US FDA’s Generic Labeling Rule: A Brief Overview

Bindu Narang

This year promises to be a very happening year as far as rule making for labeling is concerned. Several labeling regulations are anticipated this year. However, the most impactful would be the proposed rule regarding labeling of generic drugs by the US FDA. The US FDA announced recently that this much-debated rule would be released in July 2016.

To understand why this proposed rule has caused so much discussion, we need to understand the labeling process for generic drugs. Today the US FDA specifically requires that the generic product have the same label as the reference listed product. This implies that even if the drug manufacturer is aware of any safety concern, the label of the generic product cannot be updated unless the reference listed product label is updated. This supports the business model of the generic drug companies since they need to update their label only at the trigger of update of a reference listed product and don’t need to engage themselves in rigorous safety tracking like an innovator pharma company. This also largely granted the generic manufacturers immunity from being held accountable for not communicating key safety information to the consumer (“failure to warn”).

The proposed rule, once finalized would permit a generic manufacturer to update the labels on receipt of new safety specific information. The generic manufacturer will be able to file a CBE-0 in order to update the label. CBE-0 refers to a regulatory procedure by which a manufacturer would make changes to the registered information (a label in this case) immediately by notifying the changes to the FDA in parallel. This would mean that post filing the CBE-0, even though same in every other aspect, the label for the reference listed and the generic drug will differ for a “temporary period” while the regulatory mechanisms work to ensure that eventually the label of the reference listed and the generic drug are aligned. And this would also mean that the update of the label may have happened without the FDA adequately reviewing and approving the labeling changes.

This rule thus may make the generic manufacturers accountable in ‘failure-to-warn’ cases and thereby encourage the generic manufacturers to track the safety of their product more rigorously. Given the impact that the finalization of this proposed rule would have, it has met with strong reactions from the industry. There have been more than 23,700 comments on this rule. One of the prominent concerns of the generic manufacturers has been that the ‘identical nature’ of the generic drug to the reference listed drug has been the reason for physicians to use the generic drugs with confidence. More than 80% of the US prescriptions are for generic drugs. Also, the generic manufacturers opine that the proposed rule would increase healthcare costs for consumers and government agencies owing to the requirement of enhanced safety tracking. Updating the labels of generic drugs without scrutiny from US FDA and lack of complete product data may also be the other limitations.

As the implementation of the rule nears, the US FDA itself will need to sort out a legal deadlock that arises owing to the conflict between the proposed rule and the concept of generics as described in the Hatch Waxman act. Making it clear that the rule would be rolled out later this year, it is sure that all these hurdles will be solved. From a patient’s perspective this is definitely a step in the positive direction in terms of equipping the consumers with most updated safety information, but at the same time may have an implication of increased cost to the consumers. For the generic manufacturers this rule is a compelling reason for safety tracking and implementing processes for safety label updates.