Don’t let disappointment from medical, legal and/or regulatory putting the kibosh on an idea or content get you down. Instead, get prepared! Here’s five ways to help you get what you want from MLR (aka PRC [promotional review committee in the US]:
#1. Provide extensive context
We all know that MLR reviews a ton of assets from every function of a company. However, despite knowing this fact, most items submitted for review still lack enough context for this team to understand the nuances of the submission. Filling in the bare minimum for the metadata in Veeva is just not going to cut it, if you’re trying to do something perceived as a bit exotic (which seems to be the case for anything beyond a press release). Think about it — MLR’s entire reason for being is to mitigate risk. For this reason, they will always be extremely cautious and go to the place of wrapping content up in medical jargon and disclaimers, without thinking about the impact this will have on the material’s usability.
For example, let’s say you’re submitting a physician byline for a US trade publication for review. It’s critical to explain in the metadata or a header on the document who the audience is for the byline, how it’s going to be used by the trade publication and why it needs to be formatted in a specific way. MLR isn’t going to magically understand that since the byline placement was earned, a drug’s important safety information (ISI) can’t be slapped at the end of it. In their minds, the ISI needs to be on ALL material and they won’t understand the nuance between how an ISI is used for owned/paid media vs. earned media without an explanation. However, publications will often allow a link to the ISI embedded in the first instance of the drug name or to be included somewhere at the end. To save everyone a lot of pain, it’s best to explain this type of dynamic upfront to give the content the best chance of being approved in a state that can actually be used for the intended purpose.
#2. Reference EVERYTHING
Most people reference documents by supporting the most major claims and aren’t particularly picky about the references themselves or annotating interpretations such as calculations. Well, we’re here to tell you that if you reference a document within an inch of its life, you’re going to get a lot less push back from MLR about what you’re trying to communicate. A few tips:
- Reference exclusively with primary sources and if not available, use a very credible secondary source, preferably one that has been peer-reviewed. If you don’t remember the difference between source types of or how to reference, check out our extensive guide on referencing for healthcare communications.
- If you want to use specific language that is not in a peer-reviewed reference, but has been published somewhere credible like a patient advocacy website, use both and include an annotation explaining that you’ve included a reference for content and another for language.
- Make sure the reference is geographically relevant i.e. if the material is about a European patient population, don’t use a reference about an Indian population published in an Asian journal.
- Don’t use outdated data/references. Try to use sources that have been published in the last 5 years.
- If you’re interpreting the data, make sure to include your calculation as an annotation to reviewers, otherwise they’re going to look at the source material and look at the claim and think nope, doesn’t match.
#3. Schedule a live concept review
Before spending a second doing the work, get MLR on a call and talk them through your project idea. Odds are that once they get the voiceover explaining the rationale and how it’s going to work, they’re going to be far more receptive than if you go off and bake the entire piece of work and submit it for review. Once again, it all comes down to providing MLR context and bringing them along on the journey so they can input and get comfortable.
This is also a fantastic time to find out what may keep them up at night about a specific idea so you can address whatever it is proactively as the idea/content is being developed. i.e. specific language choices, disclaimers, etc.
For example, if you’re working on an influencer campaign or capturing a patient story and don’t want the content to come off stiff, create a framework with MLR of what can and cannot be said. This also helps to manage expectations that the piece is going to be more natural, won’t follow a script and can’t be edited as long as it doesn’t violate the framework.
#4. Establish precedent
Let’s say what you want to do is completely new to a company and it’s pretty likely the answer from MLR is going to be a hard “no” even with a live concept review. To give yourself the best chance, research who else is doing said tactic and bring examples to a live concept review. The best precedent is going to be in the pharma/healthcare industry because that’s closest to home; however, picking examples from other regulated industries may still help. Essentially, MLR will feel comforted that no one was fined for being a bit innovative. Or, if a company was fined, then understanding why and how to avoid a fine, is helpful.
For example, we wanted to run an influencer campaign about a skin condition, but not all the influencers had visible symptoms. We knew MLR’s stance was that imagery must show the skin condition. We researched disease areas that have physical symptoms and put together a deck of influencers who suffer from diseases with visible symptoms, but didn’t have the symptoms visible in their sponsored social posts. Seeing the precedent significantly softened MLR’s stance so we were able to do the campaign.
#5. Review in steps
Another way to help MLR is to have them review material in steps. This is recommended for anything that requires a live review or establishing a precedent, or will involve a lot of artworking, animation or video. What we mean by steps, is outline everything in a word document first. We like to create two or three column documents to explain in detail what the imagery will look like or a voiceover will include to give MLR a chance to weigh in before production. In the event, MLR has major feedback that would compromise the usability of the asset, then this is the best time to chat through concerns on both sides. Otherwise, a lot of money may be spent on producing something MLR won’t approve for use.