AUTH/2505/5/12: Anonymous v ProStrakan — Abstral off-label promotion allegation (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2505/5/12
Parties	Anonymous v ProStrakan
Product	Abstral (fentanyl) sublingual tablets
Issue alleged	Off-label promotion to a burns unit; comparison with competitor fentanyl lozenge (Actiq) without supporting data
Complainant	Anonymous, non-contactable; worked in a specialist burns unit
Complaint received	10 May 2012
Case completed	22 June 2012
Applicable Code year	2011
Clauses considered	2, 3.1, 9.1, 15.2, 15.9
Panel decision	No breach (complaint not established on balance of probabilities)
Appeal	No appeal
Notable Panel comment	Concern that MLEs responded to burns-related requests apparently without relevant training; urged urgent review of role and training

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

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An anonymous, non-contactable complainant working in a specialist burns unit alleged a ProStrakan “medical liaison specialist” promoted off-label use of Abstral (fentanyl) sublingual tablets.
Abstral’s stated indication was breakthrough pain in adults using opioids for chronic cancer pain.
The complainant said they agreed to the meeting because the visitor presented as medical liaison (not sales).
The complainant alleged the visitor showed only breakthrough cancer pain data (not burns/off-label data) and discussed speed of action in the context of dressing changes/movement.
The complainant alleged the visitor questioned them about prescribing a competitor fentanyl lozenge (Actiq) and compared the two products, but provided no supporting data for use in burns patients.
ProStrakan stated its medical liaison executives (MLEs) only discussed off-label use reactively in response to unsolicited requests, and proactive/off-label discussion was prohibited.
ProStrakan said that between Feb 2011 and May 2012 it received 432 requests to respond to HCPs; only three related to Abstral use in burns patients and all were prompted by HCP requests.
ProStrakan stated there were no training materials/briefing documents produced for the MLE team about Abstral use in burns patients.

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No breach of the Code was ruled.
The Panel found the complainant had not established the case on the balance of probabilities, noting the complainant was anonymous/non-contactable and provided no supporting material.
The Panel expressed concern that MLEs had responded to requests about burns patients apparently without relevant training, and said ProStrakan should urgently review the MLE role and training in relation to Code requirements.

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