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PMCPA Case

CCG v Thame Laboratories: threatening, misleading letter promoting Thamicarb and invoking MHRA

📅 2015 | 🖉 Dr Anzal Qurbain
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Key facts

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Case numberAUTH/2971/8/17
ComplainantTwo members of staff from a Clinical Commissioning Group (CCG)
CompanyThame Laboratories Ltd (Syri Ltd trading as Thame Laboratories)
Product(s)Thamicarb Oral Solution (sodium bicarbonate 1mmol/ml); comparator referenced: Sodibic Oral Solution (food supplement). Similar letter referenced by complainant: Syrisal (sodium chloride 1mmol/ml oral solution) (not ruled on in this complaint).
MaterialLetter to clinician dated 2 August 2017 urging prescribing of Thamicarb and refraining from Sodibic; included MHRA references and “vigorously prosecute” wording.
Main issuesMisleading promotion; omission of licensed indication/age limits; implied blanket switching; misleading MHRA implication; threatening/disparaging tone; high standards; regulator reference not specifically required.
Applicable Code year2016
Breach clauses2, 3.2, 7.2, 7.4, 8.2, 9.1, 9.5
Complaint received17 August 2017
Undertaking received15 February 2018
Appeal hearingNo appeal (Appeal Board consideration of case report under Constitution and Procedure)
Appeal Board consideration22 March and 18 April 2017 (as stated in the report)
Additional sanctionCorrective statement required to all recipients (Paragraph 11.3)
Corrective statement issued11 June 2018
Distribution (reported)Thamicarb: 200 letters to CCGs and 195 letters to GP practices/surgeries (not individual GPs). Syrisal: 200 letters to CCGs and 196 letters to GP practices/surgeries.

Download the full case report (PDF)

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

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What happened

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  • Two CCG staff complained about a letter Thame Laboratories sent to a clinician about prescribing Sodibic Oral Solution (sodium bicarbonate) as a food supplement instead of Thamicarb Oral Solution (Thame’s product and the only licensed prescribed medicine form of sodium bicarbonate).
  • The letter urged the recipient to ensure Thamicarb was prescribed and to refrain from prescribing Sodibic.
  • The letter referenced MHRA guidance and stated Thame had been advised by the MHRA to report findings, and that Thame would “vigorously prosecute” any “non-compliance” to the MHRA risk framework, requesting a response within 15 days.
  • Complainants alleged the letter was bullying/threatening, misleading about Thamicarb’s licence (not stating its licensed indication/age limits), implied MHRA had commissioned Thame to identify/report practices, and inappropriately challenged clinical decision-making without patient context.
  • Thame said the letter was intended as a non-promotional legal communication, was sent outside SOP due to misunderstanding, and would not have been approved if routed through the approval process.
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Outcome

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  • The Panel ruled the letter was promotional (not merely regulatory guidance).
  • The Panel ruled the letter was misleading (including implying broad licensed use and implying patients could be switched without considering clinical circumstances).
  • The Panel ruled the MHRA references were not specifically required and were misleading in implying MHRA had formally requested Thame to identify/report practices.
  • The Panel ruled the tone/content disparaged health professionals’ clinical opinion and failed to maintain high standards.
  • The Panel ruled the letter brought discredit upon and reduced confidence in the industry.
  • The Appeal Board considered the issues serious and imposed an additional sanction requiring a corrective statement to all recipients of the letter at issue.
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