DXC offers a five-step process that clients can choose from, based on their level of compliance in meeting the FDA’s submission requirement.
Getting started with electronic submissions for promotional materials
In 2015 the U.S. Food and Drug Administration (FDA) began accepting electronic submissions for drug promotional labeling and advertising (AdPromo). But in 2017 — a date not that far off — submitting both drug and biologic AdPromo submissions digitally will become not just optional, but mandatory.
Yet many sponsors have delayed the move to electronic Common Technical Document (eCTD) submissions. While the reasons for postponing are understandable, the reasons for being proactive are even more compelling. To help drug sponsors get started, DXC now offers next-generation AdPromo services and solutions.
The FDA’s eCTD Module 1 v2.3 guidance applies to all promotional materials and pieces, regardless of format, manner or medium. That includes TV ads, brochures, booklets, websites, print ads, radio ads, exhibits and more. To leverage the eCTD format, these advertising and promotional materials will need to be submitted using the XML format, which promises to dramatically improve information sharing, processing, reviewing speeds and organization.
But if eCTD is so important, powerful and helpful, why are many sponsors dragging their heels on compliance? There are several reasons. Some are concerned about the need for extra resources and management, precisely at a time when life sciences companies are strained for resources. Others worry that the system upgrades required by the move will lead to software incompatibilities. Still others wonder whether older submissions that need amendments will first need to be converted — a time-consuming and costly task.
How DXC can help you comply with eCTD guidance
Sponsors moving to eCTD for promotional materials require a clearly considered transition, one that captures both additional data and processes. Although the result is an electronic submission, some information and considerations related to AdPromo are omitted by the eCTDs. AdPromo services can help by leveraging DXC's deep experience in regulatory consulting, strategy, business process and implementation.
Specifically, DXC is prepared to help sponsors with AdPromo readiness, ongoing support and content reviews. Readiness bridges the gap between messaging and compliance with labeling, regulatory and business-process consulting. This helps sponsors gain visibility into all areas of the process for a smoother transition. It also improves communications with other functional groups upstream, fully addressing why you should establish a well thought-out AdPromo submission process.
Ongoing support means that DXC manages materials, including technical data, pre- and post-submission preparations, review and finalization. For content reviews, we provide structure and regulatory assistance in the form of advertisement reviews, content verification and participation on review committees.
DXC offers a five-step process that clients can choose from, based on their level of compliance in meeting the FDA’s submission requirement. Following these steps to upgrade to the new Module 1 requirements will give your company the ability to send AdPromo submissions electronically, leveraging the new granularity of both the FDA’s Office of Prescription Drugs Promotion and the Advertising and Promotional Labeling Branch. This upgrade also adds convenience, allowing your company to submit group submissions for not only AdPromo, but also your annual reports, labeling supplements and other applications. This, in turn, can translate into fewer submissions.
Step 1: Assessment. First, DXC helps sponsors with AdPromo readiness, in which our consultants provide labeling, regulatory and business-process services that enable more visibility into all areas and bridge the gap between messaging and compliance. Next, we offer our Advertising Content Review service; here, our experts provide regulatory reviews of advertisements, either directly or as part of a sponsor’s promotional-review committee.
Step 2: Planning. DXC consultants help sponsors perform gap analyses, answering the question, “How far is your company from AdPromo compliance?” Based on the results, we then help you determine the best plan for moving forward.
Step 3: Systems Upgrades. To comply with and manage new processes, some sponsors may need to upgrade and modify IT systems. DXC helps you first determine which types of upgrades or modifications are necessary. Then we help you plan, add and implement the needed changes.
Step 4: Process Development. DXC consultants first help map out a revised process for eCTD compliance. Then, to provide a smooth transition, they help ensure it’s fully implemented. This is focused on an upstream methodology supporting the end result.
Step 5: Implementation. Even after eCTD compliance has been achieved, a sponsor will likely find that additional implementation steps are required to accomplish metadata collection, life-cycle activities, and AdPromo vs. eCTD nuances. DXC completes the project with these services.
This is a multistep process that sponsors can engage at any step, depending on their level of readiness. Just starting with eCTD? Then let DXC help you with Step 1. Further along in the process? We can assist you there, too. In fact, wherever your company is in the eCTD process, DXC can help.