Most Common Areas of Pushback from Medical, Legal, and Regulatory Teams

Getting a promotional piece approved for pharma is about more than whether or not the ad has catchy content or visual appeal—which means the workflow is different, too. A pharma marketing timeline has to build in review from medical, legal and regulatory (MLR) to ensure that the information contained within a pharmaceutical ad, an e-blast to a physician, or a commercial on TV won’t summon an FDA cease-and-desist letter…or worse.

Obviously there are good reasons for the regulations that govern pharmaceutical promotion. If a pharma marketing team or an advertising agency is coming into a project with the intention to skirt those rules rather than accommodate them, they’re not going to get past the wall of MLR. Instead, the project will be lengthened because of contentious review sessions, internal debate with the team, and eventual resubmissions. The initial idea will most likely be lost in the shuffle entirely, leaving only lost time to show for the effort.

It’s best to not only have good working knowledge of the specific FDA regulations around promotional materials, but also to know where campaigns tend to fall afoul of internal MLR teams. That way you can manage your expectations during the ideation process and create something that can not only see the team through to the finished product, but take less time (and cause fewer headaches) as well.

In no particular order, here are the areas where we see the most pushback from MLR teams during our own review processes in partnership with clients:

#1 Pharmaceutical Efficacy Claims

This is the single biggest area where we see marketing teams clashing with MLR. Efficacy information that isn’t included on pivotal trials or in the product labeling might be appealing for marketing claims, but the regulatory risk is high. Even if the study in question is a well-controlled, peer-reviewed study, if it’s different from what’s shown in the labeling, eyebrows will be raised.

What’s more, if the efficacy information you’re grabbing for a claim is from the pivotal trials or official prescribing information, there are still ways to pose claims that are misleading. If you say “93 percent of patients felt relief,” for example, but don’t specify that this was only in one study, and that the other studies included on the labeling show lower proportions of patients experiencing relief, or that the number was only for one treatment population, or any other number of things that should properly contextualize the claim, you’ll run into trouble with MLR.

The problem is, it’s common to fixate on high-sounding efficacy numbers and build campaigns around them. Based on your understanding of the degree of risk tolerance your organization’s MLR team has, make sure your efficacy numbers are “load-bearing” before you go full-steam ahead.

#2 Promotional Fair Balance

Fair balance is another minefield we frequently see pushback with because these principles are open to interpretation and risk tolerances vary. Fair balance isn’t just about content, but also visuals. Is your piece chock-full of product claims? Are the related risks crammed on a tiny portion of the piece elsewhere? Do you have flashy product claims in bright colors and huge fonts? Is the important safety information illegible because it’s in a comparatively miniscule font? If the answer to all of these questions is yes, you may struggle during the approval process and end up going through rounds of redesigns or rewrites.

Fair balance is about ensuring that claims are accompanied by a fair accounting of the risks associated with a product. This principle is a cornerstone of pharmaceutical advertising regulations. Quantity of content and design both matter. Separating out the risk information from the benefits with design elements is also a no-no, because it makes it seem like the two sections are not related. The days of big borders between claims and risk information and warnings that you need a microscope to read are over.

Be proactive in displaying safety info when you’re making product claims, design thoughtfully and don’t go too small with fonts for risk information, and avoid demarcating the two categories of information to avoid falling afoul of your regulatory team.

Patient Testimonial Wording

Patient testimonial language is a minefield because human experience is varied and mediated by individual circumstances. Teams typically have a stable of approved messaging and claims, but patient experience is going to fall outside of how those things are said. Even still, patient experience can be highly relatable, impactful content for promotional pieces meant for both healthcare provider and patient audiences.

MLR (and we mean every part of the acronym here) will quibble over the words that patients use. Medical will have issues with the accuracy of terms used by patients touching on medical principles, legal will worry that the patient is implying a claim about the product that could be viewed as misleading, and regulatory will worry that someone at OPDP will see or hear a patient say a specific word and issue a warning letter.

Letting MLR review the questions you’ll be asking patients can help them isolate those areas where they anticipate trouble. Rephrasing the questions to sidestep those areas is a helpful strategy. Knowing what linguistic taboos exist ahead of time and guiding the patient to reword during live testimonial gathering helps keep this kind of information usable as well. Unfortunately, not every patient testimonial will be able to be used—and that’s okay.

Does your team have any areas where you frequently clash with MLR? At bfw Advertising, we have decades of experience walking teams through the more precarious aspects of the regulatory review process and coming through the other end with promotional materials that meet the needs of pharmaceutical and medical device companies. Get in touch to learn how we can help you build effective campaigns that avoid major MLR pitfalls and time crunches.