Colonis Pharma Limited has been sanctioned by the Prescription Medicines Code of Practice Authority over a promotional letter for its Melatonin 1mg/ml Oral Solution product.
The PMCPA ruled the letter breached multiple clauses of the industry code, including the most serious charge of bringing discredit upon the pharmaceutical sector.
A pharmacist working within a medicines optimisation team submitted the original complaint, alleging the letter blatantly promoted off-label use of the melatonin product.
The medicine carried a licensed indication only for the short-term treatment of jet lag in adults, yet the letter focused overwhelmingly on other uses.
The PMCPA Panel found that while the licensed indication did appear in the letter, it was a single reference and the rest of the content discussed use of the medicine in preference to unlicensed alternatives.
Critically, the letter contained no warning to alert readers that Melatonin 1mg/ml Oral Solution should not be used in children and adolescents, raising serious patient safety concerns.
The Panel ruled that patient safety had been compromised by the promotion of off-label use, determining that a breach of Clause 2 had occurred as a result.
Colonis also voluntarily admitted to including incorrect prescribing information in the same letter, with text relating to Melatonin 3mg Film-Coated Tablets appearing under the Melatonin 1mg/ml Oral Solution heading.
The company was found in breach of Clause 3.2 for promoting an unlicensed indication, Clause 4.1 for failing to include accurate prescribing information, and Clause 9.1 for failing to maintain high standards.
The Code of Practice Appeal Board went further, issuing a public reprimand against Colonis for its failure to provide complete and accurate information to the Code of Practice Panel during proceedings.
The case highlights the PMCPA’s continued willingness to pursue pharmaceutical companies that blur the boundaries between licensed and unlicensed uses of medicines in promotional materials.
Promotional communications that minimise licensed indications while directing healthcare professionals toward unapproved uses represent a clear regulatory risk, as this ruling demonstrates.
Patient safety obligations extend beyond the content of licensed indications and require companies to proactively flag contraindications, particularly where vulnerable groups such as children are involved.
The ruling serves as a reminder to pharmaceutical marketing teams that even procedural failures, such as including incorrect prescribing information, can attract significant regulatory censure.