Module 1 Changes Bring Marketing and Regulatory Closer, But Disparities Need to be Managed

Last month some of my colleagues and I attended the DIA’s annual eRegulatory and Intelligence Annual Conference. It was an opportunity to hear about regulatory developments and talk to thought leaders about the changing regulatory environment.

On the afternoon of day 1, senior FDA staff members offered an update. In particular, I’d like to focus on the presentation from Roberta Szydlo, who is senior regulatory review officer for the Center for Drug Evaluation and Research (CDER). Roberta’s presentation focused on promotional materials and the new version of the U.S. eCTD Module 1, which the FDA will start accepting very soon, on June 15, 2015. I’d like to talk about are some of the disparities with this new version.

One of the major changes to Module 1 is the ability to have promotional materials associated with your application. First, let me say that the change makes sense both from a regulatory and marketing perspective because you’re supposed to submit your marketing materials before they are released. In addition, the change also makes regulatory more visible to groups they previously may not have had much experience with – marketing, legal, and finance.

But from a management perspective, it’s not that simple because there is a process that has to be mapped out and given due consideration, and it’s not clear to me that those aspects have been clearly thought through.

Messaging vs. Compliance

What do I mean by that? Typically in a submission, regulatory is working with CMC, pre-clinical and clinical on authoring the dossier. But the ability to include your promotional materials in your Module 1 means regulatory will be working with a new set of stakeholders – marketing, legal, and in some cases finance. Marketing, meanwhile, will not be accustomed to the rigors of a dossier, so for example, they’re not going to look at the submission and say “I need to make sure my metadata is tagged in this way.” What they’re focused on is that the promotional materials have the message they want to deliver to medical professionals or other end users, such as patients. So you have the messaging and image marketing wants to deliver in the promotional materials, on one level, vs. the regulatory compliance side. This second part is critical or the promotional material might be pulled from the market, but it’s not clear that marketing knows what it takes to complete the regulatory requirements or indeed vice versa.

With the new structure in Module 1, specifically 1.15, there are criteria that each of the categories need to meet. The issue is managing these criteria, as well as the drug listing or the most current label that is supposed to support what you’re stating in the promotional materials, and the issue is that life cycle required within eCTD hasn’t been fully mapped out yet. There are two scenarios in particular where this could be a real challenge for companies.

Finding the Gaps

The first potential pitfall is when there are changes to promotional materials. Within eCTD you’re only supposed to submit a document once and then you create copy links to that document. But the Office of Prescription Drug Promotion (ODPD) is asking that companies submit the drug label each time, so you have the same copy of the same file for each submission, meaning it’s all within one package rather than referencing back to what had been submitted previously. This is a divergence that needs to be resolved.

The second scenario involves grouped submissions, which the new Module 1 also allows for. Here the question is, if you’re changing the promotional materials across a number of applications and leveraging that grouped submission, and have to do a replace function or delete function, how will that be possible if the application is within a primary dossier?

There will be many benefits to companies with the new Module 1, but the bumps need to be ironed out or at the very least clarified before too many problems arise.


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