Pharma’s Off-Label Violations Not Limited to the U.S.: Glaxo’s U.K. Flap

At a time when GlaxoSmithKline (GSK) execs have been arguing that off-label promotional activity is no longer standard operating procedure, they must have been chagrined to learn that a Glaxo employee earlier this year complained to the UK trade group for the pharmaceutical industry that promotional and training efforts involving sales reps crossed the line.

In a ruling issued last week, the Association for the British Pharmaceutical Industry found that Glaxo violated the code of conduct three different ways in connection with a promotional push for the Revolade treatment for a rare bleeding disorder known as immune thrombocytopenic purpura, or ITP.

The unnamed Glaxo employee complained that a sales rep had promoted Revolade for myeloid fibrosis to an National Health Service consultant through e-mails and meetings. And the panel ruled that the communications, which referred to both maladies involving a particular patient, could have been misconstrued and the rep should have known better.

Big Pharma -- companies including Pfizer (PFE), Novartis (NVS), Merck (MRK) and Sanofi (SNY) -- is having a hard time generating revenue growth, due to patent expirations on existing drugs and a failure to develop enough new drugs.

GSK Revenue TTM Chart

GSK Revenue TTM data by YCharts

Moreover, the panel also noted that the language in the e-mail sent by the rep was actually provided by the Revolade brand team, suggesting that the confusing language was part of a deliberate campaign to promote the drug for an unapproved use. Consequently, the drugmaker violated the code, although not the section that brings the industry into disrepute.

To read the remainder of this article, go to Pharmalot.

Ed Silverman is the editor of Pharmalot and a contributor to YCharts, which includes the just-released YCharts Pro Platinum for professional investors.



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