The consequences of the Supreme Court’s decision in Pliva v. Mensing continue to play out on multiple tracks.  Most recently, the FDA has reopened the comment period for its proposed rule that would allow generic drug manufacturers to unilaterally update their warnings labels.  The proposed rule would change the result in the Pliva decision which held that certain failure to warn claims against generic drug manufacturers are preempted, while those same claims against brand-name drugs are not.  In order to level the field and provide plaintiffs a way to sue generic drug manufacturers, the FDA proposed greater authority (and liability) for generic drug manufacturers over the content of their warning.  Interested parties have until April 27 to weigh in on the consequences of this rule and make suggestions for how the rule could be improved.

The Current State of the Rules

Currently, different rules exist for generic drug manufacturers (GDM) and brand-name drug manufacturers (BNM) with regard to their warning labels.  Generally speaking, GDMs and BNMs must obtain FDA approval before making changes to their warning labels.  However, under certain circumstances, BNMs, and only BNMs, may use the Changes Being Effected (CBE) supplement process to unilaterally alter their warning labels without first obtaining FDA approval.  If the FDA approves a BNM’s label change, GDMs must make that same change to the corresponding generic drug’s label as soon as possible.  If, however, a GDM wishes to include a warning that is different or stronger than its brand name equivalent, it must first obtain FDA approval – the CBE supplement process is not available to it.

Because GDMs are unable to independently alter their label to reflect newly acquired information about the effects of their drug, the Pliva Court held they cannot be liable for failing to make such changes.

How Things Could Change

In response to this decision, the FDA proposed a new rule that would make three major changes to existing regulations.

  • First, the rule would open the CBE supplement process up to GDMs, allowing them to make changes to their label before obtaining FDA approval
  • Second, under the new rule, the FDA would maintain a website containing the information submitted by GDM’s about their proposed label changes. GDMs that submit CBE supplements would be required to monitor the information posted on the website and notify the FDA if any of the information is incorrect within five days of it being posted.
  • Third, the new rule would impose a 30 day requirement for GDMs to update their labels to match those of the brand-name equivalent. Currently, the rule provides that, once the FDA approves a label change to a brand name drug, GDMs must make that same change to the corresponding generic drug as soon as possible.  An “as early as possible” deadline gives GDMs much more leeway to implement the change in a timeframe that’s amenable to them.  A strict 30-day deadline, however, would require GDMs to implement these changes quickly and may open them up to liability if they fail to do so.

During the initial comment period, the FDA received multiple comments about the impact this rule could have on the availability of generic drugs, the increased litigation costs, and the additional burden the rule would place on physicians.  After reviewing this feedback, the FDA has decided to reopen discussion about the rule and its potential impacts on the public, the pharmaceutical industry, and other interested groups.  Comments may be submitted to: http://www.regulations.gov (search Docket No. FDA-2013-N-0500-0081) through April 27, 2015.  Additionally, for those interested in making a public appearance, the FDA will host a public meeting on March 27, 2015 from 8am to 5 pm in Silver Spring, Maryland.  Interested parties may register by emailing CBESupplements.PublicMeeting@fda.hhs.gov by March 20, 2015.  For more information, please visit: http://www.regulations.gov/#!documentDetail;D=FDA-2013-N-0500-0081

For more information about the proposed rule and a link to the full text, see: https://www.federalregister.gov/articles/2013/11/13/2013-26799/supplemental-applications-proposing-labeling-changes-for-approved-drugs-and-biological-products