FDA Reopens Comment Period on Generic Drug Labeling Proposed Rule

Jordan L. Lipp | Partner, Davis Graham & Stubbs LLP

Bowing to pressure from stakeholders and Congress, on Tuesday FDA announced that it would reopen the comment period (through April 27, 2015) for its proposed rule that would allow generic drug manufacturers to unilaterally change their labels.  And, FDA set a public meeting for March 27, 2015, in order to “provide a public forum for FDA to listen to comments on the proposed rule.”  As discussed in more depth in an earlier post, FDA’s highly controversial proposed rule would permit generic drug manufacturers to unilaterally change their labels under changes-being-effected (“CBE”) process, which not only would result in the potential for generic and brand-name labels to differ, but would also threaten to undermine recent generic drug preemption decisions by the U.S. Supreme Court.

FDA noted in its announcement that it received comments “proposing alternative approaches to communicating newly acquired safety-related information in a multisource environment,” and that in light of a request from trade associations and Congress for a “listening meeting” to consider such alternatives to the proposed rule, it would be holding the public meeting and reopen public comment.  These alternative approaches are based upon the fact that FDA has greater access to all the available data than any individual manufacturer.  As such, the alternative approaches set forth a system for an expedited agency review of newly acquired drug safety information, as opposed to the CBE process, so that FDA can determine if labeling changes are required.

FDA’s statement, as well as information for submitting comments and/or registering for the public meeting, is set forth here.