Structured Product Labeling Pitfalls and Opportunities

Innodata Isogen Webinar Series Addresses Structured Product Labeling Pitfalls and Opportunities

Drug Makers Scrambling to Comply with FDA Deadline

Hackensack, NJ, USA. March 30, 2005.

The long-term benefits of Structured Product Labeling (SPL) have created many short-term headaches for drug makers as they scramble to comply with the Food and Drug Administration (FDA) deadline of late 2005 for converting drug-related labeling to XML. However, by embracing the SPL mandate as an opportunity to streamline the process for producing label information, some pharmaceutical companies are turning this regulatory requirement into a business advantage.

Innodata Isogen, a leading provider of content supply chain solutions for the information industry, will be conducting two SPL Webinars that will address ways to optimize SPL requirements and avoid common pitfalls on Wednesday, April 6th and April 13th; 12:00 EDT, 9:00AM PDT, 17:00 GMT. For more information or to register, go to the Innodata Isogen Structured Product Labeling web site.

Shepherding huge volumes of content through multiple internal and external hurdles for drugs on the path from the research lab to the marketplace is an ongoing challenge for pharmaceuticals. The question for drug makers is whether they will treat the conversion of product-labeling documents to an open-source digital format as an opportunity or a curse.

Extensible Markup Language (XML), the open-source code the FDA mandated for SPL, has a long track record of success in other industries for supporting single-source publishing systems. XML has the potential to not only speed up FDA review of initial labeling and post-approval labeling changes, but also to help the agency communicate accurate information easily and rapidly to physicians, pharmacists, and patients.

"Faced with increasing requirements to put more information on packages and share it with pharmacists and doctors, more and more drug companies are considering a full XML-based overhaul of their system. However, the road to SPL compliance is also filled with potholes that could derail their efforts," said Dan Dube, director of business analysis for Innodata Isogen. "Organizations that adopt a careful, strategic approach to SPL compliance, one that embraces XML and its potential, will seize a competitive advantage and drive significant improvements throughout their organization."

For a free in-depth report on Structured Product Labeling, go to the SPL resources library.

About Innodata Isogen

Innodata Isogen (www.innodata-isogen.com) provides business and technology services that help organizations create, manage and distribute information more effectively and economically. We are headquartered in Hackensack, New Jersey, just outside of New York City. We have two additional solution centers in North America, seven content production facilities in North America and Asia (the Philippines, India and Sri Lanka) and a technology and tools development center in India.

Contact

Kitchen Public Relations
Anne Steinberg
Tel: +1 212-687-8999
Email: anne@kitchenpr.com

Innodata Isogen, Inc.
Three University Plaza
Hackensack, NJ 07601 USA
Tel: +1 (201) 488-1200
Fax: +1 (201) 488-9099
WWW: http://www.innodata-isogen.com/

Additional Information and References

From the White Paper:

"For many pharmaceutical companies, the task of managing product information is about to become even more complicated. The decision by the Food and Drug Administration (FDA) to mandate Structured Product Labeling will add another layer of complexity to a process that already requires pharmaceutical companies to shepherd huge volumes of content through multiple internal and external checkpoints.

The FDA plans to complete the regulations, standards, and systems needed to switch labeling content from PDF to SPL, an XML output schema, for prescription drugs by Fall 2005 and for all FDA-regulated products by 2007. Converting product-labeling documents to an XML output format like SPL represents a major challenge. But savvy pharmaceutical companies are viewing the SPL requirement as an opportunity to increase productivity and efficiency, not just as another regulatory burden.

Faced with increasing requirements to put more information on packages and share it with pharmacists and doctors, these companies recognize that deploying XML-based content management systems will enable them to automate and streamline the business processes required to create, manage and distribute all labeling-related content.

As companies move to comply with the SPL mandate, they also need to be wary of several potential pitfalls, especially if they decide to deploy new content management systems. These pitfalls typically occur in one of three areas: (1) inefficient business processes; (2) organizational boundaries; (3) technological limitations.

These problems are often compounded when organizations enhance existing legacy systems to support minimal SPL compliance without analyzing their entire content supply chain — the sequence of activities required to create, manage and distribute content.

Organizations that adopt a careful, strategic approach to SPL compliance, one that embraces XML and its potential and takes precautions to avoid these pitfalls will clearly seize a clear competitive advantage and drive significant enterprise-wide improvements...

An SPL document consists of an XML document that contains the text and images in an approved prescription package insert (e.g., the content of labeling) along with additional information for machine processing of label content (e.g.,, header information and data elements). A set of files collectively referred to as a stylesheet converts the PL file to a human-readable format. The stylesheet then displays the information in the XML file in a consistent format for viewing.

