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