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Prastera: A Drug Listing Submission Case Study


Mark Gross offers a case study in using structured product labeling (SPL) to reduce time to market.

For healthcare providers and their patients, time to approval and to market is everything, and every day saved has value - both to companies marketing these new drugs, and to the patients desperately waiting for them. One of the last hurdles in making new drug therapies available is ensuring that an accurate listing, compliant with Center for Drug Evaluation and Research (CDER) requirements, is published.

Pharmaceutical companies can spend months in FDA review of listings process, and data errors at this stage can cost further delays of many weeks. The risks associated with delays of a drug listing underscore the criticality of ensuring that Structured Product Labeling (SPL) files are accurate before submission to the CDER. A fail-safe process, and collaborating as a team to uncover potential problems before FDA review, greatly reduces the time to get drugs to market, and into the hands of providers and their patients.

In this case study, we look at Prastera, a new lupus treatment. Current leading treatments on the market for the auto-immune disorder, affecting nearly 1.5 million Americans, are either largely ineffective or have significant side effects that damage the kidneys. Health Science Funding LLC’s (HSF) Prastera, which has no serious side effects and can significantly reduce the risk of breast cancer in patients, shows remarkable promise. The treatment, in the form of a kit, combines Prastera with Ibuprofen.

Overcoming 9 Months of High Anxiety

When the time came to submit the drug listing, Mark Pohl, HSF’s president, worked with a well-known company to prepare the initial XML files for submission to the CDER.

Unfortunately, the project soon ran into the kind of delays that every company fears. After nine months, the company had only a partial listing for the kit in the wrong marketing category, which prevented the kit from being prescribed and distributed by healthcare providers. In addition, the technical errors in the SPL files meant that scientifically accurate information could not be made available to clinical decision support systems, one of the underlying reasons that the FDA and the SPL Working group undertook development of the SPL standard for labeling.

“Using a vendor that could simply create the necessary SPL files proved to be far from ideal,” said Pohl. “Lack of communication with us, and just as important, lack of understanding of the FDA submission and review process, created problems that ultimately impacted production, marketing, and distribution; every facet of the successful launch of Prastera was put at risk.”

The listing submission must be done using the FDA’s proprietary, and somewhat challenging to use, online XML tool. The review process includes automatic validation checks that the submitted files must pass or face being flagged for manual review. During the course of the review, the filing company may submit exception justifications, as well as corrected files that may introduce new errors into the SPL files, risking a lengthy cycle of repeated reviews and resubmissions. Not having an expert in the SPL schema or the FDA tool on staff, and risking further delay by continuing with the vendor, Pohl had needed to find someone who understood both the technology, and the processes around online submission.

Changing Vendors to Save Time, Money, and Lives

HSF was able to salvage the situation by swapping out vendors to one that was able to create and submit accurate, properly structured SPL files to the FDA rapidly enabling reviewers to go through the automated validation phase more quickly. Key was the understanding not just how the validation checks worked and the nature of the data they wanted to submit, but also the ability to identify where exception justifications might be needed. This was key to preparing for the review process in advance of the submission.

SF also needed a way to use readily available tools to create the SPL files and review and proof them quickly, without struggling with the FDA’s proprietary tool. The new vendor designed a more familiar Excel worksheet to make it easier to collect all the needed SPL data, rather than working directly with the FDA’s tool, which eliminated both the struggles with the FDA system and the need for XML expertise.

nce the worksheet was completed, data can be transferred to XML-SPL conforming to the FDA’s schema while providing recommendations on possible problems. For HSF, a vendor that could anticipate problems and help formulate a strategy for dealing with them made a tremendous difference, saving precious time in the subsequent review.

Attention to details, understanding of processes and a proactive approach to preparation and submission paid off. Where before, after nine long months, HSF had only a partial listing, switching to a knowledgeable, experienced vendor resulted in having the submission files in hand within three weeks. Addressing exceptions took an additional two weeks. The complete kit was listed on CDER after a total of five weeks. Five weeks for a complete, accurate listing, versus 36 weeks for an incomplete listing in the wrong category!


After months or years of research, development and testing new drug therapies, listing companies want to clear the final regulatory hurdles and get to market. The expertise required is far different from that for developing those products. The right vendor will:

•    Understand SPL, and specifically the FDA schema requirements for product labeling
•    Spend time analyzing the situation up front so that the real problem can be quickly addressed.
•    Do all of the heavy lifting to set up and convert the data, leaving the pharmaceutical company more time to do quality checks on the files to be submitted.

Mark Gross is CEO and founder of Data Conversion Laboratory (DCL) and a recognized authority on XML implementation and document conversion. DCL (www.dclab.com)

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