he promotional review committee is a critical function within pharmaceutical companies actively promoting their prescription drug products. Comprised of a core team representing Medical, Legal, and Regulatory professionals, the goal of a review committee is to approve advertising, promotional, and educational materials. This brief review illustrates the principles of promotional review and industry best practices.

What is MLR?

The promotional review committee is a multi-disciplinary group with representatives from Medical, Legal, and Regulatory and is often referred to as “MLR.” Together, as a team, they ensure materials are fair balanced and meet function-specific standards while achieving marketing’s goals. In the US, the Federal Food, Drug, and Cosmetic Act (FD&CA) and Title 21 of the Code of Federal Regulations (CFR) predominantly govern prescription drug advertising and promotion.

Roles of Each Reviewer

• The Medical representative, generally an individual with an MD, PharmD, PhD or other advanced degree, is responsible for critically evaluating material for scientific/medical validity and consistency with the FDA-approved labeling. Data and references used to support claims are also strictly evaluated.
• The Legal representative, typically an attorney with a JD degree, advises on legal risk by broadly reviewing materials for compliance with federal and state laws and industry codes/guidances. Areas of expertise include copyright and trademarks, fraud and abuse, and anti-kickback issues.
• The Regulatory representative ensures that the material complies with all applicable FDA laws and regulations on drug promotion. This individual generally has an advanced degree in the sciences or healthcare and acts as the representative during interactions with the FDA or its Office of Prescription Drug Promotion (OPDP).

In addition to the review committee, other personnel include marketers or project owners, and other content creators such as advertising agency partners. These individuals are generally teamed together based on their audience, with one group dedicated to promoting to consumers and the other to healthcare professionals. Together, they are responsible for developing, submitting, gaining approval, and disseminating final materials for promotional use.

Most promotional review teams also have a review meeting administrator and proofreader. The administrator is generally responsible for coordinating and distributing meeting agendas, facilitating meeting flow, and acting as a centralized resource for those needing assistance with the review process. The primary responsibility of the proofreader or review editor is to assist in the review of materials and ensuring that content is consistent with company policies and style guidelines. This individual can also guarantee that all requested changes were appropriately incorporated into revised material, often times eliminating the need for the MLR committee to review the material again.

Material Types

Traditional promotional pieces include detail aids, direct mailings, and slide decks but marketing tactics are quickly evolving due to the expansion of digital marketing. Websites, videos, eMails, and various components associated with a social media presence are now among the list of items needing review committee approval.

Importance of Compliance

The promotional review team is a critical function because there can be severe and costly consequences if things go wrong. If OPDP finds promotional material to be violative, they can issue corrective action in the forms of an Untitled Letter or a Warning Letter. Per the FDA:

“Untitled letters are used for violations that may not meet the threshold of regulatory significance for a warning letter and request correction of the violations. Unlike a warning letter, an untitled letter does not include a statement that warns the individual or firm that failure to promptly correct the violation may result in enforcement action. FDA generally is under no legal obligation to warn individuals or firms about violations before taking enforcement action.”

More broadly, untitled letters give the pharmaceutical company the opportunity to cease use of the problematic material and take voluntary corrective action. Warning letters are issued for more serious violations and require that the company correct the problem within an allotted timeframe.5 Other government agencies, such as the Office of Inspector General and Department of Justice, can also become involved depending on the violation, and this may result in Corporate Integrity Agreements (CIA) or significant fines.

Tools to Help Promotional Review Teams

Depending on the number of assigned drug products, MLR reviewers may conduct promotional review on a full-time basis or in addition to other responsibilities. Balancing multiple responsibilities with the need to remain compliant make it essential for a review team to remain efficient. Current best practices include:

• Centralized repository for storing promotional pieces. It is important to have an electronic system to track, review, approve, and archive all advertising, promotional and educational materials. Paper-based systems are no longer sufficient now that companies are required to submit promotional materials via the electronic gateway to OPDP. Supporting documents such as references should also accompany each piece.
• Foundational training on this repository and related systems. All team members should receive training so they understand the fundamentals of the system, followed by more detailed role-specific training. If resources allow, create a user handbook and designate more than one superuser (an internal expert on a system) to help triage system-related issues.
• Core claims documents. Prescription drug campaigns and claims will evolve as a brand begins to mature. A core claims document or brand book will keep team members aligned throughout this evolution. This asset can track each claim within the promotional content and can also serve as reference library. To be most useful, the claims document must be meticulously maintained and routinely shared with all content creators and review members. Given their involvement in the promotional review process, a review editor (if available) can assist with the vital task of keeping this document current.
• Submission guidelines. While standard operating procedures (SOPs) outline the general process behind a group or task, a submission guideline or checklist is a more detailed resource. To help prevent repetitive submission errors, MLR teams can create a checklist specifically outlining the steps project owners must completely before submitting their material for review. Examples of reminders can include:
  • Item code and date must appear on the piece
  • All supporting references must be annotated and accessible
  • Quality check has been completed for spelling, grammar, and format.
• Co-creation. Promotional review teams should welcome marketing colleagues and agency partners in co-creating more complex pieces such as videos or materials using new technology. Working together during the concept phase will enable the MLR team to provide guidance prior to a piece being fully developed, avoiding multiple rounds of review, edits, and duplicative costs.
• Keeping current and continuing education. Participating in professional meetings or training courses, especially when held in their traditional in-person format, allow for networking and learning first-hand the practices of other industry colleagues.

Putting It All Together

At times there may be conflict among those involved in the review process, but in the end the core objective is the same – to put forth compelling AND compliant materials. Materials that are compelling but not compliant can prompt OPDP or other government agencies to issue a warning regarding the problematic promotional piece. Open communication, teamwork and adoption of one or all of these best practices will help your promotional review team run successfully while mitigating company risk.

Disclaimer: The views expressed above are solely the author’s and not of her employer.