How Not to Submit Interactive Materials to FDA

In two recent guidances, FDA has requested that sponsors submit materials "in an archivable format that allows FDA to view and interact with the submission in the same way as the end user (e.g., working links)."*

I understand the need to experience digital promotional communications in their native environment to fully appreciate the communication and ensure its compliance.** However, achieving the stated goal of creating an experience for the FDA reviewer in the submission that is the same as the end user is not practical.

The most common format for submitting materials to FDA for the postmarketing submission of promotional materials is via the .PDF document format. Websites, emails, and other digital tactics are converted into PDFs. Typically, this process is achieved by taking screen shots of each webpage or other unit, gathering those screens into a convertible format such as .jpeg files and combining those files into a single .PDF file.

There are various techniques for doing this, and lots of software out there to assist with both the screenshots and the conversions. Adobe has at various points provided software additions that purported to convert an entire website into a single .PDF file at the click of a button. I've worked with most if not all of these solutions, and none of them work. At the end of the day, the only reliable technique to create a .PDF file that looks like the finished piece is to do so manually.

To convert such a file into a piece that functions in the same way as the original thus requires manually building into the .PDF file individual links that move the user around the PDF in the same way as the hyperlinks behave in the website (or email, etc.).

Depending on the complexity of the original piece, that task can be considerable. For example, a 12-page website probably actually has about 25 pages once error states, index pages, and other miscellaneous aspects are included. Assuming 10 hyperlinks per page (which is low), that's more than 120 individual hyperlinks that have to be created (and checked) prior to submission. It's very easy to introduce an error during that manual build.

And the resulting PDF will never be used other than for a 2253 filing. So, there's a lot of effort to create something that no one (outside FDA and the sponsor company) will ever see. A lot of effort with a high likelihood of error for no benefit.

As if this were not reason enough to avoid creating this file, the timing for its creation could not be worse. Digital tactics aren't like print ads. When I submit a print ad to the FDA for a postmarketing submission, the actual ad itself is unlikely to be on newsstands for several days or even weeks. But a digital tactic will often go live immediately after the materials are submitted to the FDA. Every additional minute spent creating the file for the postmarketing submission is a delay in making the materials available.

This also ramps up the pressure on the ad agency or other responsible party to complete the submission as rapidly as possible. That pressure further increases the likelihood of an error being introduced.

To recap, creating fully functional PDFs that recreate the end user experience of a digital tactic is an expensive, time-consuming, error-laden process that delays the deployment of promotional communications and benefits no one other than the FDA reviewers. This is one time I think industry is likely to ignore FDA's request.

* Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, page 6, note 7. See also "The website should allow the FDA reviewer to click on links within the website," in Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs, page 31.

** Indeed, a significant portion of my primer on this topic is devoted to the idea that reviewers have to understand and experience the platform to determine its compliance.

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