AUTH/2131/6/08: Community pharmacist v Grünenthal Ltd – interim data used to support comparative claims for Versatis | PMCPA Case

📊

Key facts

⌄

Case number	AUTH/2131/6/08
Case reference	2131 (November 2008 report)
Complainant	Community pharmacist
Respondent/company	Grünenthal Ltd
Product(s)	Versatis (lidocaine medicated plaster)
Material/channel	Representative call; detail aid (pages 4, 5 and 8 referenced)
Key issue	Use of interim “data on file” and other sources to support specific 4-week comparative efficacy and adverse event claims vs pregabalin (and discussion also referenced gabapentin); substantiation and misleading presentation
Dates (received/completed if stated)	Complaint received 10 June 2008; Case completed 29 August 2008
Appeal	Not stated
Code year	Not stated
Breaches/clauses	Clauses 7.2 and 7.4 breached; Clause 7.5 not breached
Sanctions	No explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

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

🤖

Got a question about this case?

Ask one of our 13 specialist ABPI advisors — instant answers, 24/7.

Ask AskAnzal AI

📋

⌄

A community pharmacist complained about a Grünenthal representative’s promotion of Versatis (lidocaine medicated plaster) during a pharmacy visit in June 2008.
The representative said a study showed Versatis had roughly equivalent efficacy to gabapentin (and/or pregabalin) with a much lower incidence of interactions and side-effects.
The complainant asked to see the data and was told it was incomplete and might be available in September; the representative did not later offer to supply information in September.
The complaint focused on the use of interim data in a detail aid to support claims such as “Versatis is comparable to pregabalin in patient response at 4 weeks” and similar 4-week pain and adverse event comparisons.
Grünenthal said the pharmacist wanted the full trial data when complete (not interim data) and provided electronic call notes made after the visit.
The Panel reviewed the detail aid pages (including pages 4, 5 and 8) and the substantiation provided (including “data on file”, interim analysis, and references to Hempenstall et al (2005) and SPC information).

⚖️

⌄

No breach was found for failure to supply interim data because the Panel did not consider there was sufficient evidence that the complainant had asked for interim data (Clause 7.5 not breached).
The Panel ruled that comparative efficacy claims versus pregabalin at 4 weeks were not substantiated by the interim data provided and were misleading.
The Panel ruled that specific 4-week adverse event comparison claims versus pregabalin were not substantiated; SPC information was considered too general to support the specific 4-week claims.
Breaches of Clauses 7.2 and 7.4 were ruled in relation to the comparative claims supported by interim data.
The Panel asked that its concerns about whether Hempenstall et al was sufficient to substantiate comparative claims be drawn to Grünenthal’s attention.

📖

⌄

Clause 7.2 – Breached (comparative claims for efficacy and adverse events vs pregabalin at 4 weeks not substantiated; misleading).
Clause 7.4 – Breached (comparative claims considered misleading/insufficiently substantiated in the context of the interim data and specific 4-week claims).
Clause 7.5 – Not breached (insufficient evidence that interim data had been requested; therefore no breach for failure to supply interim data).

🔒

Members get the complete breakdown — Clauses, Sanction, Signatory Lens, Audit checklist, and 3 Key Questions.

Best value

£249/year

Annual — save £99

£29/mo

Monthly

Join Now — Instant Access