Generic Drug Labeling: FDA Provides Guidance For Label Updates

July 12, 2016

Just over five years ago, in June 2011, the U.S. Supreme Court decided PLIVA, Inc. v. Mensing,[1] a case which has served to buffer generic drug makers from failure-to-warn lawsuits. In short, the Court held that federal drug regulations applicable to generics preempt state law claims and require that generic labeling must always be the same as that of the brand-name drug. Since generic drug makers are required to match the labeling of the brand-name version of the drug, PLIVA established that the generic manufacturers cannot be sued for not warning about potentially dangerous side effects on their drugs because of their inability to independently update labels.

Currently, brand-name drug makers can change or update their labeling without Food and Drug Administration (“FDA”) approval when presented with new safety information, but generic drug makers are not free to independently update their labels. While generic drugs are required to mirror their brand-name counterparts at the time of approval, sometimes the generic drugs rely on drugs that have been withdrawn from the market for economic reasons.

On Friday, July 8, 2016, the FDA issued a draft guidance document which lays out when drug makers should update the label for a generic drug when its reference product (or “RLA”–the original drug on which the generic is based) is withdrawn for reasons other than safety or effectiveness.

The FDA draft guidance document noted that “all holders of marketing applications for drug products [] have an ongoing obligation to ensure their product labeling is accurate, and not false or misleading. When new information becomes available that causes the labeling to become inaccurate, false or misleading, the application holder must take steps to update its labeling.”[2]

Where the New Drug Application (NDA) for the RLA has been withdrawn, generic drugs that were based on the withdrawn drug may continue to be marketed. As these drugs are used over time, the scientific community’s understanding of the drug may evolve as new published literature and postmarketing data becomes available. Therefore, this labeling may eventually become inaccurate and outdated, resulting in labeling that is false or misleading. The FDA’s proposal would allow generic drug makers to submit proposed label updates to the FDA. The FDA provided several examples of when a label update might be needed, such as “revising the adverse reactions section to include a new adverse reaction based on postmarketing experience.”[3]

It is possible that this proposed change may provide a foothold for Courts to find that generic drug manufacturers are liable for injuries caused by their failure to update warnings. However, the FDA has proposed similar rule changes–designed to allow some freedom for generic labeling updates—in the past, and drug industry lobbyists have stopped those prior labeling proposals in their tracks. Time will only tell whether these new proposed rule changes suffer the same fate.

There is a 60-day public comment period for the FDA’s draft guidance.

Photo Credit: RoguePlanet

[1] PLIVA, Inc. v. Mensing, 564 U.S. 604 (U.S. 2011).
[2] See “Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn.”
[3] Id.


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