The Future of Labeling

Jan 01, 2005

Expected SPL Information Flow
In the brief history of electronically filed drug information, there has been one constant—the Portable Document Format (PDF). PDF files have become an essential element of the pharmaceutical world, and no wonder: They're simply created and easily transmitted by e-mail or over the web. They can be read on a variety of platforms using simple, usually free software. They preserve vital formatting and graphic information. And they are durable: Unlike many word-processing documents and graphic presentations, the earliest PDFs, made more than ten years ago, are just as readable today as the day they were created.

But despite those many advantages, the PDF's era is drawing to a close in pharma—at least where regulatory filings are concerned. The change is beginning with labeling information. This past June, FDA began accepting labeling submissions for prescription drugs not just in PDF but in a new format called Structured Product Labeling (SPL).

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By fall 2005, FDA plans to accept labeling submissions for prescription drugs, including annual reports, only in SPL. By the end of 2007 the requirement to submit labeling information in SPL will extend to all FDA-regulated products: OTC medications, devices, diagnostics, veterinary medicines—any product with package information or a package insert.

Simply getting in compliance with SPL is going to be a considerable challenge for many pharma companies. But in fact, the SPL initiative is just the first of a series of initiatives by FDA and the European Agency for the Evaluation of Medical Products (EMEA) designed to take advantage of the possibilities of an increasingly influential computer language: Extensible Markup Language (XML), a higher-powered cousin of the familiar Hypertext Markup Language (HTML), which is used in most conventional websites. These initiatives promise to completely transform the way companies handle many sorts of data.

"SPL is one of the FDA's highest priorities," says James Rinaldi, the agency's chief information officer. The new system will be an important step in the direction of the kind of electronic prescribing information system dictated by the Medicare Modernization Act (MMA), providing easy access to the most current information about prescription drugs based on FDA-approved labeling. SPL also should accelerate FDA review of preliminary labeling and post-approval changes as well as speed communication of any modifications to pharmacists, physicians, and patients.

XML Across the Business
Numerous regulatory submission initiatives will dictate the use of XML, but that is only one of the reasons why industry should pay close attention. In addition, the technology can serve as the linchpin for larger business benefits. Using XML standards, pharmaceutical companies can harness their corporate information assets—the large and constantly growing volume of content that must be managed and archived.

Multiple sources of information and multiple consumers can be managed, including internal knowledge management, partners, contract research organizations, and websites. Companies can share information easily with partners, suppliers, and customers. Interoperability between clinical care and clinical research departments can become a reality.

The arrival of XML on the pharma scene is one of the most important IT advances the industry has experienced, certainly the most important since the introduction of electronic submissions. Companies need to understand both why it's actually in their interest to go through a potentially painful change and how they can implement SPL to put them in a position to take full advantage of the new system's benefits.

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