Product Labels: Comments Before FDA

Written by Joseph Brodine, MD, NPA FDA Task Force Member

Comments at FDA Meeting to Discuss Proposed Rule that Would Allow Manufacturers of Generic Medications to Autonomously Update Their Product Label

On March 27, 2015, the FDA held a public meeting to discuss a proposed rule first published in the November 13, 2013 Federal Register that would allow manufacturers of generic medications to autonomously update their product label (aka Prescribing Information or “PI”) while subsequently submitting the changes for FDA approval. If the FDA approves the labeling changes, all other manufactures of the equivalent drugs (including the brand drug if still in production) would be required to update their labels within 30 days. This stands in contrast to the current conditions in which generic manufactures have no timely mechanism to institute a label change and are not allowed to update their drug PIs without FDA approval. There is also no time limit currently in existence, so if a brand drug manufacturer updates its PI, there can be a significant time lag (on the order of years) until the generic manufacturers are told to update their labeling.

The aim of this rule is two-fold: improve patient safety by creating a mechanism for timely updates to drug labels and it would allow the generic manufacturers to be liable for damages caused by their product if they fail to provide adequate warning on the labeling. Currently, patients who are injured by generic drugs have no legal recourse, a status upheld as result of two landmark Supreme Court cases.

The aim of the public meeting was to “provide a public forum for FDA to listen to comments” from stakeholders regarding the proposed rule and any alternatives. The comment period is currently open and will extend until April 27, 2015.

Click here to read more of Joseph Brodine’s comments before the FDA.