Ideas by Bridgeable

Working together to produce a picture-perfect Medical, Legal and Regulatory review

Imagine a film set. The director and cinematographer are chatting about camera angles. The gaffer lights the scene while the set dresser makes last-minute fixes. The makeup artist adjusts the wigs, and the assistant director impatiently urges everyone to start shooting. Suddenly, the script supervisor notices something is not quite right about the costume, and adjustments must be made. So, it’s back to the dressing room… You can feel some tension between the different roles, but it is a creative tension. Each brings unique expertise, professionalism, and slightly different priorities. Still, they all have one shared goal: to create the best possible scene within the defined budget and time constraints. At its core, the Medical Legal Regulatory (MLR) review for patient communication materials is a collaborative process, much like a film production.

What is an MLR review?

The MLR review, also called Promotional Review, is a mandatory step for creating public-facing communication materials in the pharmaceutical industry. In this heavily-regulated space, the MLR review exists to ensure the materials do not expose pharmaceutical companies to any legal risks. But the MLR review can accomplish even more—it can increase patient trust in the pharmaceutical industry and promote patient autonomy. MLR-approved materials have the potential to enable patients to make fully informed decisions about their health based on comprehensive, accurate, and balanced information.

Different laws and regulations determine how pharmaceutical companies can communicate with patients and caregivers. Regulations vary from country to country, as do the types of materials companies are allowed to share publicly. For instance, the US and New Zealand are the only two countries that allow direct-to-consumer (DTC) advertising of prescription drugs, and it is heavily regulated.1,2

These laws and regulations, coupled with industry codes of practice, like the Pharmaceutical Research and Manufacturers of America PhRMA3, aim to ensure the information provided to patients and caregivers is:

  • Scientifically accurate, not misleading, and based on substantial, sound evidence
  • Aligned with the drug’s approved use, and includes the required warnings and precautions
  • Balanced, so the emphasis given to the benefits of using a drug is similar to the associated risks (such as potential side effects). This is also known as “fair balance.”4

As part of an MLR review, medically- and legally-trained advisers review the materials based on the principles described above. Alongside the advisers, there are many different stakeholders in the MLR review process, including:

  • Marketing teams that champion the process,
  • External agencies and vendors that may produce and revise the materials, and,
  • Patient-communication researchers and experts, who bring in the patient perspective.

The review process itself can take different forms, depending on the material type and the company. It often includes a live review meeting, during which the different stakeholders gather to discuss issues that the MLR advisers point out and suggest potential solutions. Based on the meeting, the marketing and external agency teams revise the materials and resubmit them for additional review cycles until approved.

 
Typical patient communication materials that undergo MLR reviews5,6
  • Prescribing Information (PI), also called product information, product labeling, or the package insert, and summary of product characteristics (SmPC, SPC) in the EU and UK. For healthcare providers who would prescribe the drug. Contains information on the drug’s use, chemical description, mechanism of action, efficacy, and safety. Not meant for a patient audience as is, but the content is often used for developing patient-facing materials.

  • Patient Package Insert (PPI), also called patient product information, or medication guide, and patient information leaflet or package leaflet in the EU and UK. For patients and caregivers. Contains a short summary of the main topics in the prescribing information.

  • Standard Response Documents (SRDs)7, also called Standard Response Letters (SLRs). For internal Medical Information (MI) teams in pharmaceutical companies. Contain responses to unsolicited requests for information about a drug. While MI teams traditionally only respond to requests from healthcare providers, companies are increasingly receiving direct requests from patients and caregivers, so patient-friendly SRDs are on the rise.

  • Branded marketing materials, such as advertisements, brand websites for patients and caregivers, and promotional labeling, e.g., patient brochures. Only available in countries that allow direct-to-consumer advertising. For patients and caregivers. Often contain patient-friendly descriptions of the drug’s mechanism of action, efficacy and clinical study results, safety information, financial support, and information for caregivers.

  • Unbranded marketing materials, such as disease awareness campaigns, also called help-seeking advertisements. For patients and caregivers. Contain information about a disease or condition in order to increase awareness and encourage people with symptoms to talk to their doctor. They do not include information about specific drugs.

 

The MLR review as a collaborative process

The internal MLR review and external health authority approval processes (for example, in the US, the FDA’s Office of Prescription Drug Promotion8) ensure that the public-facing materials published by pharmaceutical companies strictly adhere to regulations. For patients to make informed decisions, this process is essential. Making an informed decision based on partial, biased, or inaccurate information is impossible. But equally essential is ensuring that patients and caregivers can actually understand the information provided, or at least understand enough to discuss treatment options with their healthcare providers. The information should be clear and accessible, so patients can easily use it in decision-making. This is where collaborative approaches come into play.

Returning to our film production analogy, the “best possible scene” in the context of an MLR review would be the creation and approval of materials that are both compliant with regulations and truly meaningful for patients and caregivers. Achieving this outcome requires collaboration and creative problem-solving among the different stakeholders involved in the MLR review process, each of whom brings their own priorities and expertise.

