FDA to Hold March Meeting, Reopen Comment Docket on Generic Label Proposal

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Feb. 17 — The Food and Drug Administration will hold a public meeting March 27 on a proposed rule from 2013 on procedures generic drug companies would use to change their labels to reflect new safety information.

The meeting in the agency's White Oak office in Silver Spring, Md., will provide a public forum on the proposed rule on “changes being effected” supplements to labels that was published in November 2013 (78 Fed. Reg. 67,985, Nov. 13, 2013), the agency said in a notice set for publication Feb. 18 in the Federal Register.

The agency also is reopening the comment period (docket number FDA-2013-N-0500) on the proposal. Comments are due April 27. The agency said it is asking for comments on the proposal as well as on the “alternative proposals” presented during the March meeting.

In the notice, the agency said its proposed rule, “if finalized, would enable abbreviated new drug application (ANDA) holders for generic drugs to update product labeling promptly to reflect certain types of newly acquired safety-related information, irrespective of whether the revised labeling differs from that of the corresponding reference listed drug (RLD or brand drug)” upon submission of a changes being effected supplement to the FDA. The proposed revisions to allow generic manufacturers to update product labeling through CBE supplements “in the same manner as brand drug manufacturers are intended to improve communication of important, newly acquired drug safety information to health care professionals and the public.”

The proposed rule (RIN 0910–AG94) has been the subject of criticism from the generic drug industry and others, and the agency said in fall 2014 it was delaying the release of a final version until the end of September 2015.

In early 2014 comments to the FDA, generic drug manufacturers, pharmacists and drugstores said they have concerns with the agency's proposed generic drug labeling rule, including the possibility of additional litigation faced by makers of generic drugs. Meanwhile, consumer groups and patient advocates said the proposed rule would allow patients and health-care providers to have the most up-to-date safety information on generic products.


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