GlaxoSmithKline has been found guilty of three breaches of the ABPI Code after an unnamed company employee made a complaint about off-label promotion of its platelet drug Revolade.
The drug giant was found in breach of Clause 3.2, which says that companies cannot market a drug outside of its licence; Clause 15.2 which says that pharma reps must maintain ethical standards and comply with the Code; and Clause 9.1, which states that pharma firms must maintain high standards.
The GSK employee, who has not been named, said a company rep had been promoting Revolade for the unlicenced indication myeloid fibrosis to an NHS consultant via email and in subsequent meetings. The drug is currently approved for the treatment of immune (idiopathic) thrombocytopenic purpura (ITP).
The email read: “Request for an appointment re an [individual funding request] submission for a patient with Myeloid Firosis [sic]”.
The email did not expressly refer to Revolade, but was part of a series of communications about the drug, and the funding request was in relation to GSK’s medicine.
The PMCPA, which polices the Code, said it considered that the representative “should have been mindful of the impression given by the subject matter of the email”, and noted the rep’s defence that the email’s heading “may have been misconstrued”.
But the PMCPA found that high standards had not been maintained, that the ethical standards of the rep had also not been maintained, and that the firm was guilty of promoting the drug off-label.
GSK was not, however, found guilty of breaching Clause 2 of ‘bringing the industry into disrepute’, which is seen as the most serious element of the Code. It was also not found in breach regarding other allegations from the employee about staff training on lung drug Seretide and Parkinson’s disease treatment ReQuip XL.