Four pharmas breach ABPI Code of Practice

by | 17th Dec 2013 | News

Allergan, Shire Pharmaceuticals, Gedeon Richter and Sanofi have been found guilty of breaching the ABPI Code of Practice and bringing discredit upon, and reducing confidence in, the pharmaceutical industry.

Allergan, Shire Pharmaceuticals, Gedeon Richter and Sanofi have been found guilty of breaching the ABPI Code of Practice and bringing discredit upon, and reducing confidence in, the pharmaceutical industry.

Allergan has also been publicly reprimanded by the ABPI’s Code of Practice Appeal Board, for a run of breaches relating to its failure to comply with an undertaking by continuing to claim that its Vistabel/Botox (onabotulinumtoxin A) was clinically more potent than Merz’ product Bocouture/Xeomin (incobotulinumtoxin A).

Merz claimed that at a meeting, and through one of its representatives, Allergan continued to misrepresent data relating to the relative potencies of the two rival medicines, despite rulings in previous cases that it should not do so.

Shire fell foul of the Code for distributing a journal reprint containing an incorrect and misleading comparison between Shire’s Replagal (agalsidase alfa) and Genzyme’s product Fabrazyme (agalsidase beta), and for not ensuring that readers were aware of the error.

In February 2010 Shire gave an undertaking not to deliberately refer to or use an unsubstantiated, misleading and incorrectly favourable bar chart which compared Replagal with Fabrazyme. This chart was subsequently corrected in the Lancet in 2010, but in December 2012 Shire reproduced the uncorrected bar chart in a promotional piece.

The Prescription Medicines Code of Practice Authority (PMCPA), the policing arm of the ABPI, ruled that the company had indeed breached the Code by making misleading claims, making a misleading comparison, making claims incapable of substantiation, and bring discredit upon the industry.

Elsewhere, Gedeon Richter was reprimanded for inappropriate use of twitter, after an events company engaged by the firm sent out a tweet essentially promoting the prescription only medicine Esmya (ulipristal acetate) to the public.

And finally, Sanofi was founding breach of five clauses after one of its representatives persuaded an NHS administrative assistant to send a promotional email via NHS.net to local GP practices, inviting recipients to view a promotional webcast for the firm.

In a separate case brought by Novo Nordisk, Sanofi failed to comply with a previous undertaking by using a claim in a press release on Lyxumia (lixisenatide) regarding its cost effectiveness, similar to one previously ruled in breach of the Code.

The Nursing Standard, the BMJ and The Pharmaceutical Journal will all carry advertisements later this week outlining the relevant breaches of the Code.

Tags


Related posts