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How I Survived the Ultimate MLR Nightmare: 7 Essential Steps for Med-Legal Success

Whether it’s called PRC, PRT, PRB, RC, CCC, or any other acronym, the Medical Legal Regulatory, or MLR,  process at pharmaceutical companies can be one of the most frustrating and painful experiences for brand managers and their advertising agencies. During one particularly challenging product launch at one of my former employers, the MLR team spent 8 hours in a single day reviewing two paragraphs of an 80-page document. Not surprisingly, this nightmare scenario proved to be one of the most frustrating days in my professional life. One of the primary reasons for this day-long endurance test was that one of the approvers was actually the scientist who invented the product! His in-depth knowledge of the product was sometimes at odds with the published literature about the product which led to many long and animated discussions.

Certainly having the inventor of a drug attend an MLR meeting is a rare event, but the butting of heads at these meetings is all too common. By its nature the MLR process is adversarial, as Medical, Legal, and Regulatory personnel strive to ensure that pharmaceutical promotion is accurate, ethical, and compliant, while we as marketers defend our messaging and tactics to ensure that promotions and advertising are pointed and impactful.

That being said, with proper planning, you can minimize the friction of your next MLR meeting and even  turn it into a productive, collaborative, and efficient engagement! So, if you want to minimize the times you are in the crosshairs at your review meetings, consider the following seven steps for proven MLR success:

1). Be Accurate
It seems obvious, but it can’t be said often enough – ensure your copy is accurate and supportable by the references you provide. This means that every claim, assertion, and statistic about a drug or medical condition mentioned in promotional material be supported by a reputable or peer-reviewed reference. In addition, the specific copy that supports your claims should be clearly highlighted or otherwise identified. If the stat in your claim says 83%, the stat in your backup should say 83%. If there was some calculation done to arrive at 83%, show your math. Each time you present inaccurate or unsupported data, any trust you may have won with MLR takes a hit.

2). Call in the Copywriters
When submitting new or complex copy for review, consider having your copywriter attend the review meeting. It is far preferable to have the copywriter or someone from the agency draft new copy based on MLR feedback rather than have a lawyer or regulatory expert craft promotional copy. What one professional who drafts contracts and another professional who writes sales material consider engaging, effective writing are frequently two different things.

3). Sell Innovative Ideas
In addition to the copywriter, ensure that any experts you need are present to explain what your submitted content says and how it is intended to be used. These experts can help sell your copy, especially if it is innovative or “pushes the envelope.” If your copy addresses reimbursement issues, try to have the reimbursement expert available to answer all MLR questions. If you are submitting a call center script, have the call center manager available to answer any questions or receive any feedback directly from MLR. Most important, if you are submitting materials as part of the digital campaign, have your digital expert available to explain the functionality—whether it offers new advantages or poses some limitations—of your Web site, interactive visual aid, or other digital item. Having the most knowledgeable person familiar with your content or tactic available is critical in ensuring that inaccurate or ill-defined copy is not approved, leaving you with no alternative but to return to MLR to re-review corrected copy.

4). Pick Your Battles
Defending your work is typically second nature to anyone who produces creative material. And anyone who submits materials for MLR review should be prepared to explain every word that appears in their copy. It may, however, be prudent to know when to accept an MLR change and know when to hold your ground. Don’t be too quick to voraciously defend everything you submit. Save your energy and goodwill with MLR by only choosing the most important claims or approaches reflected in your copy. These include the underlying premise of your campaign, claims that span numerous tactics, or concepts that effectively counter competitor claims or that tested exceptionally well in market research. Accept smaller, less significant changes graciously to allow the MLR personnel to save face and to gain goodwill with them. Given the somewhat large egos that physicians and lawyers can have, this may make your future encounters with them more congenial and, therefore, more mutually beneficial.

5). Show the Big Picture
As promotional campaigns frequently comprise multiple tactics that are reviewed by MLR teams in numerous meetings over weeks or even months, it is helpful to provide a documented description of how the tactics complement or fit in with one another in the overall campaign or project. For a campaign that entails direct mail or a series of emails, provide a list of each item, what its purpose is, when it will be deployed, and any other information that will allow MLR reviewers to provide feedback both in the context of the overall campaign as well as for the individual piece. This will minimize the likelihood of MLR revising copy in one piece that sets up inconsistent messaging in the next in the series or that unnecessarily duplicates copy in two or more items in the series.

6). Get In – Get Out!
Unless otherwise instructed, you as the marketing representative should serve as the sole advocate for the item under review. If agency partners are allowed to attend or listen in to the meeting, they should only answer questions when asked. Avoid providing information that is not requested. Your goal is to have your item reviewed and approved as quickly as possible. Do nothing that may extend the time the piece is in active review by MLR.

7). Win Friends, Influence People
Identify the most influential or assertive member of the MLR committee, and strive to form a strong relationship with him or her. Typically this person is the attorney. Building trust with this person may not help in convincing him or her to not change your copy in an undesirable way, but it may result in your gaining the benefit of the doubt in situations where MLR is on the fence regarding a statement or concept. Having the team member with the most strident personality on your side may help in gaining agreement from other members of the MLR team.

Conclusion
By its nature, the med-legal review process will never be easy. However, as we’ve seen, there are a number of practical steps you can take to help make the process go smoother. So before your next meeting, remember to follow these seven essential steps for med-legal success:

1). Be Accurate
2). Call in the Copywriters
3). Sell Innovative Ideas
4). Pick Your Battles
5). Show the Big Picture
6). Get In – Get Out!
7). Win Friends, Influence People

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Lewis Adams
With more than 15 years of pharma editorial experience, Lewis provides expert guidance regarding regulated promotional items. His specialties include medical editing. project management, vendor management, as well as expertise in patient assistance program and 501(c)(3) organization management. He is a graduate of the University of Pennsylvania.

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