Pharma Marketing for Newbie UX Designers, Part 4: Regulatory Team
A 4-part series sharing my experience as a UX designer in the world of pharma marketing
Meet the Medical, Legal and Regulatory (MLR) Committee
Every time a marketing manager in a pharmaceutical company wants to create an advertisement for a drug, they need to get approval from the experts in compliance and regulatory. They are the Medical, Legal, and Regulatory (MLR) Committee, or some companies call them the Promotional Review Committee (PRC).
Every pharma company has an MLR committee. The MLR committee’s job is to make sure whatever the company produce is compliant within the FDA’s guidelines (also to prevent lawsuits). Everything, from a product claim, print brochure, video commercial, bus stop ads, to the digital sales aid and branded websites, needs to go through several rounds of rigorous reviews before the public sees them.
Although there are rules and guidelines from the FDA, most of them are for traditional media like printed advertisements or TV commercials. When it comes to digital materials, the rules can be fuzzy and each MLR team is the one to interpret them for their company’s product. They are the gatekeepers. They can be really conservative if the drug comes with higher risks, and the final materials would probably include many warnings and disclaimers in places that would not be overlooked by the audiences.
Fair Balance
One of the most challenging rules is that there needs to be “fair balance” of information describing both the risks and benefits of a drug. Traditionally in print brochures, designers will keep a certain percentage on every page to display safety information, so they can make sure the reader can easily see the side effects.
However, in the digital age when our screen sizes are fluid and websites are responsive, it can be difficult to determine what it meant to have a “fair balance”. Over the years, a general approach emerges for the drug websites, designers either place a horizontal bar that sticks with the bottom edge of the browser (example), or keep a portion of the right-hand area to show safety information (example). The same practice also needs to appear in digital sales aids.
Working with the MLR Committee
Every company is different, but in general the MLR committee members all have their own roles in other teams. They meet once a week to review all the materials submitted by marketing managers from all different brands in the company. Since a pharma company can be very large with many brands (like Pfizer), the MLR committee usually has a set rule of how things get submitted, when it would be reviewed, and how the action items are tracked after the review.
For example,
- If we need the material to get reviewed in the next round, we might need to submit it a week before.
- If we are submitting a website design for review, we need to make a screenshot collection of every page and put them together as one PDF file.
- For the reviewers to understand the functionalities, we need to annotate on the PDF how things work on the website and include any required information that’s not obvious in the screenshots, such as references or metadata.
- Once it’s submitted, we will need to wait a week for it to get the review, and wait for one to two days to get the reviewer’s notes back. This is one of the reasons why a pharma design project can have long and linear timeline while the design window can be actually quite small.
The MLR committee is composed of experts on compliance, but they don’t work for each brand. Therefore, when the reviewers are reviewing the submitted materials, they might not have all the background or context for what they are looking at. The marketing manager is usually the one to set up the review. They should explain the project background, context, objective, the submitted materials (is it a website screenshot or is it a web banner ad), and the current progress (are we looking at an early concept or final beta).
The relationship between the marketing manager and the MLR committee is critical in this process. A proactive manager who gives heads up before the review and maintains a close connection with the MLR committee can help smooth the process a lot. I’ve also seen a manager new to the process and ended up spending most of the review time just to set up the context.
Sit in the MLR Review
Depending on the MLR committee, agencies are not always permitted to join the review meetings. When we joined, our roles are often listening partners. Sometimes it can be frustrating when the reviewer doesn’t understand the intention of a design element and request to remove it. However, even if we can’t explain some design decisions, getting to sit in those meetings will certainly help us understand the MLR committee’s perspectives and concerns. Knowing that would help us design within compliance better next time. I’ve also participated in an MLR meeting where we got to demo the beta version and explain the functionalities. It was a fruitful relationship that our account manager and the client have worked really hard on.
Once the material is approved, congrats! But, that also means you can’t change what has been agreed upon. If it’s a concept review of the photography usage for a website, the team cannot change direction suddenly and use illustrations mainly. If you insist on changing direction that might result in another round of submission and review, which can be costly for your project. Therefore, it’s often difficult for agencies to have an iterative process. We mainly operate on a waterfall process to work with the approval requirement and maintain cost-effectiveness for our projects.
Conclusion
With all the constraints, designing for pharma marketing can make designers feel limited and frustrated at times. That is why it’s even more important to understand each stakeholder’s needs and concerns. No matter who you are working with, the marketing manager, the sales reps, or the MLR team, it is impossible to get all the information you want before starting designing in the waterfall process. I hope that by providing you some basics, I can help you jump start with a better understanding. It can be very rewarding when your design idea helps explain a complicated science concept with an elegant solution. Good luck with your journey in pharma marketing!
This article is one of my 4-part series sharing my experience as a UX designer in the world of pharma marketing. See the full list here:
