GSK guilty of off-label promotion
GlaxoSmithKline has been found to have breached three clauses in the ABPI Code of Practice following a complaint from a member of its own staff.
The case concerned the off-label promotion of blood disorder drug Revolade (eltromopag), with GSK falling foul of clause 3.2 (‘the promotion of a medicine must be in accordance with the terms of its marketing authorisation’).
While cleared of the most serious Code breach (clause 2’s discredit to the pharma industry) the company was found guilty of failing to maintain high standards at all times (clause 9.1).
The GSK employee complained that a GSK representative had promoted the unlicensed use of Revolade - which is indicated for immune (idiopathic) thrombocytopenic purpura (ITP) - in myeloid fibrosis.
The complaint stemmed from an email sent by the rep to a consultant about an individual funding request (IFR) for a patient and, as a result GSK was deemed to have contravened clause 15.2, which deals with reps’ ethical conduct.
The subject line of the email read: “Request for an appointment re an IFr submission for a patient with Myeloid Firosis [sic]”. The email referred to a phone conversation with the consultant’s secretary and suggested dates to: “discuss putting together the IFR for your patient with Myeloid Fibrosis”.
GSK said the consultant had asked the rep for information about Revolade to support a funding request for a patient with chronic ITP. While the subsequent meeting was indeed about an IFR for the use of Revolade in chronic ITP, the rep acknowledged that the email subject could have been misconstrued.
The email did not expressly refer to Revolade, but was part of a series of communications about the drug, and the IFR referred to was in relation to Revolade.
Although there was no evidence that the meeting itself was unacceptable, the email implied that the IFR related to Revolade and its use in myeloid fibrosis - and was therefore promoting Revolade outside its licensed indication.
The PMCPA said the rep should have been mindful of the impression given by the subject matter of the email.
Other complaints from the same employee about staff training on Seretide (fluticasone/salmeterol) and ReQuip XL (ropinirole) were not upheld.