Pharmaceutical companies Grünenthal and Vifor Pharma UK are being 'named and shamed' in various publications for breaching the Association of the British Pharmaceutical Industry's Code of Practice.
In Grünenthal's case, the company has been rebuked for the manner in which its team of health economic liaison managers fueled interest in and awareness of its unlicensed painkiller tapentadol.
The Medicines and Healthcare products Regulatory Agency had previously given the firm a slap on the wrist after its team contacted 3,000 healthcare professionals about the product’s budgetary implications before it was cleared for market by regulators.
But subsequently an anonymous source alleged that Grünenthal continued to target health professionals, with set call rates and supporting materials - including slides - to use in "proactive discussions" with doctors.
The MHRA was concerned that Grünenthal was continuing to promote its unlicensed painkiller tapentadol to healthcare professionals, but in the absence of any evidence of actual promotion it did not consider it appropriate to take forward a legal investigation, and so passed the case to the Prescription Medicines Code of Practice Authority (PMCPA).
After an investigation by the PMCPA, the firm was ruled breach of the ABPI's Code of Practice for: bringing discredit upon, and reducing confidence in, the pharmaceutical industry; promoting a medicine before marketing approval; and failing to maintain high standards.
The company has also received a public reprimand for providing "misinformation in its response to recommendations following an audit".
Failure to comply with undertaking
In Vifor Pharma's case, the company was reprimanded for failing to comply with an undertaking by leaving two press releases on its website with similar claims to material that had previously been ruled in breach of the Code.
Both press releases on the company's website in October last year used the claim that its iron deficiency treatment Ferinject "avoids dextran-induced hypersensitivity reactions", which complainant Pharmacosmos AS alleged wrongly implies that the product is free from hypersensitivity reactions.
The company had already been ruled in breach of the Code by using this statement on a leavepiece for prescribers, as the PMCPA considered that in the absence of a counter-balancing statement about the possibility of hypersensitivity reactions with Ferinject, the information provided "sought to minimise the prescriber's concerns about such reactions and in that regard might compromise patient safety".
The fact that the subsequent press releases also failed to address these criticisms meant that Vifor was again ruled in breach of the following clauses: bringing discredit upon and reducing confidence in the pharmaceutical industry; failing to maintain high standards; and failing to comply with an undertaking.
Advertisements describing both Grünenthal and Vifor's breaches have already appeared in the British Medical Journal and The Pharmaceutical Journal this week, and are due for publication in The Nursing Standard tomorrow (July 11).