The Latest on FDA Tobacco Submissions

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The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) and the tobacco industry are in the exploratory stages of developing a standard for electronic submissions. Statistics on tobacco product applications evaluated to date combined with the scant regulatory experience of the industry indicate that progress toward a standardized submission and review process will be deliberate.

On July 18, the FDA convened a public workshop to discuss a range of topics related to submitting in electronic format. Representatives of various FDA departments, industry stakeholders and legal professionals were in attendance. A complete webcast of the event was archived by the FDA and is available here.

The first step toward realizing an electronic standard is to write legislation that sets forth rules for submission. Rule-making does not happen overnight, and the overall timeline is predicated upon industry involvement, public commentary, guidance drafts, political maneuvering, and Agency priorities. Nonetheless, when finalized, expect the standards to be similar to those established for drug companies with some exceptions.

Unlike drug manufacturers that have been heavily regulated for more than a century, tobacco companies must develop systems for regulatory reporting. Mastering the rudimentary aspects of electronic submissions such as document formatting, interoperability between industry and Agency, and data collection, are critical to success. Until then, the FDA should consider a flexible approach, i.e. accepting single PDFs as well as fully-tagged XML documents.

This June the FDA’s CTP acted on tobacco product applications for the first time since the Agency received the authority to do so. Marketing of two new tobacco products was authorized, while four others were denied. While this was a significant event, there is an Agency backlog of at least 3,500 applications. Mitch Zeller, who was named CTP director in March, considers the backlog a high priority and has promised quicker Agency reviews.

“FDA has been working diligently to review all pending substantial equivalence submissions,” he wrote on the FDA Voice Blog in June. “We know it’s taken time, but expect the process will move more quickly in the future as everyone involved gains more experience.”

The law authorizing the FDA to “regulate the manufacture, distribution, and marketing of tobacco products to protect public health,” is commonly referred to as the Tobacco Control Act. Products approved under the guidelines established by this legislation are not deemed safe by the FDA, but rather, substantially equivalent (SE). SE products are acceptable when they do not increase existing levels of harm.

Public comments on the electronic submission of tobacco product applications are being accepted to the docket in electronic or written form until August 19, 2013.

Author: Jason Rock

Jason Rock is a pioneer in the field of electronic submissions. Mr. Rock has an extensive background working with global life sciences companies and regulatory agencies to promote eCTD adoption through the development of advanced applications. The commercial software Mr. Rock originally developed, and continues to improve, in his role as Chief Technical Officer for GlobalSubmit, is used exclusively by the U.S. Food & Drug Administration to review and validate all eCTD submissions the FDA receives.

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