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Implementing the Final FDA Guidance on Electronic Submissions of Promotional Materials

Get ready for the FDA’s June 2021 deadline

On June 21, 2019, the FDA finalized its guidance on the electronic submission of promotional materials, ending four years of industry experimentation with this process.

By June of 2021, organizations must submit promotional materials electronically (via eCTD) for the following two types of submissions:

  1. Postmarketing submissions of promotional materials using form FDA 2253
  2. Presubmission of promotional materials for accelerated approval products

The final guidance outlines requirements that impact everything from how to display promotional materials electronically to titling them in the submission package. Due to its complexity, the document will impact multiple stakeholders in the advertising and promotion process and may require organizations to add new roles.

To prepare for the June 2021 deadline, Veeva recommends companies focus on five key areas:

  1. Defining standards for material submission
  2. Identifying roles and responsibilities
  3. Optimizing the submissions processes
  4. Transitioning applications
  5. Evaluating and analyzing progress

1. Defining standards for material submission

The guidance lays out specific requirements for how to present promotional content in the transferred submission package. To help ad/promo teams get started, the FDA provides seven examples of how to lay out materials.

As a first step, ad/promo needs to align with marketing to develop company-wide standards for each material. Typically, organizations come up with internal guidance documents for common content types such as websites, emails, banner ads, printed materials, etc. Only when teams agree on the final standards (and communicate updates to agency partners) can they develop their eCTD submission strategy.

This simple step provides the foundation for electronic submissions and will limit the need for rework in the late stages of the ad/promo review process.

2. Identifying roles and responsibilities

At first look, the FDA’s guidance may appear complicated for teams who have never submitted promotional materials through the gateway. However, the electronic process isn’t much different from a paper submission – it simply requires teams to reevaluate and sometimes shift certain responsibilities within the organization.

The best approach to understanding how roles might change is to separate the creation and approval of the package from its submission to the FDA.

Today, ad/promo teams typically do both; they gather documents, print them out or burn them to a CD, and send to the FDA via a delivery service.

Now that teams must submit promotional materials electronically, ad/promo will need to work more closely with regulatory operations to build submissions and deliver them via the gateway. It’s important that these two groups determine who’s responsible for creating and approving the package, and who’s responsible for submitting the package. This decision is usually driven by organizational competencies, SOPs, and software.

Once they define responsibilities, teams should document the following:

  • The handoff process
  • Service-level agreements (time to complete tasks)
  • Communication plan
  • Metrics to track submissions

Establishing these requirements before assembling the first submission is absolutely critical to a smooth transition – once an applicant begins to submit promotional materials via the gateway, they cannot revert to the paper or CD process.

3. Optimizing the submissions process

As organizations finalize key roles and responsibilities, they should start to evaluate how they can optimize and automate processes in their current creation and submission systems. This may include adjusting workflow configurations or adding new roles.

Evaluating and implementing changes takes dedicated time and effort. Organizations should carry out these updates by Q1 of 2020 to ensure that they are ready to compliantly meet the submission requirement by June of 2021.

4. Transitioning applications

Updating the submission process from paper to electronic format is typically done on an application-by-application basis (individual NDA, BLA, ANDA). This allows teams to align any technical transitions in the submission tool to standard milestones, like annual reports or label updates.

Organizations should start with products that are less promotionally active so that teams have time to understand processes and handoffs while ensuring compliance. Ideally, similar products will be converted at the same time. If an organization has multiple products in multiple therapeutic areas, for example, it should focus on converting one therapeutic area at a time.

Companies also need to define and communicate the plan for transitioning each product onto the new system. It’s best to communicate timing to all impacted teams at least 30 days in advance. This ensures that everyone understands expectations and is working towards the same goal.

5. Evaluating and analyzing progress

As with any change management program, it is important to communicate clearly so that teams stay informed of a project’s status. The eCTD transition process is no different.

Successfully migrating to an electronic submissions format requires keeping everyone up to speed with the company’s progress; consider sharing a monthly report of important metrics, like which products have converted, how many submissions have been done and which are still pending. Giving people forward visibility ensures teams remain aligned to overall objectives and timeframes.

Get started today

The FDA’s guidance on promotional material submissions is opening up an exciting time for ad/promo review teams. Organizations should take the opportunity to not just meet the requirements but also streamline their processes to optimize their internal and external communication.

June 2021 is closer than it may seem – it’s important to get started on the development and execution of an implementation strategy to comply with the new guidance right away. Veeva recommends evaluating and fully converting at least one product to the eCTD submission method by June 2020.

If you have questions about where to begin or want to learn more about the guidance, contact Bill Robinson. Bill will also be available for 1:1 meetings at the upcoming Promotional Review Committee: Compliance & Best Practices Conference in Morristown, NJ.


Visit FDA.gov to access the final guidance, “Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs.”