The long-term benefits of XML-based Structured Product Labeling (SPL) are creating many short-term headaches for drug makers as they scramble to comply with the Food and Drug Administration (FDA) deadline for electronically processing all drug-related labelingcontent.

Managing product information - 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. Although accurate and consistent product information is as vital as the drug itself, today's cumbersome systems for handling such information make it increasingly difficult to serve all channels consistently.

The FDA plans to complete the regulations, standards, and systems needed to switch labeling content from PDF to SPL, an XML schema, for prescription drugs by late 2005, and for all drugs by 2006. Without question, converting product-labeling documents to SPL is a major challenge. The question for drug makers is whether to treat the conversion of product-labeling documents to an Open Source digital format as a headache or an opportunity.

Faced with increasing requirements to put more information on packages and share it with pharmacists and doctors, drug companies are confronted with two distinct choices: 1) try to apply a band-aid by "enhancing" existing legacy systems to support minimal SPL compliance without analyzing the entire content supply chain, or 2) re-engineer business processes and the technology infrastructure by implementing XML-based content management systems to leverage the full benefits of content reuse and single-source publishing.

Pharmaceuticals As Publishers
Few external documents are as critical to a pharmaceutical company as product labeling. Closely regulated by the FDA and other international regulatory agencies, these documents deliver critical information to doctors, pharmacists, and patients about drug interactions as well as instructions on how to take the medicine. They also go far beyond product inserts; labeling documents often contain thousands of printed pages detailing the drug's chemical composition, the medical conditions it addresses, and the potential side effects or contra-indications.

Managing product information has become far more complex both inside pharmaceutical companies and outside in the healthcare system they serve. In today's global healthcare companies, numerous departments across the organization create and use product information for distinctly different purposes. New research and new uses for drugs often bring changes in labeling. For many companies, far-flung global operations make it difficult to coordinate all of the activities that affect labeling, despite ubiquitous information technology.

The complexity only increases when product information finds its way to the FDA, onto labels and Web sites, and into promotional literature. Many constituencies - physicians, pharmacists, researchers, regulators, and patients - access the information through a variety of channels and depend on it to guide them in making critical decisions. As time has passed, the systems for gathering product label information and disseminating it to pharmacists, doctors, and the public have grown more complex and more susceptible to error.

All of these factors greatly multiply the potential for errors, inconsistencies, and liability. For example, a drug produced in multiple formulations requires separate packaging and labeling information for each formulation. Should labeling for one formulation mistakenly turn up in a different one, the pharmaceutical company could face a variety of adverse consequences, including an FDA recall. Similarly, if a company updates a labeling change in the package insert but not on its Web site, a physician or a patient could inadvertently make important decisions on the basis of faulty or incomplete information.

Just like a publishing company, pharmaceuticals have to create, manage, publish, and distribute content. The major publishers have already discovered what SPL is forcing big pharmaceuticals to figure out - that they can drastically reduce the cost of their content supply chain by implementing XML-based content management systems.

Why XML?
In 1999, the FDA began allowing the electronic submission of product labeling information in Portable Document Format (PDF) files that enabled the agency to process, review, and archive labeling content electronically. In response to the recommendations of the Institute of Medicine and the National Committee on Vital and Health Statistics as well as mandates in the Medicare Modernization Act of 2003, the FDA created a new role for electronic labeling information - to support health information management technologies such as electronic prescribing and the electronic health record (EHR).

When the FDA determined that using PDF documents would no longer adequately support those initiatives, it published the last electronic labeling rule in late 2003 that required the submission of the content of labeling in electronic format for marketing applications for drugs and biologics. Working with interested parties in Health Level Seven (HL7), a standards development organization, the agency adopted a proposed standard called Structured Product Labeling for describing the content of prescription drug labeling in an XML document.

An SPL document consists of an XML document that contains the text and images in an approved prescription package insert (e.g., the labeling content), 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 SPL XML file to a human-readable format. The stylesheet displays the information in the XML file in a consistent format for viewing.

SPL offers numerous advantages over PDF, enabling, for example:

• The automated exchange of information among disparate IT platforms, applications, and interfaces
• A more efficient exchange of changes to labeling content
• The comparison of text and specific data elements
• The exchange of information needed for other submissions, such as drug listing, eliminating redundant data collection, and improving efficiency
• Reuse of common components of content between labels and other relevant documents (e.g., promotional literature, packaging, Web site content, package inserts for different formulations, and submissions to regulatory bodies outside the U.S.)
• The rendering of labeling content into multiple output formats (e.g., PDF and HTML) from the same XML source file