Proposed FDA Rule Allows Generic Drug Manufacturers to Update Labeling

November 13, 2013

After much anticipation, the U.S. Food and Drug Administration (FDA) has taken action to place responsibility on generic drug manufacturers to provide adequate warnings to consumers, and hold them legally liable for their failure to do so.  Currently, federal law requires generic drug labeling to match that of their brand-name counterpart, and as a result the Supreme Court held in PLIVA v. Mensing that failure-to-warn claims cannot be brought against the generic drug-maker.  The seeming injustice resulting from this has been a source of controversy and advocacy over the years.  Taking a significant step forward to protect consumers, the FDA has made public a proposed rule on generic drug labeling that could effectively overturn Mensing and provide legal remedy those that have been injured after consuming a generic drug.

The FDA’s proposed rule would allow generic drug manufacturers to initiate changes to their own labeling by submitting a CBE (changes being effected) supplement.  Currently, they cannot initiate those changes on their own and must wait for their brand-name counterpart to do so.  In drafting this rule the FDA illustrates their awareness that not only does the current law leave many consumers without legal recourse, but it fails to create any incentive for generic manufacturers to work in coordination with the FDA to market and label their products safely.  Taking into account that there is little incentive to comply with post-market requirements and ensure that their labels are accurate and up to date, this proposed rule was designed to “create parity” between generic and brand-name manufacturers.  Allowing generic manufacturers to unilaterally initiate changes to product labeling could eliminate the preemption of failure-to-warn clams related to generic drugs.

This proposed rule is not official yet.  First, there is a 60 day time-period where comments can be submitted on the proposed rule.  After this time, the FDA will review the comments and publish a final rule.  This issue is extremely important, and a final rule allowing these changes could potentially protect the legal rights of generic drug users which accounts for over 80% of all prescriptions filled in the United States.  It also ensures that generic drug-makers are responsible and accountable for their products.  The American Associate for Justice is a primary group promoting the implementation of this rule.  To continue their advocacy on this issue, they have created a petition that you can access and participate in by clicking here.


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