AUTH/3683/8/22: Complainant v AstraZeneca — Trixeo prescribing summary card (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3683/8/22
Parties	Complainant v AstraZeneca
Product	Trixeo (formoterol fumarate dihydrate, budesonide, glycopyrronium)
Material	Prescribing summary card on a named publisher’s website (GB-37784; Date of preparation: July 2022)
Main allegations	Spacer wording implied any spacer; deposition % claim not transparent/estimated; missing Symbicort prescribing information
Applicable Code	2021
Clauses considered	2, 5.1, 6.1, 6.2, 11.2, 12.1
Outcome	No breach of the Code
Panel note/concern	Panel queried appropriateness of comparative claims against an unlicensed product not marketed or available anywhere in the world; requested AstraZeneca be advised of concerns
Complaint received	11 August 2022
Case completed	19 September 2023
Appeal	No appeal

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

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An anonymous, contactable complainant (health professional) complained about a Trixeo (formoterol fumarate dihydrate, budesonide, glycopyrronium) prescribing summary card hosted on a named publisher’s website (GB-37784; date of preparation: July 2022).
The complainant alleged three issues: (1) the card said patients could use Trixeo Aerosphere “with a spacer” (complainant said only Aerochamber was licensed); (2) the card claimed “Trixeo’s innovative Aerosphere technology enables 38% to 41% deposition” (complainant said these were estimates based on functional imaging and not transparent); (3) a comparative claim referenced “formoterol/budesonide MDI**” and the complainant alleged Symbicort prescribing information was missing.
AstraZeneca said the card was developed from content it provided, in a format developed by the host publisher; AstraZeneca commissioned and funded it and stated it carried out full medical approval.
AstraZeneca argued: (1) the Trixeo SPC refers to “a spacer” and does not restrict use to Aerochamber (it only states compatibility with Aerochamber Plus Flow-Vu has been demonstrated); (2) lung deposition methods are estimates and the 38–41% range reflected published data; (3) the formoterol/budesonide MDI comparator was not Symbicort and was an unlicensed regimen not marketed in the UK (footnote stated “**This regimen is not licenced in the UK”), so Symbicort PI was not required.

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No breach found in relation to the “spacer” claim: no breach of Clauses 11.2, 6.1, 6.2, and consequently no breach of Clauses 5.1 and 2.
No breach found in relation to the “38% to 41% deposition” claim: no breach of Clauses 6.1, 6.2, and consequently no breach of Clauses 5.1 and 2.
No breach found in relation to alleged omission of Symbicort prescribing information: no breach of Clause 12.1, and consequently no breach of Clauses 5.1 and 2.
The Panel nevertheless queried whether comparative claims against an unlicensed product not marketed or available anywhere in the world were appropriate, and asked that AstraZeneca be advised of its concerns.

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Clause 2 — Requirement that activities or materials must not bring discredit upon, or reduce confidence in, the pharmaceutical industry (No breach)
Clause 5.1 — Requirement to maintain high standards at all times (No breach)
Clause 6.1 — Requirement that claims must not be misleading (No breach)
Clause 6.2 — Requirement that claims must be capable of substantiation (No breach)
Clause 11.2 — Requirement that a medicine must be promoted in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics (No breach)
Clause 12.1 — Requirement to include up to date prescribing information (No breach)

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