GenAI Assistant for MLR: a compliant accelerator for MLR/PRC process tasks

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The Medical, Legal, and Regulatory (MLR) and Promotional Review Committee (PRC) processes in the life sciences industry have long been inefficient and time-consuming. This decades-long inefficiency has a new solution: Generative AI (GenAI). According to a February 2024 report by Bain & Company [1], 75% of pharmaceutical companies consider GenAI a top priority at the C-suite and board levels. This blog aims to demystify GenAI, highlight the inefficiencies of the current MLR process, and demonstrate how GenAI can offer a compliant, flexible, and scalable approach to accelerating MLR initiatives.

Why the scrutiny of MLR?

MLR review is a rigorous and time-consuming regulatory process essential for every piece of promotional material used in the pharmaceutical, biotechnology, and medical device industries across North America, Europe, and many other regions. Let us look at how and why the MLR process started.

The formal MLR process in the U.S. began to take shape following the Prescription Drug Marketing Act of 1987 [2]. This legislation emerged in response to growing concerns about pharmaceutical marketing practices, leading to increased oversight and regulation by the U.S. Food and Drug Administration (FDA).

Key MLR milestones

1962: The Kefauver-Harris Amendments [3] to the Federal Food, Drug, and Cosmetic Act required drug manufacturers to provide proof of their drugs’ effectiveness and safety before approval. This marked the beginning of more stringent regulations and oversight of promotional practices.

1980s-1990s: The FDA issued guidelines and regulations that further defined and regulated pharmaceutical advertising and promotional practices. The Prescription Drug Marketing Act of 1987 and the FDA’s 1997 guidance on direct-to-consumer advertising [4] were pivotal in shaping the regulatory landscape.

Early 2000s: The industry began adopting structured processes involving cross-functional teams to review promotional materials for accuracy, compliance, and ethical standards.

Today: The MLR process is a critical component of the pharmaceutical industry’s efforts to promote products responsibly, adhere to regulatory requirements, and maintain public trust.

Is PRC regulated as well?

Regulatory agencies worldwide require the pharmaceutical, biotechnology, and medical device industries to use MLR or PRC review processes to ensure that all promotional and commercial materials are accurate, compliant, and ethical [5].

While the MLR and PRC processes share common goals and involve overlapping participants, the PRC process has a broader scope. It encompasses the overall strategy and final approval of promotional materials. Within this framework, the MLR process plays a crucial regulatory role, specifically focusing on medical, legal, and regulatory compliance.

Similarities between MLR and PRC

Purpose

Both processes are designed to ensure that promotional materials are accurate, comply with regulations, and uphold ethical standards [6].

Participants

Both typically involve cross-functional teams, including representatives from medical, legal, regulatory affairs, and often marketing and compliance departments.

Focus areas

Both review processes concentrate on verifying the accuracy of scientific claims, ensuring compliance with legal and regulatory requirements, and maintaining ethical standards in communications.

The MLR/PRC promotional material review workflow process, expectations, and challenges

Initial draft: The marketing team or agency creates a draft of the promotional material. The content owner reviews the document for spelling and grammar errors before submitting it for initial review. This stage is manual.

Initial review (PRC): A broader team, including members from commercial, public relations, and compliance departments, reviews the draft for strategic alignment and preliminary compliance. This stage also addresses grammar and spelling issues.

Detailed review (MLR): The medical, legal, and regulatory teams conduct a thorough review to ensure scientific accuracy, regulatory compliance, and legal soundness. Although the primary focus is on their areas of expertise, these reviewers also address any missed grammar or spelling errors.

Feedback and revisions: The content owner incorporates feedback from both the PRC and MLR reviews, revising the materials as needed. This often involves multiple rounds of review and revision.

Final approval: The PRC or MLR team provides final approval, ensuring all concerns have been addressed and the material is ready for use. A 2253 submission is sent to FDA to confirm approval to launch assets [7].

Regulatory compliance expectations of the MLR process

Accuracy: Ensures that all information regarding a drug’s efficacy, safety, and side effects is accurate and supported by scientific evidence. This is essential for maintaining credibility and trust with healthcare professionals and patients.

Ethical standards: Upholds ethical marketing practices by preventing the spread of misleading or exaggerated claims about a product. This helps maintain the integrity of the pharmaceutical company and safeguards public health.

