AUTH/2971/8/17: CCG v Thame Laboratories – threatening, misleading letter promoting Thamicarb | PMCPA Case

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Key facts

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Case number	AUTH/2971/8/17
Parties	Clinical Commissioning Group v Thame Laboratories Ltd (Syri Ltd trading as Thame Laboratories)
Product(s)	Thamicarb Oral Solution (sodium bicarbonate 1mmol/ml); comparator referenced: Sodibic Oral Solution (sodium bicarbonate) as a food supplement
Material	Letter to a clinician dated 2 August 2017
Main issue	Promotional letter urging switch/cessation of Sodibic; misleading MHRA references; implied illegality; disparaging/threatening tone; omission of licensed indication/limitations
Complaint received	17 August 2017
Applicable Code year	2016
Breach clauses	Clause 2; Clause 3.2; Clause 7.2; Clause 7.4; Clause 8.2; Clause 9.1; Clause 9.5
Panel view on promotion	Letter was promotional under Clause 1.2 definition (urged prescribing Thamicarb and refraining from Sodibic)
Sanctions	Undertaking received; additional sanction: corrective statement to all recipients (issued 11 June 2018); advertisement listed
Completion	18 April 2018 (case completed at Panel level; Appeal Board considered additional sanctions)
Review publication	August 2018

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

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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 stated sodium bicarbonate solution was a medicinal product and could not be presented as a food supplement/nutritional product, and referenced MHRA’s position that food supplements should be avoided when licensed prescription products are available.
The letter urged the recipient to ensure Thamicarb was prescribed and to refrain from prescribing Sodibic, and demanded a response within 15 days, otherwise “all such steps deemed necessary” would be taken.
The letter stated Thame would “vigorously prosecute” any “non-compliance” with the MHRA risk framework and included wording implying MHRA had advised Thame to report practices dispensing food supplements against prescriptions.
Complainants alleged the letter was bullying/threatening, inappropriately challenged clinical decision-making, implied Thamicarb was licensed for broader use than it was (it did not state the licensed indication/age restriction), and misleadingly suggested MHRA had commissioned Thame to identify/report prescribers.
Thame said the letter was intended as a non-promotional legal communication, was sent outside its SOP approval process due to misunderstanding, and apologised for the tone.

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The Panel ruled the letter was promotional (it urged switching to Thamicarb and stopping Sodibic).
The Panel ruled the letter was misleading in multiple respects (licence implications, switching implication, MHRA implication, illegality implication).
The Panel ruled the letter disparaged the professional opinion of the health professional and failed to maintain high standards.
The Panel ruled the threatening tone and MHRA/legal implications brought discredit upon the industry.
The Appeal Board considered the issues serious and imposed an additional sanction requiring a corrective statement to all recipients.

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