FDA’s Proposed Generic-Drug Labeling Rule: Ensuring Efficiency and Compliance

September, 2016
Author: Bindu Narang, Sciformix Corporation

The highly debated FDA generic-drug labeling rule, which was due to be passed in July 2016, has been further delayed and is now expected to be finalized in early 2017 (1). The ruling, first unveiled in 2013, has received significant criticism from many healthcare stakeholders, with trade groups for generic-drug manufacturers continuing to fight any finalization of the ruling (2).

Currently, generic-drug labels have to be identical to the innovator reference listed drug (RLD) label. It is the branded manufacturers (RLDs) who are responsible for updating labels with new safety information and the accuracy and adequacy of the information on these labels. The proposed rule would change that—generic-drug companies would be responsible for updating their labels, based on their own pharmacovigilance activities whenever new safety information is detected.

One concern is that the rule could potentially cause confusion for physicians prescribing generic drugs, as multiple manufacturers updating labels separately could create different and possibly conflicting safety information. The US Congress, however, wants the final version of the rule to state that FDA must pre-approve any changes to the safety information in the labeling of a drug and an identical change be made by the RLD (3). This stipulation would require the proposed rule to be rewritten, creating the possibility that the bill may be completely abandoned (2).

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