Risk management: Identifies and mitigates potential legal and regulatory risks associated with promotional materials. This proactive approach helps prevent future issues and liabilities.

Consistency: Ensures that all communications align with approved messaging and branding guidelines. Consistency is key for building a strong, recognizable brand and providing clear information to stakeholders.

Trust: Assures healthcare professionals, patients, and regulatory bodies that the information presented by pharmaceutical, biotechnology, and medical device/diagnostics companies is reliable and trustworthy.

Legal protection: Helps shield the company from potential lawsuits by ensuring that all claims are substantiated and that risks are properly disclosed.

The use of unapproved promotional materials can lead to significant regulatory, legal, financial, and reputational consequences for pharmaceutical companies. This underscores the industry’s strict adherence to the MLR process.

Having established the importance of the MLR process, let us now address the familiar challenges that BioPharma and medical device companies often face when implementing it.

MLR process challenges

The MLR process presents several challenges that can impact the efficiency and effectiveness of promotional activities.

Firstly, the process is often time-consuming, routinely causing delays in the release of promotional materials. The need for thorough reviews and multiple iterations can slow down marketing efforts, particularly in fast-paced markets or during new product launches.

Additionally, the MLR process is resource intensive. It requires substantial input from dedicated staff across marketing, medical, legal, and regulatory departments. This can be particularly burdensome for smaller companies with limited resources, adding both cost and strain to their operations.

The risk-tolerance impact is another significant challenge. To avoid regulatory issues, MLR teams might adopt an overly conservative approach, which can dilute marketing messages or omit valuable information, reducing the effectiveness of promotional materials.

Coordinating resources between different departments can also be problematic. Conflicting opinions and the need for alignment can lead to inefficiencies and delays, complicating the review process.

Inflexibility is another issue, as the structured nature of the MLR process can impede quick responses to market changes or competitive actions. This rigidity can hinder the ability to adapt promotional strategies or deliver timely educational material to healthcare providers.

Lastly, even with efficient management, the MLR process has the potential to become a bottleneck, especially during high-activity periods such as new product launches or major regulatory changes. This can exacerbate delays and complicate the timely execution of marketing strategies.

The introduction of GenAI into the MLR Process

The MLR process remains vital for pharmaceutical marketing teams to ensure that promotional activities are compliant, ethical, and scientifically accurate. Balancing the need for thorough review with the demands for efficiency and innovation is a key challenge that is now able to be addressed with the introduction of GenAI.

GenAI and Artificial Intelligence (AI) can significantly enhance and support the MLR process by assisting with various aspects while complementing human expertise. Despite these technological advancements, several elements of the MLR process still require human involvement:

Complex judgement

The MLR process demands nuanced judgment and interpretation of regulations, ethical considerations, and scientific data. Human expertise is crucial for making final decisions that consider the broader context, potential implications, and ethical dimensions.

Ethical considerations

Assessing the ethical aspects of promotional materials involves subjective judgment beyond statistical models' capabilities. Ensuring that messaging is not misleading, does not exaggerate benefits, and adequately discloses risks requires human ethical reasoning.

Context interpretation

Human reviewers can understand and assess context in ways statistical models might not fully grasp. This contextual insight is essential for accurate evaluations.

Stakeholder communication

The MLR process often involves discussions and negotiations among various stakeholders, including medical, legal, and regulatory representatives. Effective communication and resolution of differing opinions rely on interpersonal skills and human interaction.

Human expertise + AI = Accelerated compliance in the MLR process

Combining human expertise with advanced AI technology can significantly accelerate and enhance compliance in the MLR process. Here’s how AI can contribute:

GenAI and Natural Language Processing (NLP)
Biopharma can leverage GenAI and NLP to manage large volumes of text efficiently within the MLR process. NLP models can edit documents for spelling and grammar errors, identify non-compliant language or unapproved claims in promotional materials, ensure consistency in messaging across different documents, and summarize key information from lengthy text. This application of AI helps streamline the review process and enhance accuracy.

Automated compliance checking
AI tools play a crucial role in automating the compliance checking of promotional materials. These tools can conduct initial screenings to verify mandatory disclosures and disclaimers, ensure proper formatting and verification of references and citations, and flag potentially misleading or exaggerated claims. By automating these up-front checks, AI helps ensure that materials adhere to regulatory guidelines more efficiently.

