Originally Published PMPN June 2002
REGULATORY FOCUS
Electronic Labeling SubmissionsFDA cites speed and accuracy as benefits of electronic submissions for labeling.
Erik Swain, Senior Editor
Until now, FDA has encouraged electronic submissions and issued guidance on how to provide them, but it never made them compulsory. That has changed with a proposed rule, published in the May 3, 2002, Federal Register [67 FR:22367– 22375], requiring electronic submission of labeling for many prescription drug and biological products.
The rule would require the content of all labeling under 21 CFR 100(d)(3), including all text, tables, and figures, to be submitted electronically. The requirement that the actual labeling be submitted on paper would remain. The reasons, FDA says, are that it wants to cut back on the potential for error that can occur during manual review of side-by-side comparisons of old and new labeling, and to speed up the process. The agency says it receives more than 1000 proposed labeling changes for approved brand-name prescription drugs and biologics and more than 2600 proposed original and supplemental labeling changes for generic drugs. It conducts a word-for-word comparison of the proposed labeling with the last approved labeling (and for generic drugs, with both the previous generic labeling and the reference listed drug labeling). Using paper copies makes the process slow and subject to error, the agency says.
Electronic submissions would enable FDA to quickly identify changes in the new labeling and "shorten the time needed to approve labeling changes and reduce the amount of resources we need to devote to labeling review." Electronic review and comparison will also "provide a higher degree of certainty that all portions of prescription drug labeling are accurate." And in circumstances in which the agency reviews changes in labeling after they have been implemented and finds the changes inappropriate, it could reduce the amount of time the inadequate labeling is available to the public.
The rule suggests the electronic submissions should be in PDF format, because the agency already uses it widely in a manner that can be processed, reviewed, and archived, and it allows word-for-word comparisons. PDF files can be created from any number of programs and can be printed in original form. In addition, PDF software is commercially available for a low price, which will keep costs down for applicants. However, in case a better technology emerges in the future, the wording of the proposal does not specify that the submissions must be in PDF format, only that they should be in a format that the agency can process, review, and archive. If FDA ever recommends other software or file formats, it will do so in a future guidance.
The electronic submissions should be sent in accordance with the most recent guidelines: They should not have headers or footers other than page numbers; they should not have columns that interfere with the copy and paste functions; they should come in an "easily read" font size; they should have "portrait" page orientation; and their page size should be large enough to print efficiently but small enough to be printed on a standard page.
The rule also calls for the deletion of references to other specific nonpaper media in the regulations, including microfiche, microform, optical disk, and magnetic tape.
It also proposes to exempt the submission of labeling content from 21 CFR 11.10(a), (c) through (h), and (k), as well as the corresponding requirements imposed by 21 CFR 11.30. This is mainly because older changes to labeling are no longer relevant.
The agency estimates that complying with the rule will cost industry less than $1 million.
Comments on the rule are being accepted until August 1, 2002. Written comments may be submitted to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments may be sent by visiting www.fda.gov/dockets/ecomments.
Copyright ©2002 Pharmaceutical & Medical Packaging News
