Abbott voluntary admission: Synagis email deemed promotional, uncertified and included off-licence recommendation (AUTH/2171/9/08)

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Key facts

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Case number	AUTH/2171/9/08
Company	Abbott Laboratories Limited
Product	Synagis (palivizumab)
Material/channel	Email to health professionals with attached committee letter and pasted JCVI text
Main issue	Promotional email/attachment not certified and without prescribing information; included off-licence recommendation; emailed without documented/express permission for at least one recipient
Applicable Code year	2008
Breach clauses	3.1, 4.1, 9.1, 9.9, 14.1 and 15.2
Clause 2	Not breached (Panel decided not to rule a breach)
Complaint received	06 October 2008
Case completed	18 November 2008
Appeal	No appeal
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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Abbott voluntarily admitted that a sales representative sent an email about Synagis (palivizumab) to a number of health professionals that breached the ABPI Code.
The email followed a meeting where HCPs requested a link to JCVI website guidance on palivizumab.
The representative also attached a letter from a medicines management committee to a specialised commissioning lead about regional policy/consensus on palivizumab use.
The representative copied and pasted text from the JCVI website into the email, including recommendations for palivizumab.
The email and attached letter were considered promotional when distributed by a representative with a commercial interest.
No prescribing information was included and the email/attachment had not been formally certified.
The pasted JCVI text included a recommendation for use in “children under 2 years of age with severe congenital immuno-deficiency”, which was outside the Synagis SPC.
The representative said recipients had given permission to be emailed, but no documentation was provided; additionally, a lead pharmacist was copied in without her permission.
Abbott stated the representative had been briefed on email use and had recently completed Code refresher training; Abbott planned rebriefing and internal disciplinary proceedings.

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Breach rulings: Clauses 3.1, 4.1, 9.1, 9.9, 14.1 and 15.2.
No breach of Clause 2 (Panel decided, on balance, not to rule Clause 2 given the context and limited distribution).
Case treated as a complaint because issuing uncertified material and promoting outside the marketing authorisation were considered serious.
No appeal.

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