Working at an agency, there are already plenty of hurdles we have to overcome when trying to build a portfolio or book of business. For agencies conducting business with pharmaceutical, biotech, medical device or really any highly-regulated industry, there is another layer of difficulty to conquer; that of the complex MLR (Medical, Legal, Regulatory) process. Experience and knowledge working with MLR is not necessarily a requirement for agencies, but surely will give your team the upper hand if you’re looking to play in this space. Below you’ll read our tips for how to effectively work with companies that require comprehensive MLR reviews. Let’s first outline the different shareholders who comprise MLR and their priorities. 

FDA - The Food and Drug Administration1,4 

Goal: The Food and Drug Administration is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. They are primarily focused on the overall public health and how best to protect it. The FDA also is responsible for regulating products when it comes to tobacco, cosmetics and food supply. 

Providing accurate, science-based information to the public is where the agency world and MLR intersect. Fair and balanced messaging in these marketing materials is a necessity. The pharmaceutical drug and medical device benefits must be reasonably similar in content and presentation as the outlined risks. Being abreast of the guidelines that come along with promoting within these industries will minimize the number of MLR review rounds required. In turn, variable project costs like rush fees or overtime can be controlled with more confidence. 

OPDP - The Office of Prescription Drug Promotion2  

Goal: Alongside the FDA, there is The Office of Prescription Drug Promotion (OPDP) which consists of a team of researchers who review the direct-to-consumer (DTC) and professional promotional prescription drug materials. This research team is designed to investigate both applied and theoretical issues. OPDP’s research supports the Food and Drug Administration’s (FDA) goal of science-based policy while maintaining its commitment to protect the public health. The OPDP research team also provides technical assistance to outside organizations on the design and implementation of studies concerning prescription drug promotion. 

Promotional Review Committee (PRC) or Medical Legal Review (MLR) Committee 3,4

Goal: The PRC/MLR team ensures any promotion of a pharmaceutical product is medically accurate and complies with the regulations of the Food and Drug Administration (FDA) and any other applicable laws and regulations.

  1. Medical: These individuals typically work in the Medical Affairs department and often have terminal doctorates such as a Doctorate in Pharmacy, Medicine or PhD in the life sciences. They are expected to review a proposed piece to evaluate whether it is compliant with FDA and Federal Trade Commission (FTC) expectations and the approved package insert. 
  2. Legal: These individuals are attorneys and typically work in the legal department, although occasionally called the compliance department. They may be asked to evaluate if the proposed piece or program might violate a number of laws, including HIPAA, the False Claims Act, Anti-kickback law, pre existing agreements, etc. Responsible for counseling on FDA regulatory matters, product life cycle, executing commercial and government contracts, employment law, corporate transactions and governance.
  3. Regulatory: Regulatory affairs acts as an interface with health agencies and is the go-between for company departments. They are also the leading team to provide strategic advice and decisions during the entire life of a drug. Regulatory professionals work to meet regulatory commitments with the health authorities. The maintenance of the marketing license for the drug and product life cycle activities are led by the Regulatory team. This can include expanding the indication of the drug, formulation adaptations, changes in the dosage etc.

Marketing / Brand Managers4,5,6 

Goal: Brand managers are focused on creating a market of consumers to improve product sales and overall market shares for the company. Oversight of trends in the market as well as marketing activities around the brand are monitored to ensure the right message is continually being delivered. The primary differentiator being the MLR review process which ALL external marketing / promotional materials must be passed through. Marketing teams have not only limited capacity, communication tactics and market channels in which their messaging can be promoted through, but the content itself is highly scrutinized before hitting the general public. Remember that, “fair and balanced” requirement? This greatly impacts the way brand managers can position the benefits of their products and how it can be sold. 

Depending on the complexity of the communication and messaging, MLR review cycles can last anywhere between 30 days to 6 months. This is due to the level of accuracy, quality and integrity required of pharmaceutical and biotech companies to uphold in their promotion of drugs and products.  Life science companies, including drug and device companies, have paid multi-billion-dollar fines resulting from non-compliant promotion.

Challenges: Time, industry resource reductions, competing initiatives, shelf-life of product claims / campaign effectiveness, consensus and buy-ins from medical agencies and departments. 

Needs: Communication, Documentation, Automation, Organization.

