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8 Tips for Regulatory Submissions

8 Tips for Regulatory Submissions

It’s MLR day. The review will either go incredibly smoothly, or it will be painful. Based on the 53 comments on the piece that you slotted for a 30-minute review, we’re leaning towards the latter. On top of it all, the piece features an actual patient, and reviews on patient content can be difficult to navigate. At this point, our advice is to get yourself a large coffee and get ready for rebuttal. Promotional pieces featuring real patient stories shouldn’t be scary. The good news is, after reading this, you’ll be better prepared for your next submission and review.

When it comes to getting custom patient content approved, the WEGO Health team has done it all. From unbranded videos to microsites to completely branded social media ads, we consider ourselves experts at receiving that blessed email with the subject reading, “Approved for Distribution.”

With over 13 years of MLR experience and thousands of patient content pieces approved, we’ve learned a few tricks of the trade that help keep programs moving through the regulatory process as smoothly and quickly as possible. Picture a non-scripted patient video going through review and receiving zero comments. Yes, it’s as beautiful as it sounds. And yes, we’ve done it. Quite a few times.

You can do it as well, and below are the top tips for getting patient-centered materials approved by regulatory.

When in doubt, “concept” it out. Before beginning a new program that features patients, it’s always best to kick-off the program with a concept review. This will help you to learn the questions or concerns that your review team will have. You should leave a concept review with a green light from all parties involved to proceed with the program, along with clear guidelines and instructions that will ensure your first formal submission is properly formatted. A concept review ensures that the regulatory team truly understands the program and won’t have any conceptual questions when you submit your formal pieces.

Examples can be your best friend. If you can share examples of a finished product to get MLR to fully grasp your program, do it. Whether it’s internal examples or examples from other companies or brands, regulatory teams like to know they aren’t alone in what they are reviewing and approving, and that similar content has been approved. However, if you’ve sat through any reviews where examples are reviewed, you may hear, “I don’t care about these examples and what other teams are doing.” At that point, abort the example mission and carry on.
Essential asset gathering is key. Incorporate high-resolution logo images, follow company style guides, and leverage social media templates to ensure that submissions are following the latest guidelines.

Don’t recreate the wheel. Regulatory teams are more comfortable reviewing content that is in a format that they are familiar with. If you’re trying to get promotional copy approved, see if there are templates that have been approved in the past that you can use when creating your submission document.

Embrace the annotation station. In all submission documents, if you’re trying to depict actions users can take on a piece, like clicking to play a video or hitting “share” to send to a friend, and those actions for users to take are not annotated, the piece will be kicked back to you. For example, if you’re trying to get promotional copy approved and have an example of an in-feed ad, clicks, likes, shares, and/or comments must be annotated to inform reviewers what actions can be taken. When in doubt, provide extra images and/or video to use as demos to explain available actions as thoroughly as possible.
Have offline discussions with an MLR team lead. Getting ready to submit a new piece from a new program for review? If so, one tactic we’ve worked with clients on is to try and schedule a call with the regulatory lead to walk through the format of the document. A lot of times they can point out potential red flags prior to a submission, which can help save your review timeline. This is also an opportunity to refresh their memories of the program, especially if the concept review was weeks or months ago.

Understand the patient relationship. When working with patients, it’s crucial that you understand every aspect of the relationship with the patient. For example, is the patient being compensated for their time? How much are they being compensated? Have they signed a contract and if so, who owns the contract? These questions typically arise during a review or concept review, so be prepared to answer the questions.

Vetting of patient content, or else! In addition to understanding the patient relationship, complete vetting on the patient’s social media channels. You want to ensure that this patient isn’t online talking about inappropriate topics, or posting, “I hate [INSERT YOUR CLIENT’S BRAND HERE]”. The last thing you want is to submit a patient profile for review and have someone from regulatory click on their Instagram feed to see borderline pornography. Save yourself some embarrassment, and do not skip any vetting.

Partnering with patients is no longer a nice to have, it’s a need to have. Brand teams need not let their fear of a complicated MLR process prevent them from creating user-generated authentic content that best resonates with their community. By following these tips, can you bring compelling content to life and not lose credibility with your MLR team.

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