GMC guidance on off-label drug use delayed

pharmafile | March 19, 2012 | News story | Sales and Marketing GMC, Lucentis, avastin, off label, off-label, prescribing 

The General Medical Council has delayed the release of new guidance for off-label prescribing.

The doctors’ regulator was expected to have published its guidance on the issue late last year.

But a GMC spokeswoman told Pharmafocus that draft guidance would now be sent to the regulator’s council on 17 April, four months later than planned.

The guidance has taken so long because the GMC has been unable to reach an agreement on a number of key points – but the spokeswoman would not give any further details on what these points were.

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This is a highly contentious issue for pharma and in June, the ABPI said prescribing a drug off-label when a licensed alternative exists “increases patient safety risks and threatens the development of new medicines”.

A high profile example involves Roche’s Avastin (bevacizumab) being used off-label by ophthalmologists for the eye disease wet AMD, instead of Novartis’ Lucentis (ranibizumab).

The drugs are chemically similar, but off-label use of Avastin is much cheaper than Lucentis.

The GMC is looking at off label use because doctors are coming under increasing pressure by the NHS to make savings, whilst also looking to make the best clinical decision for patients.

But these two may not tally up as there are concerns that off-label prescribing could endanger patients’ lives, as they have not been tested for the indication being used.

In some cases there are no alternatives for using off-label drugs – such as with rare diseases – but doctors are also prescribing off-label drugs where a licenced drug is already on the market, such as the case with Avastin and Lucentis.

The pharma industry argues that this practice is being used to saved money, and this is not always in the best interests of the patient. 

The doctors’ regulator is now aiming to clarfiy its position on the practice, and is looking to make specific changes to its ethical guidelines in an effort to make off-label use clearer for doctors.

Pharmafocus will publish further details about the guidance next month.

Ben Adams

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