← Back to Cases
PMCPA Case

Syner-Med ruled in breach over misleading Ferinject dosing and comparative infusion-time claims

📅 2008 | 🖉 Dr Anzal Qurbain
đź“Š

Key facts

⌄
Case numberAUTH/2149/8/08
Case referenceFreelance medical writer v Syner-Med
ComplainantFreelance medical writer
Respondent/companySyner-Med (Pharmaceutical Products) Limited
Product(s)Ferinject (ferric carboxymaltose); comparator referenced: CosmoFer (iron (III))
Material/channelDetail aid, two-page brochure, leavepiece distributed at British Renal Society meeting (May 2008)
Key issueMisleading dosing presentation; misleading comparative infusion-time claims; missing prescribing-information signposting; unclear date of preparation
Dates (received/completed if stated)Complaint received 24 July 2008; case completed 21 August 2008
AppealNot stated
Code year2008 Code (clauses cited stated as same in 2008 as in 2006)
Breaches/clausesClause 7.2; Clause 4.8; Clause 4.9
SanctionsNo explicit additional sanctions stated beyond the required undertaking/corrective actions described in the report

Download the full case report (PDF)

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
đź“‹

What happened

⌄
  • A freelance medical writer complained about promotional material for Ferinject (ferric carboxymaltose) distributed by Syner-Med (Pharmaceutical Products) Limited at the British Renal Society meeting in Glasgow on 13/14 May 2008.
  • Materials at issue: a 12-page detail aid (“The next generation intravenous iron”, ref F07/01-05-08-039), a two-page brochure (“Anaemia Service… Redesigning Provision”, ref F09/07-05-08-045) and a leavepiece (“The next generation intravenous iron”, ref F08/06-05-08-044).
  • Dosing concern: the detail aid prominently stated “Up to 1000mg… Dose in 15 mins” and “allows for 1000mg to be given in 15 mins”, while the qualifying limit “should not exceed 15mg/kg” appeared separately as a footnote on another page.
  • Comparative claim concern: the materials claimed “Reduces infusion time… 6 hrs to 15 mins” (and the brochure presented “Time to Deliver i.v. Iron Dose” data) referenced to CosmoFer SPC; the complainant argued CosmoFer infusion time in the SPC was 4–6 hours.
  • Prescribing information concerns included: no reference to where prescribing information could be found (detail aid and leavepiece), alleged need for a statement to consult the SPC for other side effects, legibility/line length, and missing/unclear date of preparation.
⚖️

Outcome

⌄
  • Detail aid (dosing): The Panel ruled the dosing presentation was misleading because important qualifying information was separated and the dosing was “not straightforward” per the SPC; breach ruled.
  • Detail aid (CosmoFer comparison): The “6 hrs to 15 mins” claim was ruled misleading because it referred only to the maximum duration for CosmoFer total dose infusion; breach ruled.
  • Detail aid (prescribing information location): Breach ruled because there was no reference to where prescribing information could be found (acknowledged by Syner-Med).
  • Detail aid (side effects statement): No breach: the side effects listed were the complete list from the SPC, so no need to add a statement to consult the SPC for other side effects.
  • Detail aid (legibility/line length): No breach: although line length was around 150 characters (above the recommended 100), the Panel considered it legible (on the limits of acceptability).
  • Detail aid (date): Breach ruled because the date of preparation was not obvious/understandable to the reader (a code was used).
  • Brochure: The CosmoFer “time to deliver” comparison was ruled misleading for similar reasons; breach ruled. No breach on side-effects statement or line length; breach ruled for date of preparation.
  • Leavepiece: The CosmoFer comparison claim was ruled misleading for similar reasons; breach ruled. Breach ruled for no reference to where prescribing information could be found and for date of preparation; no breach on side-effects statement.
🔒

Unlock the full case analysis

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

Best value
ÂŁ249/year
Annual — save £99
or
ÂŁ29/mo
Monthly
Join Now — Instant Access
← All Cases Book a Free Compliance Call

⭐ Charter Member — Until 31 March

See the full compliance picture for every pharma company

291 Company Intelligence Reports — breach patterns, appeal history, industry ranking, PDF export. £1,999/year £2,499

Get Charter Access →

📰 Weekly PMCPA Case Breakdown

One real case. One key lesson. Every week — free.

Subscribe Free