Moreover, XML's uniform formatting and the centralizing of content control it affords, enables companies to search all of their product information more efficiently and use it more effectively in all contexts...

SPL is fast approaching as the new standard for the pharmaceutical industry. But companies also have to remember that it's just another step in an ongoing series of FDA initiatives, starting with eCTD, to encourage pharmaceuticals to embrace XML as an industry-wide standard. That's why it is imperative for pharmaceutical companies to develop a strategy that looks beyond the immediate requirement of simply converting their labeling document creation process to XML. By proactively embracing the SPL mandate as an opportunity to examine and streamline the process to generate labeling information, pharmaceutical companies can turn this regulatory requirement into a business advantage.

We've found that organizations that optimize their content supply chain typically find new ways to transform inefficient business processes, flatten organizational boundaries and overcome technological limitations that inhibit the flow of information. Once they improve that flow, the door is often open to an even wider range of benefits — from lower costs to greater operating efficiencies..." [excerpted from the Innodata Isogen White Paper "Turn SPL into a Business Advantage: Three Pitfalls to Avoid on the Road to Successful Compliance"]

References:

Structured Product Labeling (SPL). Local reference document.
"Health Level Seven's ANSI-Approved Structured Product Labeling (SPL). A Model Standard for Present and Future." Announcement 2004-12-31.
HL7 Structured Product Labeling. Release 2. Committee Ballot Version. December 2004. 142 pages. Edited by Gunther Schadow (Regenstrief Institute, Indiana University School of Informatics and IU School of Medicine) and Steven Gitterman (Center for Drug Evaluation and Research, U.S. Food and Drug Administration). HL7 Steward: Regulatory Clinical Research Information Management (RCRIM) Technical Committee.
SPL Implementation Guide for FDA Content of Labeling Submissions. Edited by Steven Gitterman (US FDA). HL7 Informative Document. Sponsored by HL7 Regulated Clinical Research Information Management. Release 1. December, 2004. 100 pages.
Innodata Isogen White Paper
Online Brochure. "Challenge and Opportunity: Meeting SPL Requirements Could Open Door for Improved Savings and Efficiencies." Outlines how Innodata Isogen can help pharmaceutical companies meet the requirements of the FDA's Structured Product Labeling (SPL) mandate and turn this task into an opportunity for cost savings and greater efficiency. Document in PDF
Innodata Isogen SPL webinars
Email contact: spl@innodata-isogen.com

Prepared by Robin Cover for The XML Cover Pages archive.