A typical MLR review might uncover particularly challenging issues that require unique solutions. Solutions that often come from productive conversations among all stakeholders. Some of the challenges that can emerge through MLR review:

  • Including risk information that satisfies “fair balance” in a clear and informative way without overwhelming or confusing patients.
  • Finding ways to soften language to ensure claims accurately match the evidence without making the information unclear.
  • Requiring alternatives for scientific terms that are more accurate but may be confusing for patients (for example, the word “protein”, which patients more commonly associate with nutrition than molecular structures).
  • Finding the “simplification sweet spot” of providing enough context to accurately describe a clinical study or mechanism of action without overburdening the reader.

The examples above are only a sample of the types of topics discussed in MLR reviews. They are context-dependent and may require different solutions depending on the format of the materials and health authorities’ requirements.

How service design can enhance the MLR process

In film production, there could be moments in which “creative” tension turns into “not-so-creative” tension. This is the nature of crew members bringing different priorities and perspectives, combined with limited time and external pressures. The same can happen in MLR reviews. Cast in a different light, MLR reviews can be an opportunity to think creatively about the solutions that will benefit patients and caregivers the most. It is important to remember that every stakeholder in the process has the shared goal of helping address the unmet needs of patients and caregivers, supporting them through the challenges of receiving a diagnosis or living with a disease, and providing them with all the information they need to make informed decisions.

Service design is a holistic approach that takes into account a wide range of perspectives and experiences throughout the design process. At Bridgeable, we have identified some best practices based on service design methodologies to enhance the MLR review process and center it around shared goals:

  • Starting early: MLR reviews are usually the last step in material creation, but marketing teams can often bring advisers into the process earlier. MLR advisers can and should be part of the early stages of the design process: brainstorming, discussing early prototypes, and joining generative working sessions. Involving MLR advisers early and often in the process has the benefit of helping identify compliance constraints, or guardrails, early, and gaining support from these important stakeholders in advance of the final review.
  • Bringing in patient insights: Patients and caregivers are the ones that will use these materials, and it is crucial to hear directly from them how the materials can benefit them the most. Service design offers many methodologies for qualitative research that yield meaningful insights to complement more quantitative data, including: in-depth interviews, co-creating solutions, and validating prototypes with patients and caregivers. Having patients’ and caregivers’ insights available for the MLR review can help focus the conversation on the audience’s needs.
  • Having a collaborative mindset: All participants involved in the MLR review can gain advantages by understanding one another’s perspectives and motivations. For example, content creators can embrace the concept of “designing within constraints”, recognizing compliance constraints, or guardrails, are there to protect patients, and thinking about constraints as a way to boost creativity.

Working together to produce a picture-perfect MLR review

Bridgeable has deep and longstanding experience in applying service design methodologies in the context of patient and caregiver communications and MLR reviews. Working with our partners, we lend our expertise in bringing the patient’s perspective to the table and facilitating a meaningful discussion among all stakeholders. We see MLR reviews as a collaborative opportunity to reach solutions and create materials that truly empower patients to make informed decisions about their health.


1. Marwah, Upasana, et al. Prescription Drug Advertising and Promotion Regulations and Enforcement in Select Global Markets. Food and Drug Law Institute. https://www.fdli.org/2017/08/prescription-drug-advertising-promotion-regulations-enforcement-select-global-markets/

2. New Zealand Ministry of Health. Direct-to-Consumer Advertising of Prescription Medicines in New Zealand: Summary of Submissions. 2006. https://www.health.govt.nz/system/files/documents/publications/dtca-summary-submissions.pdf

3. Pharmaceutical Research and Manufacturers of America. Direct to Consumer Advertising Principles. 2018. https://phrma.org/resource-center/Topics/Cost-and-Value/Direct-to-Consumer-Advertising-Principles

4. Code of Federal Regulations. 21 CFR 202.1 — Prescription-drug advertisements.” eCFR https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-202/section-202.1

5. U.S. Food and Drug Administration. Basics of Drug Ads. June 2015. https://www.fda.gov/drugs/prescription-drug-advertising/basics-drug-ads

6. U.S. Food and Drug Administration. Drug Advertising: A Glossary of Terms. January 2020. https://www.fda.gov/drugs/prescription-drug-advertising/drug-advertising-glossary-terms#substantial_evidence

7. Saleh, Monica. Medical Affairs Essentials: Medical Information Team – The Backbone of Medical Affairs. Accreditation Council for Medical Affairs. February 2021. https://www.medicalaffairsspecialist.org/blog/medical-information-teams

8. U.S. Food and Drug Administration. The Office of Prescription Drug Promotion (OPDP). February 2023, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp

 

Assets by upklyak on Freepik
Illustration by Aqil Raharjo, Service Designer


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