Vifor and Grünenthal ‘Named and Shamed’ for Breaking ABPI Code
Pharmaceutical companies Grünenthal and Vifor have been ‘named and shamed’ in numerous publications for breaking the Association of the British Pharmaceutical Industry’s (ABPI’s) Code of Practice.
Grünenthal has been criticised for the way in which their team of health economic liaison managers drove interest in and awareness of their unlicensed pain reliever treatment, tapentadol.
The Medicines and Healthcare products Regulatory Agency (MHRA) had formerly given the organisation a warning after they communicated about the product’s budgetary implications to approximately 3,000 healthcare professionals prior to it being cleared for market by regulators.
But afterwards an unspecified source claimed that Grünenthal continued to contact numerous health professionals, with set call rates and supportive materials, to use in ‘proactive discussions’ with doctors.
The MHRA was concerned that Grünenthal was persistently promoting their unlicensed painkiller drug, tapentadol, but with the lack of any proof of actual promotion they did not think it fitting to take forward a legal investigation, and so passed the case on to the Prescription Medicines Code of Practice Authority (PMCPA).
After an enquiry by the Prescription Medicines Code of Practice Authority, Grünenthal was ruled to be in 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 organisation has also received a public warning for providing “misinformation in its response to recommendations following an audit.”
Vifor Press Releases
In Vifor’s case, the firm was named and shamed for failing to conform with an undertaking by leaving two press releases on their website with related claims to material that had previously been ruled in breach of the ABPI’s Code of Practice.
Both press releases on the website in October 2011 claimed that their iron deficiency treatment Ferinject “avoids dextran-induced hypersensitivity reactions,” which complainant Pharmacosmos AS alleged mistakenly implies that the product is free from hypersensitivity reactions.
The organisation had already been ruled in breach of the ABPI’s Code of Practice by using the same statement on a leavepiece for prescribers, as the PMCPA considered that in the absence of a counter-balancing statement about the potential 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.”
As the following press releases also failed to address these criticisms, 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.
Links:
www.pharmatimes.com