UK pharma regulator names Bayer, Astellas and A Menarini in ads over breaches 'discrediting' pharma industry

The self-regulatory body for the UK pharma industry will name four pharmaceutical firms in advertisements in trade press over breaches of the ABPI code, three of which related to Clause 2 breaches.

The Prescription Medicines Code of Practice Authority today published information on reprimands after rulings relating to Bayer, Astellas, A Menarini's and Sunovion's breaches of the code.

Astellas, which has already been reprimanded this year over use of its patient support materials by an agency and suspended by the ABPI, made two voluntary admissions - one by its UK business and one by its European arm.

Astellas UK admitted that "over a long period of time, a large number of its promotional materials which referred to two medicines failed to include the prescribing information for both of those medicines", and admitted that it did not act immediately once the problem was discovered, a PMCPA release said.

Astellas Pharma Europe's admission was that an electronic advertisement for a drug "incorrectly referred to an indication and a publication as new". Both it and the UK business were deemed to have breached several parts of the ABPI code including Clause 2, 'Bringing discredit upon, and reducing confidence in, the pharmaceutical industry'.

A Menarini's breach of Clause 2 and other clauses related to its failure to provide information to the public on its website about a 'yellow card' it had been given by the Medicines and Healthcare products Regulatory Agency, and failing to act on this omission.

Bayer breached the code in three places, including Clause 2, having produced training and briefing material which suggested an unlicensed use for one of its drugs.

Sunovion did not breach Clause 2 but was guilty of two breaches after staff were encouraged to suggest to customers that there might be legal consequences if they did not consider its drug as part of a patient review. Sunovion has also been reprimanded for providing inaccurate and misleading information to the PMCPA during the investigation process.

Advertisements describing the breaches will appear in the British Medical Journal on 16 December, the Nursing Standard on 13 December, and the Pharmaceutical Journal on 16 December. This is a standard reprimand measure for the PMCPA.

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