Issue 6
Par Pharmaceutical Embraces XML for SPL and Dynamic Publishing
A Strong XML Strategy Built on Quark® XML Author™ Allows Anyone on Par’s Team to Create FDA-compliant SPL Submissions using Microsoft® Word
In 2005, Par Pharmaceutical faced the challenge of complying with a Federal Drug Administration (FDA) ruling that required drug product labels be submitted in XML. By mandating that pharmaceutical companies adopt XML, the FDA’s ruling was disruptive, adding cost and complexity to the process of bringing products to market. In response to the ruling, Par, a developer and manufacturer of generic and proprietary specialty drugs, turned to Quark for an in-house XML authoring solution that allows the team to achieve compliance quickly, easily, and cost-effectively.
Today Par creates and electronically submits compliant, XML-based labeling, drug registration, drug listing, and labeler code registrations to the FDA, and anticipates even more XML requirements from the FDA in the future. With Quark XML Author, Par is also able to plan for and achieve savings by using XML to automate downstream processes, such as producing labeling and packaging, which are currently both labor-intensive and error-prone.
Structured Product Labeling (SPL) Rulings
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In early 2004, the FDA passed the Structured Product Labeling (SPL) ruling requiring that prescription drug manufacturers submit specific and detailed information about their products as a part of the drug approval process. The ruling mandates that the SPL content be submitted in XML, a standard for structuring documents.
At the time, the FDA accepted both electronic and hardcopy submissions in Microsoft Word and PDF. As part of the evolution of SPL rulings, the FDA approved the Physicians Labeling Rule (PLR), which requires that content for product labels must not only be submitted in XML, but also in a specific format and layout. And most recently, the FDA issued SPL R4, a revision to SPL that mandates that starting June 1, 2009, all product label content must be submitted by pharmaceutical companies electronically in XML.
Although these efforts by the FDA make it much easier for doctors and consumers to gain access to accurate drug information quickly, they have had a significant impact on pharmaceutical companies. Now drug manufacturers are forced to understand a complicated authoring language – XML – as well as submit product details in a very specific format.
Becoming Compliant: Outsourcing versus In-House XML
There are two common options for meeting the SPL mandate: convert Microsoft Word and PDF documents to XML in-house, or outsource the conversion.
Very few people in charge of submitting product details are familiar with XML in general or the specific XML coding of SPL. Outsourcing takes the burden of learning XML off the product and marketing teams. On the other hand, the team loses control of their information, conversion services are expensive, and there is a high potential for client conflict at the vendor.
Par considered outsourcing conversion of their SPL labels, but ultimately opted against it. Michele Cobham, submissions manager for regulatory affairs at Par, leads the effort to ensure Par is SPL compliant. She said, “At the time of the original SPL initiative there were significant issues around outsourcing XML conversion. Cost, first-to-file labeling, and possible conflicts with other clients at the conversion houses were enough to warrant the creation of labels to be kept within Par.”
Rejecting the option to outsource, Cobham and her team tested several solutions for converting its initial labels into XML, but many of the tools proved to be too complicated. Along the way, however, she discovered Quark XML Author, a key component of Quark Dynamic Publishing Solution that allows users to create XML content directly in Microsoft Word. Par tested – and soon adopted – Quark XML Author with Quark’s SPL Accelerator to bring the creation of SPL-compliant labels in-house.
Quark XML Author
Quark XML Author is an add-in to Microsoft Word that lets anyone create XML documents — without seeing tags, being constrained to boxes, or being aware of the technical complexities associated with XML. The Quark SPL Accelerator, which Quark developed specifically to address FDA requirements for the SPL format, is an out-of-the-box solution for producing SPL submissions using Quark XML Author and Microsoft Word.
The fact that the authoring environment in Quark XML Author is Microsoft Word was very important to Cobham’s decision to go with Quark. “Microsoft Word is the standard word processer within Par. Having an XML authoring environment in a familiar application was crucial because we are not only used to, but adept at working with Microsoft Word. It was a simple approach that we could embrace quickly.”
Because Quark XML Author with Quark SPL Accelerator requires minimal training, Cobham and her team were able to implement Quark XML Author and begin submitting compliant, XML-based product labels to the FDA within three days. The quick turnaround time saved the company time in bringing drugs to market and improved revenue potential while allowing Par to maintain control over their intellectual property.
To read the entire case study with Par Pharmaceuticals, please visit: http://dynamicpublishing.quark.com/xml_author/ParCaseStudy.html