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However, by embracing the SPL mandate as an opportunity to streamline the process for producing label information, some pharmaceutical companies are turning this regulatory requirement into a business advantage. Innodata Isogen, a leading provider of content supply chain solutions for the information industry, will be conducting two SPL Webinars that will address ways to optimize SPL requirements and avoid common pitfalls on Wednesday, April 6th and April 13th; 12:00 EDT, 9:00AM PDT, 17:00 GMT. For more information or to register, go to the Innodata Isogen Structured Product Labeling web site. Shepherding huge volumes of content through multiple internal and external hurdles for drugs on the path from the research lab to the marketplace is an ongoing challenge for pharmaceuticals. The question for drug makers is whether they will treat the conversion of product-labeling documents to an open-source digital format as an opportunity or a curse. Extensible Markup Language (XML), the open-source code the FDA mandated for SPL, has a long track record of success in other industries for supporting single-source publishing systems. XML has the potential to not only speed up FDA review of initial labeling and post-approval labeling changes, but also to help the agency communicate accurate information easily and rapidly to physicians, pharmacists, and patients. "Faced with increasing requirements to put more information on packages and share it with pharmacists and doctors, more and more drug companies are considering a full XML-based overhaul of their system. However, the road to SPL compliance is also filled with potholes that could derail their efforts," said Dan Dube, director of business analysis for Innodata Isogen. "Organizations that adopt a careful, strategic approach to SPL compliance, one that embraces XML and its potential, will seize a competitive advantage and drive significant improvements throughout their organization." For a free in-depth report on Structured Product Labeling, go to the SPL resources library. About Innodata Isogen Innodata Isogen (www.innodata-isogen.com) provides business and technology services that help organizations create, manage and distribute information more effectively and economically. We are headquartered in Hackensack, New Jersey, just outside of New York City. We have two additional solution centers in North America, seven content production facilities in North America and Asia (the Philippines, India and Sri Lanka) and a technology and tools development center in India. Contact Kitchen Public Relations Anne Steinberg Tel: +1 212-687-8999 Email: anne@kitchenpr.com Innodata Isogen, Inc. Three University Plaza Hackensack, NJ 07601 USA Tel: +1 (201) 488-1200 Fax: +1 (201) 488-9099 WWW: http://www.innodata-isogen.com/ Additional Information and References From the White Paper: "For many pharmaceutical companies, the task of managing product information is about to become even more complicated. The decision by the Food and Drug Administration (FDA) to mandate Structured Product Labeling will add another layer of complexity to a process that already requires pharmaceutical companies to shepherd huge volumes of content through multiple internal and external checkpoints. The FDA plans to complete the regulations, standards, and systems needed to switch labeling content from PDF to SPL, an XML output schema, for prescription drugs by Fall 2005 and for all FDA-regulated products by 2007. Converting product-labeling documents to an XML output format like SPL represents a major challenge. But savvy pharmaceutical companies are viewing the SPL requirement as an opportunity to increase productivity and efficiency, not just as another regulatory burden. Faced with increasing requirements to put more information on packages and share it with pharmacists and doctors, these companies recognize that deploying XML-based content management systems will enable them to automate and streamline the business processes required to create, manage and distribute all labeling-related content. As companies move to comply with the SPL mandate, they also need to be wary of several potential pitfalls, especially if they decide to deploy new content management systems. These pitfalls typically occur in one of three areas: (1) inefficient business processes; (2) organizational boundaries; (3) technological limitations. These problems are often compounded when organizations enhance existing legacy systems to support minimal SPL compliance without analyzing their entire content supply chain — the sequence of activities required to create, manage and distribute content. Organizations that adopt a careful, strategic approach to SPL compliance, one that embraces XML and its potential and takes precautions to avoid these pitfalls will clearly seize a clear competitive advantage and drive significant enterprise-wide improvements... An SPL document consists of an XML document that contains the text and images in an approved prescription package insert (e.g., the content of labeling) along with additional information for machine processing of label content (e.g.,, header information and data elements). A set of files collectively referred to as a stylesheet converts the PL file to a human-readable format. The stylesheet then displays the information in the XML file in a consistent format for viewing. Moreover, XML's uniform formatting and the centralizing of content control it affords, enables companies to search all of their product information more efficiently and use it more effectively in all contexts... SPL is fast approaching as the new standard for the pharmaceutical industry. But companies also have to remember that it's just another step in an ongoing series of FDA initiatives, starting with eCTD, to encourage pharmaceuticals to embrace XML as an industry-wide standard. That's why it is imperative for pharmaceutical companies to develop a strategy that looks beyond the immediate requirement of simply converting their labeling document creation process to XML. By proactively embracing the SPL mandate as an opportunity to examine and streamline the process to generate labeling information, pharmaceutical companies can turn this regulatory requirement into a business advantage. We've found that organizations that optimize their content supply chain typically find new ways to transform inefficient business processes, flatten organizational boundaries and overcome technological limitations that inhibit the flow of information. Once they improve that flow, the door is often open to an even wider range of benefits — from lower costs to greater operating efficiencies..." [excerpted from the Innodata Isogen White Paper "Turn SPL into a Business Advantage: Three Pitfalls to Avoid on the Road to Successful Compliance"] References: Structured Product Labeling (SPL). Local reference document. "Health Level Seven's ANSI-Approved Structured Product Labeling (SPL). A Model Standard for Present and Future." Announcement 2004-12-31. HL7 Structured Product Labeling. Release 2. Committee Ballot Version. December 2004. 142 pages. Edited by Gunther Schadow (Regenstrief Institute, Indiana University School of Informatics and IU School of Medicine) and Steven Gitterman (Center for Drug Evaluation and Research, U.S. Food and Drug Administration). HL7 Steward: Regulatory Clinical Research Information Management (RCRIM) Technical Committee. SPL Implementation Guide for FDA Content of Labeling Submissions. Edited by Steven Gitterman (US FDA). HL7 Informative Document. Sponsored by HL7 Regulated Clinical Research Information Management. Release 1. December, 2004. 100 pages. Innodata Isogen White Paper Online Brochure. "Challenge and Opportunity: Meeting SPL Requirements Could Open Door for Improved Savings and Efficiencies." Outlines how Innodata Isogen can help pharmaceutical companies meet the requirements of the FDA's Structured Product Labeling (SPL) mandate and turn this task into an opportunity for cost savings and greater efficiency. Document in PDF Innodata Isogen SPL webinars Email contact: spl@innodata-isogen.com Prepared by Robin Cover for The XML Cover Pages archive.