH/3664/6/22)

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Key facts

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Case	AUTH/3664/6/22
Company	AstraZeneca
Product	Symbicort Turbohaler (budesonide, formoterol fumarate)
Material type	Promotional email
Main issue	Subject line used brand name without non-proprietary name immediately adjacent at first appearance; concerns about certification arrangements
Complainant	Anonymous, contactable complainant (described themselves as a health professional); also taken up by the Director
Applicable Code	2021
Breach clauses	Clause 5.1; Clause 12.3
No breach clauses	Clause 2; Clause 3.3; Clause 5.1 (in relation to alleged breach of undertaking)
Undertaking allegation	Alleged breach of undertaking from Case AUTH/1800/2/06; Panel found cases sufficiently different and ruled no breach of Clause 3.3
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	21 June 2022
Case completed	8 June 2023
Appeal	No appeal

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, contactable health professional complained about a promotional email for Symbicort Turbohaler (budesonide, formoterol fumarate).
The email subject line was: ‘AstraZeneca promotional email: Symbicort Turbohaler – Device matters when prescribing MART’.
The complainant alleged the brand name appeared in the subject line without the generic name, raising Clause 12.3.
The complainant also alleged this repeated an earlier issue (Case AUTH/1800/2/06) and therefore breached an undertaking (Clause 3.3), and asked the Authority to consider Clause 5.1.
AstraZeneca accepted the non-proprietary name was not included adjacent to the brand name in the subject line at first mention and accepted a breach of Clause 12.3.
AstraZeneca said the subject line was changed after the review round and the change was not flagged to reviewers/signatories; the signatory did not realise the final email form/attachments included an amended subject line.
The Panel noted the non-proprietary name (budesonide/formoterol) appeared near the top of the email body, but the subject line was the first appearance and might be the only part read.
The Panel was concerned the certified document did not include the subject line as part of the final form uploaded for certification; it was effectively in meta-data/attachments rather than integral to the certified item.

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Breach of Clause 12.3 (non-proprietary name not immediately adjacent to brand name at first appearance in an electronic advertisement).
Breach of Clause 5.1 (failing to maintain high standards) due to concerns about certification arrangements (subject line not integral to the certified final form).
No breach of Clause 3.3 (requirement to comply with an undertaking) in relation to the alleged breach of undertaking from Case AUTH/1800/2/06.
No breach of Clause 2 (discredit to the industry) in relation to the alleged breach of undertaking.
No breach of Clause 5.1 in relation to the alleged breach of undertaking (the Panel treated this separately from the certification-arrangements breach).
No appeal.

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Breach of Clause 5.1 Failing to maintain high standards
Breach of Clause 12.3 For electronic advertisements, the non-proprietary name of the medicine must appear immediately adjacent to the brand name at its first appearance
No Breach of Clause 2 Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry
No Breach of Clause 3.3 Requirement to comply with an undertaking
No Breach of Clause 5.1 Requirement to maintain high standards

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