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"Off-label" covers a variety of situations. Applications for Marketing Authorisations [MAs] -licenses, leading to a "label"- are made by companies. They do this for almost entirely commercial reasons. In the particular instance of bevacizumab for macular degeneration the company sees no reason to apply for an MA since they make the much more expensive product that is licensed.
This could be seen as a failure of the whole of the licensing system in that it relies on companies to do things in the best interests of patients because these are coincident with their commercial interests. In this situation, the assumption is false.
The GMC and the author of this letter make a mistake if they apply a blanket disapproval of ALL unlicensed indications. If it were open (practically as well as legally) to the NHS to apply for an MA then bevacizumab would very likely become licensed in this indication, but with pressure from companies and their allies to prevent this, the opportunities to bring benefits to more patients will be lost.
(Although I am a member of the Pharmacovigilance Working Party at the European Medicines Agency this is strictly a personal view)
Re: Prescribing bevacizumab off-label contravenes GMC advice
"Off-label" covers a variety of situations. Applications for Marketing Authorisations [MAs] -licenses, leading to a "label"- are made by companies. They do this for almost entirely commercial reasons. In the particular instance of bevacizumab for macular degeneration the company sees no reason to apply for an MA since they make the much more expensive product that is licensed.
This could be seen as a failure of the whole of the licensing system in that it relies on companies to do things in the best interests of patients because these are coincident with their commercial interests. In this situation, the assumption is false.
The GMC and the author of this letter make a mistake if they apply a blanket disapproval of ALL unlicensed indications. If it were open (practically as well as legally) to the NHS to apply for an MA then bevacizumab would very likely become licensed in this indication, but with pressure from companies and their allies to prevent this, the opportunities to bring benefits to more patients will be lost.
(Although I am a member of the Pharmacovigilance Working Party at the European Medicines Agency this is strictly a personal view)
Competing interests: No competing interests