PMCPA rules on two Bayer conduct breach allegations
pharmafile | November 20, 2015 | News story | Medical Communications, Sales and Marketing |Â Â Â
The pharma industry regulator in the UK, the PMCPA, has ruled on two alleged breaches of the ABPI code of conduct from German company Bayer.
The Prescription Medicines Code of Practice Authority ruled that Bayer had breached certain sections of the code in each complaint, brought by an anonymous consultant and an anonymous, non-specified complainant.
The consultant’s complaint concerned the company’s promotion of the neovascular (wet) age-related macular degeneration (wAMD) injection treatment Eylea (aflibercept) , and that Bayer employees had mislead him/her to believe that Eylea was superior to Novartis’ Lucentis, although the comparison was not like-for-like, due to the comparison dose of Lucentis being unlicensed in the UK.
The complainant was concerned that other consultants would be similarly misled and that a forthcoming meeting would promote the unlicensed 0.3mg dose of Lucentis.
The panel noted issues with the 18-month time-frame the complainant alleged discussions with Bayer over the treatment had taken place, and failed to find evidence that the Bayer representative had not maintained a high standard of conduct.
However, the company was found guilty of a breach of clauses 7.2, 7.3, 15.2, 15.9 and 9.1, due to certain sections of information in an e-detailer used in Eylea marketing being misleading regarding comparative trial data.
The second alleged breach was raised by anther anonymous individual, who claimed further misleading marketing of a Bayer product- specifically concerning a leavepiece for the preventative stroke and systemic embolism therapy Xarelto (rivaroxaban).
The complainant drew attention to a table in the leavepiece which compared Xarelto favourably to two other NOACs (novel oral anticoagulants) from Eliquis/Bristol-Myers Squibb and Boehringer Ingelheim, when there had been no head-to-head trials.
Although a small footnote attempted to justify this, the complainant believed the explanation was too small and easily missed, and that the company should have been clear about the comparison and trials.
The PMCPA panel agreed that the information as presented was misleading, and ruled breaches of clauses 7.2 and 7.3 of the ABPI code of conduct, which relate to misleading Information, claims and comparisons.
Joel Levy
