GSK rep wears dunce cap for off-label breach in U.K.

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It's the sort of code-of-practice violation that doesn't typically make headlines outside of the trade press. But this time, it's the context that counts. Just months after CEO Andrew Witty vowed to stamp out marketing missteps, GlaxoSmithKline ($GSK) was slapped on the hand by the U.K.'s self-governing pharma board for a sales rep's off-label promotion.

The sales rep apparently emailed a National Health Sevice consultant about using the company's Revolade drug to treat myeloid fibrosis, an off-label use. According to the Prescription Medicines Code of Practice Authority (PMCPA), the rep's activities breached the industry's code.

"The panel considered that the representative should have been mindful of the impression given by the subject matter of the email and noted the representative's acknowledgement that it could have been misconstrued," the PMCPA said (as quoted by The Guardian). "High standards had not been maintained in this regard by the representative and a breach of the code was ruled."

The PMCPA said that there was "no evidence the company had failed to maintain high standards." So, GSK was cleared of a more serious charge--that it brought discredit upon the pharma industry, The Guardian said.

GSK said that the company "never intended to promote our medicines for unauthorized indications but we can see how the [email] could have been misconstrued especially if taken out of the context in which it was written," The Guardian reports. "We need to always be mindful of what audiences might infer from emails or other communications, even if that isn't what we intended." The company said it's "implementing further training" to make sure it doesn't happen again.

The code violations follow a record-breaking $3 billion settlement with the U.S. Justice Department involving off-label marketing of several drugs, including the antidepressant Paxil. When the settlement was announced, Witty said the company's mistakes were "unacceptable" and that he was "very sorry" about them. Just last week, North American pharma chief Deirdre Connelly said GSK had learned its lesson. Perhaps that lesson hasn't made its way through the ranks quite yet.

- read the Guardian piece

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