Taking the Pain Out of the Medical, Legal, & Regulatory Review…Maybe

By Sue Iannone

“It’s like pulling teeth.”

“I’d rather stick a needle in my eye.”

“About as much fun as a box of razor blades.”

Those are all colorful expressions, for sure.  If you asked 10 people from biopharma L&D teams what they think about the Medical, Legal, and Regulatory (MLR) review process, you’d probably hear similar comments.  For marketers and L&D pros, the MLR review process can be seen as a real drag on progress—an obstacle to be overcome.  Well, the fact is the MLR review isn’t going away anytime soon, so it’s probably a good idea to make the best of it.  In this article, I want to help you do that.

Why the MLR Review is Important

Whenever L&D, Marketing, or some other team develops content or materials, those materials need to go through the MLR review process.  Typically, the MLR Review Team is responsible for conducting this process.  The review team members are most often people from—you guessed it—the Medical Affairs, Legal, and Regulatory departments.

Collectively, it’s their job to make sure that any piece of communications or training content developed by the company:

  • Is medically accurate
  • Complies with the applicable regulations
  • Doesn’t communicate anything that will put the company, patients, healthcare providers, or others at risk (legal or otherwise)

When it comes to marketing materials, the need for some type of MLR review is readily apparent.  Customers and other stakeholders who are external to the company will see that content, so it’s important to make sure it passes muster.

MLR review is important for training content too.  Even though training programs are for internal use, they often train sales representatives and other externally-facing personnel how to communicate key messages.  So, a lot of internally-facing training content is ultimately externally-facing.

Why the MLR Review is “Hated”

“Hated” may be too strong a word, but many content developers really dislike it…a lot.  Why is this the case?  In my experience, it comes down to three reasons:

  1. The Time – Simply put, it often takes too long. There are a number of factors that can delay content development.  However, the MLR review is one that’s always there, standing between a proposed piece of material and a finished project.  While the MLR review can take as little as a week, it can also take months if it involves a lot of feedback and results in an iterative process.  The time required depends on how busy the review team is and the type of feedback they provide.
  2. The Changes – In many cases, content developers feel like MLR reviewers end up “sanitizing” the content so much, that it loses a lot of its meaning and impact. Once the lawyers get hold of something and scrub it of all potentially risky / controversial / borderline / “gray area” content, then—the concern goes—there might be nothing left!
  3. The Reviewers – I hesitate to write this one because I don’t want to paint with too broad of a brush.  But, sometimes the review team members themselves can be less than amicable when dealing with the L&D and/or marketing personnel who create content.  This is certainly not always the case.  But it is in some situations.  It’s important to remember that most review team members basically do that “on the side,” in addition to their daily responsibilities.  They’re typically assigned MRL review duty and they can sometimes view it as a nuisance.  That can occasionally show through.  In other cases, reviewers can become defensive, as some have been “burned” in the past when working with content developers who try to force as much borderline material through as they possibly can.

Making the Best of the MLR Review Process

The things to remember are:

  • You can’t change the process. The MLR review will be here until the sun explodes.
  • Most likely, you can’t change the review team.

Given those truths, here are three suggestions for making the best of the MLR review process:

  1. Adopt a positive attitude and mindset – It’s easy to adopt a negative mindset when it comes to the MLR review process. However, resist that temptation. Remember that both you and the reviewers want what’s best for the company.  You’re all on the same team.  Work to build a rapport with the review team members and develop long-term relationships.  Viewing your interactions with them as a joint venture—rather than an adversarial relationship—will make a difference.
  2. Create forecasts for the review team – Some L&D teams develop forward-looking plans outlining the new programs and materials that will be coming to the review team. However, many don’t.  It’s definitely a good idea to create a plan and share it with the review team ahead of time.  They’ll appreciate the effort, it will give them advance notice, and it will help avoid surprises.  It will also be good for you, as the act of writing the plan will force you to think about timing, and to build in enough for the MLR process itself.  Develop the plan to look ahead as far as you realistically can.  For some, this may be a plan for the next POA meeting or quarter.  Other teams may be able to look ahead a full year.
  3. Share concept previews – Generally, it’s best if you can sit down with the review team and share your ideas or concepts for a program up front. If needed, you can also involve your relevant vendor(s) in the meeting.  This approach enables the review team to give you some “pre-feedback” that you can use when you develop your material.  Doing this can definitely reduce review times—and the number of iterations—on the back-end.  It can also potentially save you dollars.  If you are working with a vendor that charges for numerous review rounds,  a concept review can help set you and the vendor off in the right direction and avoid extra rounds of MLR review.  It’s also a great way to further cement your relationships with review team members.

The ideas above should help improve the MLR review process for you.  However, they’re no guarantee.  Sometimes, the MLR review can be difficult and frustrating no matter what you do.  But, if you follow the suggestions above, it will make the process better and more productive over time.

What about you?  Do you have any ideas or suggestions for improving the MLR process?  If so, share them in the comments section or send me an e-mail at sue@bullcityblue.com!

 

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