Why Faster Adoption of Electronic Submissions for Promotional Materials Makes Sense

Change is the one constant, but let’s face it nobody likes it. From our experience in life sciences most companies tend to respond to new regulations and guidelines by putting off the inevitable. That’s certainly been the case with the FDA’s eCTD Module 1 guidance for advertising and promotional materials. While reticence to move to eCTD is understandable for a number of reasons, there are so many better reasons to be proactive.

By Karen Stith, Professional Regulatory Writer, CSC

First, though, let’s backtrack a little and outline what the guidelines actually mean. The FDA issued its guidance on electronic submissions of promotional labeling and advertising materials in April 2015. By submitting in XML format, the data is more granular, meaning information is better organized thanks to automation and cataloging.

What’s the Hold Up?

As I said, there are valid reasons why companies have held back. Firstly, there’s uncertainty as to how change will affect them, and in particular companies are worried that it will require more resources to use the Module 1 structure. Then there’s the issue of systems upgrades. Companies are worried that they will run into problems with the software because their various systems will have to be upgraded. Essentially, it’s an understandable fear of the unknown.

There’s also the fact that once you move to eCTD there’s no going back, and that means older submissions will have to be converted if they are to be amended.

But there are many more reasons why progressing toward eCTD for Ad Promo submissions now, rather than later, makes sense.

The granular format gives companies far better manageability of their submissions. It helps you more clearly and succinctly organize the information you have, and lets you manage the content related to your promotional material because it moves you toward a more structured, organized system. In other words, moving to eCTD for your promotional material allows you to work smarter, not harder.

Additionally, sponsors are able to leverage and support the FDA infrastructure. The eCTD Ad Promo submission can be transmitted using the Electronic Submissions Gateway (ESG), allowing automated routing to the correct division and incorporation in the agency’s systems. This is a great deal simpler than sending by courier, then having to load.

So while it’s true that moving to the eCTD will be more time-consuming at the beginning, in the end result it becomes easier to access information and gives you a big picture of what that information means across the business.

Help Along the Way

Moving to eCTD for promotional materials requires a clearly considered transition. If you are working with a partner, you want to make sure they follow a rational and meticulous pathway. Ideally, you should be working with a partner with whom you have a trusted relationship across other parts of the submission process.

At the outset your partner should prepare a plan of action and conduct a gap analysis to assess the current state and what you need to do to get to the electronic submission readiness. Your partner should help with all phases of the planning and execution of your promotional material submissions.

Then there’s the development process, where your vendor partner should map out activities for success. Here it makes sense to leverage regulatory consulting for content review or quality control, as well as to serve on your promotional review committee or assist with medical writing. At the implementation stage, your partner should be making sure your data is updated, you have the metadata they need, and that your staff members have been trained in managing electronic submissions.

Carrot or Stick

At the moment, the FDA is doing their utmost to help companies make the transition. The guidance they issued last year is pretty much a road map to submitting promotional materials electronically. There are some grey areas, with some companies having some issues with the guidance as it relates to website and TV advertising. However, the FDA has made clear in the guidance that any company that runs into issues should call and they will work through those issues with the company.

Ultimately, companies will have to transition to the new Module 1 (v2.3) specifications. Come June 2017 the voluntary implementation will become a mandatory one. It makes sense to make the transition now, while there’s time, and while the FDA has the resources to help, because the Office of Prescription Drug Promotion has a small staff for the NDA promotional submissions, so who knows how available they will be in the lead up to June next year. Our advice would be to act now while the FDA is offering the carrot of assistance, not later when you face the stick of mandatory implementation.

To learn more about eCTD Ad Promo submission, join our Webinar, Ad Promo: Promotional Labeling and Advertising, on January 26, 2016.

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