A promotional review committee (PRC) is a specialized team that is tasked with reviewing and approving regulated content before it is used in advertising and promotion. The PRC generally has representation from medical, legal, and regulatory and is often referred to as “MLR”. This group plays an important role in the review, advising and approval of the final printed, visual, audio, and digital marketing assets that will be disseminated as part of a product’s promotional campaign. Having the right resources is critical to maximizing commercial’s ability to tell a compelling product story in a compliant manner.
Each member of the committee plays a vital role for ensuring that a pharmaceutical brand is in full compliance with the applicable regulations. Here’s a breakdown of each role:
- Medical – A PRC medical representative is typically a professional credentialed with an MD, PharmD, PhD, or another relevant advanced degree.
- This team member is responsible for performing a critical evaluation of all product claims to ensure that they are consistent with what the FDA requires for both scientific evidence and medical accuracy. During the evaluation process, the medical committee member conducts deep investigations into the data and references used to support the marketing claims of the manufacturer of a device or drug. Additionally, they can assess if the claims and associated images are balanced, misleading, or medically appropriate.
- Since the claims must be rooted in the data/evidence, your medical reviewer is a critical partner as they may be in best position to see supportable claims in the data or compliant claim alternatives to the desired commercial objectives.
- Legal: The legal representative selected for a PRC typically has a JD degree.
- The role of the legal committee member is to advise a pharmaceutical company on the legal risks associated with marketing a product based on how it intersects with compliance requirements dictated by federal laws, state laws, and industry-specific regulatory codes. The legal representative should ideally have a background in trademarks, copyright law, fraud, abuse, and pharmaceutical kickback regulations.
- This role is critical to limit the company’s exposure to liability.
- Regulatory: This individual should ideally hold a degree in the sciences, medicine, or healthcare.
- The PRC’s regulatory member ensures that all materials comply with FDA laws and associated regulations/guidelines for promoting drug products and devices. The regulatory role supporting the broader PRC includes ensuring that benefits and risks are balanced, that safety information has appropriate prominence, and that the material is consistent with the approved use. In addition, the regulatory representative serves as the liaison for promotion related interactions with OPDP or the FDA.
- Their input is critical to any product campaign and their insights on recent FDA actions for both warning and untitled letters can help the team best understand current views from relevant regulatory bodies.
While the MLR trifecta is the standard structure for a promotion review committee, the full team of potential contributors is often much larger and consist of multiple partners from different departments that must work together. While committee members are charged with the actual review, they should always work in tight collaboration with marketing managers, brand managers, in-house creatives, outside advertising agency partners, medical affairs therapeutic area heads, clinical development, R&D, and other professionals tapped for bringing a product from conception to market.