If you were under the impression that life sciences companies are holding off on adopting the new eCTD Module 1 guidance for advertising and promotional materials, think again. It turns out that since the Office of Prescription Drug Promotion (OPDP) started accepting electronic submissions in June 2015 through the middle of February 2016, it has received 400 AdPromo submissions containing more than 1,000 promotional pieces.
In addition, the Advertising Promotional Labeling Branch (APLB) has received close to 6,000 Form FDA-2253 submissions from fiscal year 2010 through 2015.
By Karen Stith, Professional Regulatory Writer, CSC
It was only a few months ago that word across the industry was that only a few submissions had been received, but the presentation from Roberta Szydlo from the ODPD during the DIA Marketing Pharmaceuticals 2016 conference shed new light on the matter.
Given this flurry of activity, this is a good time to recap what changes the guidance contains, how these assist the way FDA reviewers work and what benefits – as well as commitments – the guidance provides to companies. It’s also an opportunity to offer some advice on where to begin.
As I mentioned in my last blog, the granular format of eCTD AdPromo submissions improves manageability and helps companies more clearly and succinctly organize their information. Nevertheless, companies have held back in part because they think it will involve more work and resources, partly because of lack of clarity in some areas, and partly because they are worried about the unknown, such as running into possible technical issues.
Playing It Safe
Of the 400 submissions to OPDP, there have been a few rejections, mainly due to sponsors submitting their AdPromo submissions using the older software version and due to the submission ID number being used incorrectly, as stated by Szydlo.
In addition to rejections, AdPromo reviews have been delayed which was mainly due to the Package Insert (PI) and/or cover letter/correspondence being placed in the incorrect location.
While the guidance is pretty clear, there are some areas which are a bit vague, such as how to deal with the possibility that companies may have formats that fall outside of those specified in the guidance. However, FDA authorities have made it clear that they want companies to notify them if they have formats that are more suited to their specific situation than those outlined in the guidance.
The agency is seeking open dialogue and is providing some leeway for companies. For example, with television the FDA was asking for storyboards, but this is a format that many companies aren’t using, so the agency has said companies can provide still images or video that shows the various sides/angles of the promo material.
The commenting period for this guidance has ended; however, the FDA will take on board those comments received, make a determination, and may update the guidance and clarify statements to remove ambiguity.
Understanding What’s Changed
The new guidance describes agencies to which companies submit and the requirements on paper vs. eCTD, as well as advertising content requirements. The biggest changes are first and foremost that companies can now submit eCTD to OPDP via the new Module 1 and can use the gateway to do this.
During the conference, Szydlo mentioned that the ability to submit the 2253s and non-2253s via the gateway is a benefit to the agency as it will allow reviewers to assess the submission more rapidly. However, those at the conference noted that the agency is taking significantly longer than the 45 days specified in the guidance, and in fact is taking between 90 days and 6 months. Nevertheless, this process is still faster than submitting by paper.
Other changes are that the FDA can now do searches of the submission to extract the information they need, and due to extensive metadata collection can allow submission information to be populated into tracking software. FDA has more insight, and now with AdPromo being eCTD, companies can easily link to the various applications in order to have better oversight and improved decision making.
With so many companies now submitting and the FDA ready and willing to assist, the question companies need to be asking themselves is: What’s holding us back?
You need to start by reviewing the new guidance and becoming familiar with the granularity changes and the extensive use of metadata now required. A test submission to OPDP is something you should highly consider. The test will allow you see how all the information in the submission relates and gain valuable feedback from the FDA that you can apply going forward, which will also help you fine-tune your company processes. Test submissions to APLB are not being reviewed as they have already been accepting advertising and labelling submissions via eCTD for years.
The purpose of greater granularity and increased use of metadata is to lead to a validated submission, so ultimately while it might seem like additional work, the outcome is to your advantage. g the route of an Advisory Comment Submission if you can fit the “response waiting time
Another valuable step to take with your AdPromo submissions is to consider takin” into your submission schedule. While you might wonder why you should bother going through the advisory step when you can go straight for the approval, it will help you to learn how the FDA thinks, build a report, avoid rework and possible warning letters, and apply the agency’s comments across the board.
Listen to the on-demand AdPromo webinar to learn how you can begin your eCTD AdPromo journey and take a leap into the future.