AbbVie: complaint about Synagis discussion at BPD Masterclass (AUTH/3050/6/18) – no breach | PMCPA Case

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Key facts

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Case	AUTH/3050/6/18
Complainant	Anonymous, non-contactable health professional
Company	AbbVie Ltd
Medicine	Synagis (palivizumab)
Issue	Alleged interrogation about prescribing habits and discussion of immunising infants outside JCVI guidance and product licence (“namely twins”) at a BPD Masterclass
Setting	Day-long BPD Masterclass meeting at a hotel in London (May 2018)
Applicable Code year	2016
Clauses considered	3.1, 3.2
Outcome	No breach
Complaint received	28 June 2018 (HTML) / 29 June 2018 (PDF)
Case completed	14 November 2018
Appeal	No appeal

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

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An anonymous, non-contactable health professional complained about a day-long BPD (bronchopulmonary dysplasia) Masterclass held in May 2018, organised and funded by AbbVie, which discussed Synagis (palivizumab).
The complainant alleged one session was cut short and an AbbVie representative used the time to “forcefully interrogate” the audience about prescribing habits and views on immunising infants outside JCVI guidance and the product licence, “namely twins”.
AbbVie said the relevant session was likely “The Real Impact of RSV – Think About What You Can’t See”; the speaker finished early (about 35 minutes vs 60 allocated) and the remaining time was audience Q&A.
AbbVie stated the representative answered AbbVie-specific questions (eg pricing) and facilitated discussion including use of Synagis in premature twins/multiples, limited to use within the licence.
The Panel noted the Code requires promotion to be consistent with the marketing authorisation/SPC; it does not require promotion to be consistent with JCVI guidance (though information must be accurate and not misleading).

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No breach of the Code was found.
The Panel ruled the complainant had not provided evidence that Synagis was promoted outside its licensed indication as alleged.
No breach of Clauses 3.1 and 3.2 was ruled.

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