Labelling and generics: who is accountable?

On 12 April 2016, a group of 15 healthcare stakeholders wrote to the US Food and Drug Administration (FDA) expressing concerns that the FDA Proposed Rule to change generic drug label requirements could create provider and prescriber confusion and add significant avoidable costs to an already strained healthcare system.¹

Nearly 8 in 10 prescriptions filled in the US are for generic drugs. The use of generics is expected to grow during the next few years as a number of popular drugs come off patent.² Under regulations by the FDA, generic drugs must be chemically equivalent, have the same active ingredients and be bioequivalent to their branded counterparts.

However, the onus for safety monitoring appears to rest on the innovator, whose label is the Reference Listed Drug (RLD). Most notably, while a branded drug manufacturer is responsible for the accuracy and adequacy of its drug label, a generic drug company is responsible for ensuring that its label is the same as the label of the brand-name RLD.

Of several labelling regulations expected this year, the one with the greatest impact would be the proposed rule regarding labelling of generic drugs by the US FDA. The proposed rule asks generic drug companies to update their labels with new safety information as their reference product counterparts have done for almost 30 years. The FDA announced recently that this much-debated rule would be released in late 2016, but the different generic stakeholders are protesting against it.