FDA Request for Comments on Timing For Implementation of Safety Labeling Changes


Source: Sidley Austin LLP

On December 20, 2011, the U.S. Food and Drug Administration (FDA) published a notice requesting public input on the deadlines for implementing drug safety labeling changes.  FDA’s request refers specifically to the timeframes in which manufacturers should implement safety labeling changes and the circumstances in which it is appropriate for products with existing labeling to remain in distribution when a labeling change is made.  Because the frequency of labeling changes and the flexibility in the regulatory system for the implementation of such changes over time can have significant commercial implications, manufacturers should review the notice and consider options for providing comment.  FDA’s request acknowledges the practical implications of safety labeling changes, including with respect to drug manufacturing, packaging, printing, and supply chain issues.  FDA specifically requests comments on eight questions:

  1. What are the considerations related to drug manufacturing and packaging, of which FDA should be aware, as they relate to implementation of revised product labeling?
  2. What are the considerations related to printing labels and other types of labeling of which FDA should be aware, as they relate to implementation of different types of revised product labeling?
  3. What are the supply chain factors (including storage, shipping, and distribution factors) of which FDA should be aware that limit or otherwise affect how quickly a labeling change can be implemented?
  4. What alternative labeling mechanisms (e.g., having labeling available on a product Web site) could be used to disseminate new safety information quickly to patients and health care providers?
  5. How should the relative seriousness of the new safety information, or whether the new safety information describes a newly identified risk, or strengthens a risk already identified in current labeling, affect timelines for implementing revised product labeling?
  6. What are the implementation considerations when the safety labeling change is to prescriber versus patient labeling (or both)?
  7. What would be a reasonable timeframe following approval of revised safety related labeling changes for applicants to implement the revised labeling?  Please relate this timeframe to the optimal point in the supply chain (e.g., newly manufactured product, newly shipped product) and the type of labeling change.
  8. Are there other considerations or options related to implementing safety labeling changes of which FDA should be aware?

The full request is available here.  Comments are due by February 21, 2012.

If you have any questions regarding this update, please contact Coleen Klasmeier (+1.202.736.8132,, Torrey Cope (+1.202.736.8803,, or the Sidley lawyer with whom you usually work.

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