AI for content management
AI-integrated content management systems offer significant advantages for handling promotional materials. These systems can track changes and manage document version control effectively, providing real-time feedback on compliance issues. This integration helps maintain organized documentation and ensures ongoing adherence to regulatory requirements throughout the review process [8].

Predictive analytics
Analytics powered by statistical models can analyze data from previous MLR reviews to uncover trends and common issues that lead to rejections or delays. By identifying these patterns, AI can optimize the review process and predict which materials are likely to require extensive revisions. This foresight helps streamline the review process and reduce time-to-market for new promotional materials [9] [10].

AI tools offer the promising potential to reduce the manual workload for content owners and MLR teams, accelerating the time-to-market for new healthcare provider communications.

The ultimate benefit of MLR acceleration for the pharmaceutical, biotechnology, and medical device/diagnostics industry is that they can educate HCPs (Health Care Providers) sooner and impact patients more quickly, leading to improvement in patients’ quality of life in a timelier fashion.

Compliantly accelerate MLR in Veeva PromoMats with GenAI Assistants for MLR

As a premier Veeva partner with the Veeva AI Partnership certification, BASE life science is at the forefront of solving life science business needs with strategic support and integrated technology. With the introduction of Azure’s GPT-4.0 and Google’s Gemini 1.5 PRO Large Language Models, BASE’s GenAI solution solves critical challenges faced in the MLR process.

BASE technology consultants seamlessly embed GenAI into customers’ Veeva Vault PromoMats, a platform for promotional materials compliance and digital asset management [11]. The GenAI exploits existing customer content, such as claims libraries and approved materials, to generate original content based on carefully curated user prompts.

This results in task-specific GenAI Assistants for MLR, directly incorporated into customers’ existing PromoMats. This approach allows life sciences companies to retain control over their data, infrastructure, security protocols, compliance, and proprietary knowledge. By combining AI with human expertise, the GenAI Assistant for MLR enhances efficiency in performing pre-MLR and MLR tasks. While final decision-making remains with humans, these GenAI Assistants help life science employees to:

Optimize MLR resources by automating pre-MLR and quality checks.

Reduce the number of MLR and quality check cycles by up to 50%.

Minimize rejections and reviewer time spent on tasks like spell-checking and grammar correction.

Improve year-over-year return on investment while avoiding costly software licensing fees.
Introduce GenAI at a pace suitable for the organization, solving time-consuming and costly business problems with scalability.

BASE life science is currently installing the following GenAI Assistants for BioPharma and medical device customers, with innovations ongoing:

Translator

Provides multi-language translations.

Grammar/spelling

Checks multi-language spelling and grammar, linked to client-specific brand and acronym dictionaries.

Code compliance

Reviews content against company-defined regulatory and policy documents, such as FDA guidelines and compliance standards.

Tone of voice

Ensures compliance with client language guidelines and annotates sections of text that do not fit with the tone-of-voice typically used for the Brand, in the specific channel, to the target audience.

Annotation pull-through

Verifies that all suggested MLR process changes in text, images, and formatting are reflected in the final edited document prior to 2253 submission.

Medical

Ensures promotional content aligns with approved medical verbiage, assures medical content is well-stated, and recommends improvements via annotations.

Legal

Ensures promotional content aligns with approved legal content, assures legal content is well-stated, and suggests improvements via annotations.

Regulatory

Ensures promotional content aligns with approved regulatory content, assures regulatory content is well-stated, and provides recommendations via annotations.

Claims

Reviews adherence between promotional material content and the related claims source to assure claim is well-stated by recommending improvements to ensure promotional material alignment with approved claims.

This compliant MLR acceleration aligns with BASE life science’s perspective and practice that we create GenAI solutions to help humans. In this case, the GenAI MLR Assistants support the MLR team by alleviating numerous, repetitive, and tedious MLR process tasks.

AI innovator, Pinar Seyhan Demirdag, LinkedIn Learning’s official AI instructor, emphasizes this approach:

“… with GenAI, we are co-creating with algorithms, but Humans remain the SOLE decision-maker.” [12]

As is the case with BASE life science’s GenAI Assistants for MLR – the Assistants are extremely helpful and create efficiencies in time and budget. They support the tedious MLR processes more likely to consume time in the current MLR process, and they free up humans for the critical decisions and actions that get content more expeditiously approved.