Now that we’ve got a better understanding of who does what and why, we can be intentional with how to best work with and service the overall regulatory process. Being an external resource or outsourced vendor doesn’t always set the stage for constructing a trustworthy partnership. Remember, it’s easy to use the lack of internal visibility or understanding as a scapegoat when projects get off track due to MLR. Embracing the process and leaning into the PRC/MLR workflow will align you more closely with the heart of the operation. Below are 3 areas to focus on that take into consideration the needs, challenges and risks of your clients who require coordination with the FDA: 

Trust / Relationships7:

  • Schedule concept reviews. Before you’re in the throes of creative or development, reviewing the project brief with PRC is a great starting point. It shows that you’re looking to be a partner and respecting the requirements of MLR. Getting buy-in on the project goals, initiatives and deliverables will prep the reviewers when it comes time to be assessing and approving the materials. 
  • Ask for F2F time outside of scheduled PRC meetings. While the time constraints of MLR are real, gaining access to key individuals will allow you to get ahead of submission requirements and best practices when it comes to the review process. This could be as simple as a lunch with a PRC coordinator or the point person who manages the review schedule. Again, the key is to stand-out and show your value add to your client. The more time invested in the set-up, the bigger the payoffs when it comes to the project work. Building those relationships and understanding the way their MLR committee functions will give your team an advantage. 
  • Get to know everyone in the department and their job functions. The more you’re able to align with the departments and internal workings of your clients, the more seamless the transition into executing the work. We’ve all experienced projects when our POC acts (intentionally or not) as a bottleneck. If you’re able to facilitate workflows and communications directly with their counterparts, you’re not only helping your team execute efficiently, but also making your POC’s life easier. We will note here, there will always be those clients who do not want their agencies going outside of their purview, so we always recommend transparency before doing so. 

Communication / Ownership7:

  • Attend all calls + review meetings. Dedicate time and show up in person if this is an option. Sometimes MLR reviews can last 4-6 hours long when there are many projects on the docket to be reviewed. While that can seem inconvenient, immersing yourself in these reviews real-time can help save time on the backend. When you’re able to answer / speak directly to MLR’s questions/requests, it’s not unheard of that comments can get settled right on the spot. This cuts down on the amount of time your team will need to spend on revisions and also help document what needs to be done to get approved on the next submission.  
  • Don’t feel the need to channel everything through the brand manager. Work directly with PRC/MLR/coordinators to accomplish things more quickly/directly. You can keep your POC in the loop via status calls, but they might greatly appreciate the proactive measures to keep projects on track and on timeline. Most of the comments/annotations that come from MLR sessions are open to interpretation and not always prescriptive. Therefore, having direct communication with their team can help facilitate quick answers, which will allow your client to not get bogged down in project details or hold up the overall timelines. 
  • Bring examples of failures + successes. This is in line with scheduling concept reviews at the onset of a project. As you’re scoping the project and getting stakeholder buy-in, as many examples you can bring to the table during reviews, the more likely MLR will be open to hearing your suggestions. It might not always work, but again, it shows the extra effort and the consideration that’s taken around the looming risk for any reviewer. You can minimize and mitigate risk by showing them through examples why this initiative or project is in their best interest and ultimately be required in order to protect the company. 

Education / Research7: Become an expert in the space! These are all suggestions that can be applied not only at the client level, but across your agency. 

  • Get certified in the regulatory review platform
  • Attend trainings put on by the MLR committees 
  • Propose workflows / document processes improvements 
  • Schedule recaps to capture feedback for the next MLR submission 

Whether you’re looking to grow professionally or just want to make day-to-day work easier, investing in training and education will pay off. Heck, you might even be able to get some blog content out of it. 

Sources: 

  1. https://www.fda.gov/about-fda/what-we-do
  2. https://www.fda.gov/about-fda/center-drug-evaluation-and-research/office-prescription-drug-promotion-opdp-research
  3. https://www.omicsonline.org/proceedings/role-of-regulatory-affairs-in-the-pharmaceutical-industry-7533.html
  4. https://www.kulkarnilawfirm.com/what-is-an-mlr-board-and-why-should-i-care/
  5. https://www.metromba.com/2017/05/pharmaceutical-brand-manager/
  6. https://www.cognizant.com/whitepapers/taking-control-of-the-mlr-review-process-codex2522.pdf
  7. https://www.mmm-online.com/home/channel/features/regulatory-whos-afraid-of-mlr/ 

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