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PMCPA: Sanofi ‘discredited pharma’

pharmafile | October 28, 2013 | News story | Medical Communications, Sales and Marketing ABPI, PMCPA, Sanofi, breach 

Sanofi has lowered the public’s confidence in the pharma industry, according to the PMCPA, which enforces the ABPI Code of Practice.

Novo Nordisk complained to the PMCPA that a press release on Sanofi’s website regarding Lyxumia (lixisenatide) breached the undertaking given by Sanofi in an earlier case.

The PMCPA concurred after investigating the matter, and decided that Sanofi had broken the most serious clause of the Code, clause 2, which says companies’ activities “must never be such as to bring discredit upon, or reduce confidence in, the pharmaceutical industry”.

The PMCPA says the judgment “is a sign of particular censure” and has also ruled that Sanofi has breached the catch-all clause 9, which states: “High standards must be maintained at all times.”

Breaking an earlier undertaking is dealt with by clause 25, which means Sanofi has breached three clauses of the Code in all – the PMCPA emphasised that it was “very important for the reputation of the industry that companies complied with undertakings”.

The case (AUTH/2619/7/13) concerns an advert which claimed ‘Lyxumia leads to even greater costs savings’ and ‘Turn to the GLP-1 that minimises costs’. 

Novo said these claims did not take into account the differences in efficacy and safety between Lyxumia and similar treatments – and Sanofi had agreed to amend them.

A press release issued after this included the line: ‘Lyxumia is a new, cost-effective option….’ and the PMCPA decided that ‘cost-effective’ implied savings beyond the acquisition cost alone – something which should have been made clear, and was sufficiently similar to problems identified in the earlier case (AUTH/2604/5/13) to constitute a breach of undertaking.

The PMCPA decided on the three breaches – against which the company is not appealing – and the details will be published in the November 2013 Review.

Adam Hill

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