Role Call: Legal Reviewers & Risk Management in the MLR Process

Most people in pharma have at least heard of the MLR process, if not played a part in it. But even seasoned pharma professionals will admit that the MLR process is incredibly complex, partly because of the sheer number of key players involved. Each plays their own important role and is reviewing for different reasons. In our new blog series, Role Call, we’re exploring the role each reviewer has in helping create and approve promotional materials—and how technology can help.  

For pharma and life sciences companies, the Medical, Legal, and Regulatory (MLR) review process is crucial to preventing financial and reputational damage from inaccurate, dishonest, non-compliant, or biased claims made in promotional materials. 

The stakes are high, so it’s no wonder MLR review is an “all hands on deck” process. But with so many reviewers involved, who’s responsible for what? 

We recently explored the roles both Medical Reviewers and Regulatory Reviewers have in the world of MLR reviews. Today, we’re shining a light on another key member of the MLR team: the legal reviewer. Here’s what you need to know. 

The Legal Reviewer’s job

The Legal Reviewer serves as the primary safeguard against legal liability and risk exposure in pharmaceutical promotional materials. Their core responsibility centers on identifying and mitigating potential legal risks that could expose the company to litigation, regulatory enforcement actions, or financial penalties. 

Unlike regulatory reviewers who focus on FDA compliance, Legal Reviewers take a broader view, ensuring materials comply with federal and state laws, industry codes of conduct, and legal frameworks that extend beyond pharmaceutical-specific regulations. This includes areas like anti-kickback statutes, fraud and abuse laws, privacy regulations, and FTC regulations for promotional claims.  

With a fine-tooth comb, they review all copy and identify and flag misleading claims for legal defensibility and work to avoid exposing the company to product liability from off-label promotion and false advertising claims. They evaluate whether comparative statements, efficacy claims, or safety assertions could be challenged legally, even if they're medically accurate. 

A significant aspect of their role involves ensuring compliance with healthcare fraud and abuse laws, particularly the Anti-Kickback Statute and Stark Law. Legal Reviewers must scrutinize speaker programs, advisory board arrangements, and key opinion leader (KOL) relationships to ensure these activities provide legitimate value and don't constitute improper inducements to healthcare providers. They evaluate whether consulting fees are fair market value, if educational content is genuinely educational rather than promotional, and whether any arrangement could be perceived as influencing prescribing behavior in violation of federal fraud and abuse statutes.

They’re also a key resource in ensuring intellectual property protection, confirming proper use of things like trademarks, logos, copyrighted materials, third-party references, and images and graphics. 

Outside of reviewing the content of the specific materials themselves, the Legal Reviewer also ensures that all materials comply with licensing agreements, sponsorships or co-marketing contracts, and distribution terms. 

Perhaps most importantly, Legal Reviewers assess the overall legal risk profile of promotional strategies, helping to prevent scenarios that could trigger government investigations, competitor challenges, or class-action lawsuits—risks that extend far beyond traditional regulatory violations.

The Legal Reviewer’s biggest challenges

Like many reviewers in the MLR space, the Legal Reviewer is juggling a lot of priorities and facing unique challenges: 

• Regulatory ambiguity is common. FDA, state, regional, and global regulations don’t always provide Legal Reviewers with black-and-white rules, especially for newer media like social platforms or influencer marketing. This means that legal reviewers must often interpret guidance documents and precedent, which can be subjective. 

• Balancing risk with business objectives can be tricky. Legal Reviewers are obligated to protect the company, while also supporting marketing and commercial teams’ desire for impactful messaging. They must walk a tightrope, as saying no too often can slow down the go-to-market process, but being too lenient can invite legal risk—life sciences companies have paid out over $50 billion in fines since 2000.

• Laws and guidance are always evolving. Regulatory landscapes shift frequently, whether it’s large-scale legislation like Europe’s General Data Protection Regulation (GDPR) or the California Consumer Privacy Act (CCPA), or newly established rules around digital advertising and social media. It can feel like a full-time job to keep up with all the changes, and inadvertently following outdated legal interpretations can lead to compliance failures.  

• Digital channel complexity creates new compliance minefields. Legal Reviewers must review promotional materials across digital channels that didn't exist when most healthcare advertising laws were written. A single campaign might require legal review across websites, social platforms, mobile apps, and email marketing—each with distinct legal frameworks for data privacy, content liability, and advertising compliance.

• Review cycles often have tight timelines. Especially when there’s a product launch or multi-channel campaign, the turnaround time for legal reviews can get compressed. Maintaining attention to detail under time pressure is a major challenge, but missing small legal nuances can lead to major liabilities. 

How AI can help Legal Reviewers

Because AI can quickly digest, summarize, and track large amounts of data, it’s a valuable tool in staying abreast of the latest regulatory changes. AI can analyze thousands of historical enforcement actions, warning letters, and legal precedents to identify risk patterns that human reviewers might miss. For example, when reviewing a claim that a treatment "significantly improves outcomes," AI can immediately identify similar language that has triggered litigation in the past, recent court decisions on such claims, and regulatory precedents—providing Legal Reviewers with comprehensive legal context in seconds rather than hours of manual research.

AI can also review marketing materials for risks like defamation, misrepresentation, or compliance violations. It can also scan for ambiguous language that might lead to legal disputes or penalties.

How Revisto supports Legal Reviewers

Revisto’s AI-powered platform streamlines the MLR review for every key stakeholder with minimal implementation effort and immediate impact. With direct integration with Veeva Vault PromoMats and seamless connection to existing workflow, our solution accelerates time to market for life sciences marketing materials, without sacrificing quality or compliance. 

For Legal Reviewers, Revisto acts as a second set of eyes, ensuring consistency in important details like disclaimers, privacy statements, and terms of use. Because requirements can vary by region and even state, Revisto intelligently manages different legal review standards across multiple jurisdictions, automatically applying the appropriate legal framework based on the target market. 

In addition to ensuring appropriate disclaimers are used, Revisto can check compliance against a wide range of advertising regulations, including guidance from FDA, FTC, and local, regional, and national authorities. This eliminates the risk of applying incorrect legal standards and ensures Legal Reviewers can efficiently manage compliance across diverse regulatory environments without manually tracking varying requirements for each market.

Beyond identifying potential issues, Revisto creates detailed documentation trails that support legal defensibility in case of future challenges. This documentation proves invaluable if the company faces regulatory investigations, competitor challenges, or litigation, as it provides clear evidence of the review process and the reasoning behind decisions made.

For Legal Reviewers, this shift from reactive compliance checking to proactive legal strategy represents a fundamental transformation in their role. Instead of spending time catching basic legal violations, they can focus on complex strategic assessments like evaluating the legal implications of emerging marketing technologies, developing legal frameworks for novel therapeutic areas, or crafting innovative promotional approaches that push creative boundaries. Revisto's AI handles core legal review, freeing Legal Reviewers to provide the high-level legal counsel and strategic risk management that truly requires human expertise and judgment.

Reach out today to schedule a demo and see the power of Revisto for yourself. Then, stay tuned for the next profile in our Role Call series.