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A promotional review committee is tasked with reviewing and approving regulated content before it is used in advertising and promotion. This committee generally has representation from Medical, Legal, and Regulatory and is often referred to as “MLR.” Together, the team plays an important role in the review, advising, and approval of printed, visual, audio, and digital marketing assets that will be disseminated as part of a product’s promotional campaign. Having the right PRC team members is critical to maximizing Commercial’s ability to tell a compelling product story in a compliant manner.
Each member of the committee helps ensure that a pharmaceutical brand is in full compliance with the applicable regulations and corporate guidelines, while working closely with Commercial to ensure objectives are met. Aligning on compliant, commercially viable claims is the shared responsibility of Medical, Legal, and Regulatory, as is identifying supportable alternative claim language when needed.
The best PRC teams work in a collaborative and complementary way, with each function playing a critical but distinct role. Here’s a breakdown:
- Medical Reviewer: A PRC medical representative is typically a professional credentialed with an MD, PharmD, PhD, or other relevant degree.
- This team member is responsible for performing a critical evaluation of all product claims to ensure they are consistent with scientific evidence and medical accuracy. During the review process, the medical reviewer conducts deep investigations into the data and references used to support the marketing claims. Additionally, they assess if the claims and associated images are medically appropriate.
Medical reviewers add critical value by applying clinical and scientific expertise to ensure claims are data-driven, scientifically supportable, and aligned with both compliance standards and commercial objectives.
- This team member is responsible for performing a critical evaluation of all product claims to ensure they are consistent with scientific evidence and medical accuracy. During the review process, the medical reviewer conducts deep investigations into the data and references used to support the marketing claims. Additionally, they assess if the claims and associated images are medically appropriate.
- Legal Reviewer: The legal representative selected for a PRC may have a JD degree or comparable relevant experience in risk assessment.
- The legal reviewer is responsible for identifying and addressing potential legal risks associated with promotional materials. This includes assessing compliance with federal and state laws, as well as industry-specific regulations, with a focus on areas such as trademarks, copyright, fraud and abuse, and anti-kickback statutes.
Their role is critical in reducing liability by ensuring that all content aligns with legal standards and cannot be reasonably misinterpreted in a way that could expose the company to risk.
- The legal reviewer is responsible for identifying and addressing potential legal risks associated with promotional materials. This includes assessing compliance with federal and state laws, as well as industry-specific regulations, with a focus on areas such as trademarks, copyright, fraud and abuse, and anti-kickback statutes.
- Regulatory Reviewer: This individual should ideally hold a degree in the sciences, medicine, healthcare, or have comparable relevant experience.
- The regulatory reviewer confirms that promotional materials are consistent with the FDA-approved labeling and comply with applicable laws, FDA regulations, and guidance. This includes ensuring that claims are not false or misleading, that benefit and risk information is fair and balanced, and that safety content is appropriately placed and prominent.
- The regulatory team also evaluates the overall promotional strategy to identify potential areas of regulatory risk, ensuring that the collective messaging across campaigns remains compliant and aligned with FDA expectations. In addition, the team monitors recent activity from FDA’s Office of Prescription Drug Promotion (OPDP) to inform the review process and guide alignment with current regulatory standards.
While the MLR trifecta is the standard structure for a promotional review committee, the full team of potential contributors is often much larger and consists of multiple partners, from different departments, who must work together. While committee members are charged with the actual review, they work in tight collaboration with marketing and brand managers, coordinators, in-house creatives and outside advertising partners, medical affairs, clinical development and R&D, and other professionals tapped for bringing a product from conception to market.
Canopy Life Sciences: Your Partner in PRC Excellence
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Roles and responsibilities outlined in this article refer to standard operating processes in the United States. For information about processes outside the U.S. and how Canopy can help, please inquire here.
