Alert February 20, 2015

FDA Revisits Its Proposed Rule Regarding Generic Drug Labeling


On February 18, 2015, the FDA announced that it is reopening the comment period for its proposed rule that would allow ANDA holders to unilaterally update their generic drug product labels prior to the NDA holder doing so. The comment period closes on April 27, 2015. The FDA will also hold a public webcast on March 27, 2015 regarding its proposed rule.

On February 18, 2015, the FDA issued a notice announcing that it is seeking further comments on its November 2013 proposed rule that would allow ANDA holders to update their product labels for safety reasons via the CBE-0 process, in advance of the reference listed drug manufacturer doing so. The February 18 notice announces that the FDA is reopening the comment period for the proposed rule until April 27, 2015, and that there will be a webcast “public meeting” regarding the proposed rule on March 27, 2015. The notice contains details as to the comment period and the public webcast. According to the FDA, the webcast is being held for a number of reasons, including “to promote transparency,” and to address requests from two trade associations for a meeting to present alternatives to the proposed rule. The final rule is expected in September 2015, if at all.

The FDA’s plan to reopen the comment period and hold a webcast, together with certain public comments made by FDA representatives, suggest that the final rule could end up being significantly different from the original proposal published in November 2013. The generic pharmaceutical industry has opposed the FDA’s original proposed rule as inconsistent with the requirements and purpose of the Hatch-Waxman Act. The original proposed rule would permit multiple competing labels on drugs that are chemically and biologically equivalent, likely resulting in confusion among prescribers and patients. The lack of consistency inherent in the original proposed rule would also likely result in an increase in costs and litigation.

Generic pharmaceutical companies should consult with experienced counsel as to whether they should consider submitting a comment prior to the close of the extended comment period, as well as to stay abreast of any developments concerning the FDA’s proposed rule.

The complete FDA notice can be found here.

Carla Rose Karp ( contributed to the preparation of this alert.