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The Ethics Around Drug Labels and Generic Medicines

The labels of off-patent medicines can be obsolete and even misleading when compared to the contemporary, evidence-based use of the medicine. Apart from serious adverse drug reactions that can lead to rapid changes to the label, regulatory agencies can only review and approve proposed changes to the label submitted by the sponsor of the medicine. There are many reasons why a sponsor may not wish or have incentive to submit proposed changes, particularly once a medicine is off-patent. The problem of misleading and potentially dangerous medicines labels post-patent expiry needs to be addressed. Consideration is needed of the roles of the label at patent expiry, how well that role is fulfilled and the possible alternatives. Our preference is for a ‘partnership’ approach to support production and maintenance of up to date, and relevant information for generic medicines that is pragmatically situated within the context of other sources of high quality information and advice. Reform is clearly needed but progress will be dependent on convincing stake-holders of that need and will require much lateral and innovative thought from all stakeholders best facilitated by an ‘honest broker’ such as the DIA. The importance of drug labels A medicine is more than a pill, solution for injection or a topical product. It includes at least as significantly, the medicines information that optimizes the chance for safe and effective therapy in individual patients. This information is contained within the product ‘label’, ‘approved product information’ [PI] or ‘summary of product characteristics’ [SPC]— henceforth referred to as the ‘label’. The label, which is the Regulatory agency’s officially approved information document, accompanies each registered medicine. Despite these expectations, for reasons that will be discussed below, it is unavoidable that the longer a drug has been available on the market the more the official information in the label is likely to be obsolete, less relevant or even misleading. Furthermore, information for the patient, for example the corresponding patient information that is derived from the ‘label’, may also be inconsistent with the contemporary use of the medicine or the indication/s for which the medicine is being prescribed. Labels or consumer information that are not up-to-date and consistent with contemporary, evidence-based practice can, therefore, lead to stress and uncertainty for clinicians or patients who want to make use of this information.