Genetic Engineering News Reports on FDA's Electronic Product Labeling Initiative

Business Wire, Nov 18, 2004

LARCHMONT, N.Y. -- Implementation of FDA's draft guidance for electronic product labeling will dramatically streamline agency submissions and internal labeling documentation in the long term, according to Genetic Engineering News (GEN; www.genengnews.com). The short-term outlook, however, shows signs of confusion, reports the November 15 issue of GEN.

For example, the standard to determine how electronic labeling using eXtensible Markup Language (XML) in the new structured product labeling (SPL) standard will be applied to labeling isn't yet finalized. Also, technology vendors are in the early stages of product development to meet and help finalize that standard. Moreover, pharmaceutical companies tend not to have begun planning a migration path from the current labeling content format to the new XML-based format.

"With implementation less than one year away, uncertainty seems certain," notes John Sterling, Editor-in-Chief of GEN.

The FDA draft guidance, "Providing Regulatory Submissions in Electronic Format --Content of Labeling," was released February 5, 2004. It created a new role for electronic labeling information, allowing it to support electronic prescribing and patient records. Migrating to electronic labeling using XML will make content management more modular by creating reusable information components, and can cause a huge change in the way companies manage labeling information (which includes labels, package inserts, marketing communications, regulatory submissions, etc.).

A number of companies see opportunities in the electronic labeling initiative. These include Intrasphere Technologies (New York City) and its spinoff firm, Concise Content, Liquent (Fort Washington, PA), and Glemser Technologies (Bethlehem, PA).

Genetic Engineering News is published 21 times a year by Mary Ann Liebert, Inc. For a copy of the November 15, please call 914-834-3100, ext. 623, or email: ebicovny@liebertpub.com