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  • 1.  Marketing material Medical, Legal & Regulatory (MLR) review?

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2021 10:51
    This message was posted by a user wishing to remain anonymous

    Does your organization have a Medical, Legal & Regulatory (MLR) Team for Marketing material review?  Is it a dedicated (fulltime/Team based) group, or just folks from different areas who are designated as working on an MLR Team?  Also (if applicable), has any organization gone from no designated MLR Team, to a designated one or dedicated one?  Advantages seen thereafter?  Disadvantages?  Hopefully, review turnaround times have improved (average time then and now?), but do let me know.  Thanks a lot.


  • 2.  RE: Marketing material Medical, Legal & Regulatory (MLR) review?

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2021 16:31
    This message was posted by a user wishing to remain anonymous

    [assuming this is for a medical device, not drug, which would be different]

    I have seen this organized all sorts of different ways in different companies.  What I prefer is for the regulatory person closest to the technology to act as the lead reviewer, acting as a "filter" for additional reviewers, with legal mandatory on certain types of promotion (such as reimbursement info, pricing/rebates, direct competitive claims, or other high-risk claims).

    So all promo reviews require marketing and regulatory, some require marketing/reg/legal, and for all others reg has the authority and responsibility to call for reviews from other functional areas (R&D, clinical, reimbursement, legal) as needed based on the material being reviewed. 

    Of course, all of this is described in a detailed procedure, and only works if you have experienced reg people running this process who are expert on both the product and promotional issues/enforcement trends.
    Original Message


  • 3.  RE: Marketing material Medical, Legal & Regulatory (MLR) review?

    Posted 07-Dec-2021 18:41
    Large MedDev company here.

    For most divisions and business units, we have dedicated RA personnel that do all and only the reviews/approvals of promotional materials. We work in a matrix style with other functional entities (Legal, Medical, Clinical, R&D, Customer Service, Training, HE&R) based on the content under review. An Approvers matrix (minimum SMEs and criteria for additional SMEs) in a well documented SOP ensures a smooth process. 

    As mentioned previously: RA/Marketing/Marcom are the minimum required. Doc Control is involved by default as A&P is part of the QMS. 

    • Advantages: dedicated personnel with quick turnaround times as well as less distractions from other RA responsibilities (e.g. submissions deadlines). Ability to hone in this as an expertise (internally and externally). 
    • Disadvantages: some RA might not like the narrow focus or working in the grey zones. In our case, most of us have done all the other RA roles (over a decade experience) and this is a chosen career path. 


    ------------------------------
    Jennifer Ng Ain Kin
    Regulatory Affairs, Advertising and Promotion
    Santa Clara CA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Marketing material Medical, Legal & Regulatory (MLR) review?

    This message was posted by a user wishing to remain anonymous
    Posted 09-Dec-2021 11:15
    This message was posted by a user wishing to remain anonymous

    I have seen it done both ways. The advantage to having the RA core team representative review materials is that they understand the product well. However, in my experience this advantage doesn't outweigh the negatives. Ad/promo review is probably the most subjective area in RA, and having too many different RA representatives leads to a lot of inconsistencies. On top of that, ad/promo is often a rushed request, and a busy RA team can cause bottlenecks. And there are many nuances to learn for a given product category's ad/promo.

    So I typically prefer to have a separate RA representative who does all or most of the company ad/promo review. It's not uncommon to transition from having no team to having a dedicated team. To do so, you have to make sure the department communicates well so the core team RA rep and the ad/promo RA rep can work together well. Ideally, if both work together on an initial claims list or matrix, then it is easier to transition from the core team to the ad/promo review. In addition, you need to make sure the dedicated ad/promo reviewer or team really does have the ability to focus. They can have other responsibilities but too many. 

    Of course, all of these pros and cons depend on the type of product you sell. If it is very complicated, if it is marketing for home use vs. professional use, etc. - all of these may tip the scales as to which structure will work best for your company.
    Original Message


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