Applying the FDA's New Electronic Product Labeling
The XML Migration
GAIL DUTTON
Genetic Engineering News, v.24, n.20, 15nov04
Implementation of the draft FDA guidance for electronic product labeling will dramatically streamline agency submissions and internal labeling documentation in the long-term. The short-term outlook, however, augurs confusion.
The reasons are threefold. First, 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.
Although the agency currently accepts submissions in PDF, XML, and (as of September 24, 2004) SPL, implementation has been postponed from July 2005 to sometime that autumn, according to an FDA memo from Margo Burnette, director of the office of Information Technology, Center for Drug Evaluation and Research. The FDA currently is developing an automated system to process, review, and archive SPL submissions.
Second, technology vendors are in the early stages of product development to meet and help finalize that standard. Third, 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, a degree of chaos seems inevitable.
The FDA draft guidance, "Providing Regulatory Submissions in Electronic Format — Content of Labeling," was released February 5, 2004.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 electronic patient records.
That necessitated changing from the portable document format (PDF) currently used by FDA to the Clinical Document Architecture, which exchanges data using XML.
SPL and PIM
To define the rules by which the XML-tagged language would be applied to labeling content, the SPL standard has been developed, explains Joe Jenkins, director of marketing, life sciences, Arbortext (www.arbortext.com). It is designed specifically for pharmaceutical and biotechnology product labeling.
To further complicate (or streamline) the regulatory environment the European Agency for the Evaluation of Medicinal Products (EMEA) is introducing the product information management (PIM) standard in about the similar time frame, with similar requirements, aimed at creating consistent labeling across the region.
According to Monika Bernstetter, press office, EMEA, "The PIM project is being taken forward on an iterative basis. Specifications sufficient to enable the letting of a contract to develop the system for use by the national competent authorities and the EMEA are complete except for two elements of detail." The final data exchange standard (DES) was published in September, and is now in a comment period.
That PIM standard also relies upon XML and, like the FDA's standard, isn't quite finalized. Nonetheless, savvy vendors and multinational companies expect to incorporate both into their business processes.
Benefits of XML
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.).
Basically, document management becomes information management, as companies manage bits of information, such as indications, contraindications, and dosage, rather than separate documents that use that information.
The key feature of XML is that its content is separate from its formatting. Consequently, manufacturers can create one unformatted, XML master document that includes all of the labeling information for a given product. From that master document, all of the other labeling documents for that product can be generated and formatted automatically. The result is that data is created once, but used many times throughout the organization.
Kris Spahr, of the SPL working group, listed benefits of using XML to create labeling documents at the FDA's CDER meeting last June, which include eliminating redundant data collection used for other submissions, increasing efficiency in internal label management, allowing the potential for more reusable product content across the enterprise, and defining a consistent, predictable means of exchanging labeling content.
To that list, the FDA adds the ability to easily search all of its documents for keywords, something that couldn't easily occur with PDF files.
Challenges
The biggest challenges in migrating to XML are organizational changes related to workflow, according to Tom Moore, practice manager, Intrasphere Technologies (www.intrasphere.com).
"XML is a disruptive technology," notes colleague Jake Nadler, vp, business affairs. "Historically, there hasn't been a smooth transition when structured authoring has been implemented." Moore interjects, "People are used to editing a monolithic document. Now paragraphs, sentences, or words are pulled together," and that makes some people uncomfortable.
"There's always resistance to change," Jenkins comments, "but once our customers have recognized the tangible benefits of SML throughout their content creating and publishing processes, there's no desire to go back to unstructured content."
The SPL Working Group (composed of representatives members from the FDA, industry, and vendors), is conducting a pilot project in preparation for implementation. Intrasphere Technologies developed an XML labeling system for that pilot.
Results from the pilot show that the two-day training course "very critical," Moore says. "XML is a big technological change that people aren't ready for. They need time to demystify the technology."
Adding to the confusion is the fact that the SPL standard isn't finalized yet. Decisions still must be made regarding the handling of legacy labels, description of elements, how the standard will affect the tools used for agency submissions, and the affects on business lifecycle and on submissions themselves.
For example, adds Jim Nichols, vp, product strategy and marketing, Liquent (www.liquent.com), "if an update changes a few words of a paragraph, companies and the FDA need a way to make accurate references to those words or to that paragraph."
