Cephalon: Uncertified Effentora launch training materials and inadequate representative training (AUTH/2232/5/09)

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Key facts

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Case number	AUTH/2232/5/09
Parties	Anonymous former representative v Cephalon
Product	Effentora (fentanyl buccal tablet)
Issue	Training of representatives; certification of briefing materials; adequacy and documentation of training
Applicable Code year	2008
Complaint received	22 May 2009
Case completed	06 July 2009
Appeal	No appeal
Breach clauses	1.7, 9.1 (x2), 14.1, 15.9, 16.1 and 16.2
Sanctions	Undertaking received; Additional sanctions: Not stated

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

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An anonymous former Cephalon representative complained about training for representatives promoting Effentora (fentanyl buccal tablet), focused on the Effentora launch meeting (12–15 January 2009).
Allegations included: limited face-to-face Code training; managers allegedly advising staff to be careful what they recorded in the customer database and suggesting telephoning “off-label targets” to avoid being seen.
The complainant alleged training materials lacked job bag numbers/dates and were therefore not copy approved/certified (including slide sets, role play materials, and an AV presentation shown as a “concept”).
The complainant queried whether certain materials should have included the black triangle.
As part of the Effentora Risk Management Plan, representatives were required to provide an Effentora Prescribing Guide on the first call; the complainant alleged staff were trained on an uncertified copy and were not trained on when to use it.
The complainant also alleged lack of training on hospitality/speaker fees, grants/donations, medical and educational goods and services, and auditing of expenses.
Cephalon provided information on SOPs and guidance documents, and stated a Code compliance project was underway.

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Breach found for use of uncertified representatives’ briefing/training materials at the launch meeting.
Breach found for failure to maintain high standards due to the failure to certify much of the training material before use.
Breach found for inadequate training arrangements (need for more focused and validated training; lack of documentation of training and pharmacovigilance training records).
Breach found for non-compliance with the Code.
No breach for black triangle requirement (materials were not shown to have been used with health professionals; Clause 4.11 applies to promotional material).
No breach for alleged failures around training on the Prescribing Guide (Panel accepted representatives had been trained).
No breach for failure to appoint a senior employee responsible for Code compliance (general manager appointed).
No breach for alleged off-label promotion/targeting (complaint not proved on balance of probabilities; Panel noted concern about lack of clear instructions).
No breach of Clause 2 (Panel did not consider circumstances warranted it).

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