Draft Guidance Allows Limited Generic Label Changes
A 7/11 FDA draft guidance would allow ANDA holders to update drug labels with new safety information if the reference-listed drug (RLD) has been withdrawn by the branded manufacturer. Attorney Bradley Davidsen (Epstein Becker Green) writes in an online analysis that the draft represents a limited compromise between the agency and drug companies over the broader issue of updating generic drug labels.
Davidsen notes that FDA issued a proposed rule in 2013 to give generic drug manufacturers much broader powers and responsibilities over the labels of the drugs they manufacture. It led to significant controversy within the industry, resulting in multiple delays in finalizing the proposed rule and action by the House and Senate appropriations committees to approve budgets specifically banning spending on the proposed rule. The proposal is not likely to be seen again until at least summer of 2017, he says.
The new draft focuses on changes to generic drug labeling under a much narrower set of circumstances in which the NDA of the RLD has been withdrawn by the manufacturer for reasons other than safety or efficacy. The draft says that the “changes being effected” mechanism available to NDA holders can be used by an ANDA holder with a withdrawn RLD if changes become necessary based on new safety information it obtains.
The draft also describes other sources of information available to an ANDA holder with a withdrawn RLD to aid in determining whether a label should be updated. The agency suggests that the manufacturer review the labels of other NDA and ANDA drugs with the same active ingredient as they may have been updated more recently than the RLD label at the time it was withdrawn.
According to Davidsen, the avenue for updated labeling in the draft resembles the concept of expedited agency review (EAR) included in an alternative to the 2013 proposed rule developed by the Generic Pharmaceutical Association and Pharmaceutical Research and Manufacturers of America.
“While the draft guidance only applies to a very small and specific set of generic labels,” the attorney writes, “the similarities between EAR and FDA’s process for updating the label of an ANDA with a withdrawn RLD demonstrates cooperation between FDA and industry to at least find common ground on the issue of generic labeling. While the recommendations set forth in the draft guidance may be a sign that FDA is willing to listen to industry suggestions, the draft guidance’s impact is too limited to predict whether FDA will continue to search for a middle ground with the remaining generic labeling issues raised in the proposed rule.”