The technical details will be worked out in time, but companies need to begin planning to migrate to XML now.
Migration Pathways
There are three broad migration pathways, Jenkins says. "Service bureaus can convert the content," most of which is MS Word or Quark Express, he says. For a firm with only one or two products, this maybe a viable option. For multiproduct firms, it could be time-consuming, cumbersome, and expensive, particularly as submissions are tweaked throughout their lifecycles.
A second option is to deploy tools within the company to convert or author content into XML format. Many vendors are building such tools now. A third option is to redesign the information management architecture to implement XML functionality across the enterprise, in preparation for additional XML-based regulatory requirements (like electronic health records, stability reports, and clinical trial protocols).
XML is becoming the standard for data exchange between different database and business applications, notes Dan Fregeau, executive vp, Document Sciences (www.docscience.com), an XML-based content processing company. As a result, there are many different "dialects;" SPL being one of them. Companies will need to migrate to the applications that are sufficiently sophisticated to incorporate SPL.
Appilcations
Glemser Technologies' (glemser. com) xmLabeling® solution "is an evolution of labeling content management solutions we have deployed for several clients," according to Ken Lownie, vp, sales and marketing.
"Our approach is to address the fundamental content management challenges involved in labeling while supporting both monolithic and `componentized' XML formats, and the SPL and PIM standards. We think it's better (for a drug developer) to rebuild the data management architecture now," Lownie says, to reap greater efficiency, and ultimately, decrease time to market. "Label approvals are on the critical path," he notes.
Glemser's xmLabeling product creates output using the emerging SPL standard and incorporates Arbortext's XML editing capabilities and Documentum's document management system.
In this application, "labeling components are maintained in XML and then assembled and rerendered in SPL or PIM on the fly. The result is that users can manage a single version of each labeling component rather than dealing with multiple versions of labels for different packaging, alternative dosages, and in multiple agency-required formats," Lownie says.
A beta version of Arbortext's Product Information application will be released fourth quarter of this year, with the first release planned for the first quarter of 2005, Jenkins says. The application provides comprehensive information management, allowing companies to author in XML and publish in SPL.
The same Arbortext products will provide the IT infrastructure for other XML standards (like those being discussed for clinical trial protocols and stability reports), as well as HTML and other data exchange standards. PIM support is also planned for a future product release.
"
Liquent is expanding the InSight family of products for SPL creation and maintenance," notes Nichols. The maintenance aspect is important, he says, because it's not enough to create the documents. They will be changed over time and software must be able to accommodate those changes.The family will incorporate several InSight applications, such as the InSight Manager for Registrations, which captures product detail information before it goes into SPL, Nichols says. Products are expected to be released for the second quarter of 2005.
Concise Content, a spin-off of Intrasphere Technologies, is developing the XML Global Labeling Solution as a "middle-tier" approach to migration. Developed with a pharmaceutical company, it offers a standards-based approach to authoring documents.
The key, Moore says, is that it's a truly global solution. It supports standards in the U.S., EU, Japan, China, Brazil, South Africa, and other nations, so multinational companies can manage information in a common fashion.
Advice
The implementation date is now Fall 2005, and the SPL standard is in place as an ANSI standard, but the FDA's SPL guidelines are still in draft form. "Companies are just now requesting information," Lownie says. "It seems as though some firms are abetting there will be another extension of the implementation deadline:'
What is certain, however, is that companies must adapt their information management processes to comply with this new guidance. "Interview solution providers now;" Nichols recommends.
Before beginning the transition, Jenkins advises that companies "first work on identifying and refining labeling content creation and publishing processes" to understand what happens now and how SPL can provide organizational benefits through creation of such labeling-related documentation as product websites, promotional materials, and package artwork. Don't automate a bad process,' he admonishes.
Then, Jenkins advises, "understand that XML is standards-based. Third-party tools can be integrated, which may increase information sharing across the enterprise?' That, in turn, may create additional synergies and efficiencies.
Finally, "spend two to three days, up front, training. You'll save time by not going through an extended learning process," Jenkins says.
The FDA is becoming increasingly interested in introducing structured authoring into FDA submissions. Electronic labeling is among the first, but others will certainly follow. Expecting this and planning for it now, in time for this first migration, can streamline future migrations for other submissions elements.
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