Medical Device Link.

Originally Published PMPN February 2004

Regulatory Focus

Each year FDA spends valuable review time conducting word-for-word comparisons during its review of proposed labeling changes. These include proposed labeling changes for ap-proved new drug applications (NDAs), biological license applications (BLAs), and abbreviated new drug applications (ANDAs).

The agency admits that this process is “slow and subject to error.” To speed up review and reduce the likelihood of mistakes, the agency has ruled that all labeling content of package inserts and professional labeling, including all text, tables, and figures, be submitted electronically to the agency.

The final rule, “Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format,” is effective June 8, 2004. A draft of the rule was published May 3, 2002. After receiving and reviewing 13 comments, the agency decided to publish the draft with no revisions.

FDA requires that electronic submissions be in portable document format (pdf). Other media previously accepted under sections 314.50 (l)(1) and 314.94 (d)(1) of the Code of Federal Regulations, like microfiche, microform, optical disk, and magnetic tape, will no longer be accepted. FDA may consider other, newer file formats should they become widely available. 

Of the written comments submitted to FDA, one person expressed concern that the new rule would facilitate “the elimination of printed patient inserts (PPIs).” FDA responded by stating that while the rule required such labeling to be submitted electronically, it does not “alter the current regulatory treatment of PPIs.”

The agency, however, does plan to use such electronic labeling to help the National Library of Medicine with an initiative to promote patient safety through accessible medication information (the DailyMed Initiative). FDA will “provide the DailyMed system with labeling in a comprehensive, reliable, and structured format.” DailyMed can then distribute this information to consumers, health professionals, and others.

In response to another comment, the agency clarified that the rule does not apply to carton and container labels, labels submitted with advertising material, labeling that might be submitted with periodic adverse drug experiences, and labeling submitted with annual reports. 
This final rule exempts the electronic submission of labeling content from the requirements of 21 CFR Part 11.10(a), (c) through (h), and (k), and the corresponding requirements of sect. 11.30.

FDA has come to this decision, it writes, “because we believe Part 11 requirements are not critical to ensure the quality of the content of labeling submitted under this rule, and we want to ensure that industry resources are not being spent on unnecessary controls. For example, validation for the system used to generate the labeling record is not necessary because the applicant’s verification that the information in the labeling record is accurate serves the same objective.”

For more information, please visit www.fda.gov/OHRMS/DOCKETS/98fr/03-30641.htm.  

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