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

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If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.

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).

As the generic-drug label needs to be identical to the RLD, largely generic-drug manufacturers are immune to liability in failure-to-warn cases as can be seen in the PLIVA, Inc. vs. Mensing ruling (2). They do not have to engage in rigorous safety tracking, unlike the innovator pharma companies. Under the new ruling, generic-drug manufacturers would have to track any new safety information and update their labels by filing a CBE-0, instead of remaining identical to the RLD. Therefore, they could be held accountable in failure-to-warn cases.

Creating efficient operations
If the proposed rule goes ahead, generic-drug companies will have to strengthen their pharmacovigilance operations-from assessing safety signals to ensuring label compliance. If the rule is passed, generic-drug companies will need documented processes for safety tracking and updating labels.  For innovator companies, drug labeling is a complex and collaborative process combining multiple sources into a label. In addition to this, the local labeling information for different geographic locations is created from a global core data sheet. The complexity increases when the local labeling documents are in differing languages with different content. The labeling development process is resource-intensive, requiring input from regulatory, safety, legal, clinical, manufacturing, and other teams.


A streamlined safety and labeling workflow would help generic-drug companies to cope with the extra safety tracking. A possible solution would be to outsource the end-to-end labeling process, which includes document management, version control, and standardization of the labeling process.


  1. Office of Information and Regulatory affairs, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products“ www.reginfo.gov/public/do/eAgendaViewRule?pubId=201604&RIN=0910-AG94,  accessed July 11, 2016.
  2. Epstein Becker Green, “FDA Rule Providing Generic Manufacturers with the Ability to Unilaterally Update Safety Labels May be Abandoned” www.lexology.com/library/detail.aspx?g=6e97e27d-0ec7-4077-b274-a1e192ecb562 accessed July 11, 2016.
  3. Zachary Brennan “Updated: Congress Looks to Force FDA Into Rewriting Major Generic Drug Labeling” http://raps.org/Regulatory-Focus/News/2016/04/13/24750/Updated-Congress-Looks-to-Force-FDA-Into-Rewriting-Major-Generic-Drug-Labeling-Rule/, accessed July 11, 2016.

About the author

Bindu Narang is director of Scientific Writing and Regulatory Affairs at Sciformix Corporation, Bindu.Narang@Sciformix.com.