The mystique of PRC unveiled – what is it and why you need it to assure successful promotional review.
- You have received approval from the regulators.
- You have a dynamic sales force in place.
- They have created amazing, eye-catching promotional pieces to tell everyone how fabulous your product is.
Next stop: Promotional Review Committee
TV ads, social media, influencers, pamphlets and brochures at the doctor’s office, professional seminars, and conferences – these are just some of the ways consumers and healthcare professionals learn about your product. Before any of these can reach their final destination or execution, they must undergo the scrutiny and rigor of the promotional review committee.
What is a Promotional Review Committee (PRC)?
What is a PRC? What do they do? Who’s involved? Why are they needed?
The promotional review committee (PRC) is the gatekeeper of advertising and promotional review, the trifecta needed to assure high quality, compliant, and ultimately commercially successful advertising and promotional materials.
The PRC is a specialized, multi-disciplinary team tasked with reviewing and approving all regulated content prior to it being used. A PRC is made up of Medical, Legal, and Regulatory reviewers. These roles are typically filled by experts from an organization’s medical affairs, legal affairs, and regulatory affairs, and promotional compliance teams. Additionally, representatives from the team(s) that have created the materials requiring review are also included in the PRC. Examples include marketing, training, corporate communications, and sometimes medical affairs.
Roles & Responsibilities of the Medical, Legal, and Regulatory (MLR) Representatives
Why these three areas and what are they reviewing for?
Let’s take a look at how this works.
All Ad/Prom pieces, regardless of audience and execution, must be compliant, which means:
- Show fair balance communicating benefits and risks
- Provide information that is truthful, accurate, and appropriately reflects clinical and safety data
- Are not false, misleading, or go beyond the boundaries of safety and efficacy established by the clinical data collected for the product
As a collective whole, the PRC ensures advertising pieces are non-violative, adhere to the appropriate FDA guidelines and standards, are medically accurate, and legally compliant. The PRC’s goal is to avoid receiving an Untitled Letter or a Warning Letter from FDA.
Individually, they each have their specific scope within Ad/Prom review (please note, this is not an exhaustive summary, but rather the high-level expectations of each respective review):
Medical Review
The medical review ensures all clinical data presented is appropriately reflective of the clinical trials conducted and that the data is neither skewed nor mispresented in any way. All medical and clinical references are reviewed, confirming they are correct and appropriate for the data and information being presented.
Legal Review
The legal review confirms all legal aspects of a piece are covered – copyrights, trademarks, and appropriate language for specific items, such as copay information and opt-outs for email signups. The legal team also reviews potential liability that could result from unintentional misconstruction of the piece’s intent and meaning.
Regulatory Review
The regulatory review evaluates ad pieces to affirm that they are:
- Consistent with FDA approved labeling
- In compliance with the applicable Code of Federal Regulation, FDA guidance and standards, Correspondence with FDA’s Office of Prescription Drug Promotion (OPDP), and best practices
- Not false or misleading
- Represent the trade name/generic name appropriately
- For drugs/biologics: that safety/efficacy claims are supported by substantial evidence and that the overall impression is fair and balanced
PRC: Trifecta of Promotional Review
The PRC provides guidance and direction to the marketing team about compliance, risk, potential reasons certain things in a piece may be considered violative, and reason(s) certain claims may or may not be appropriate to use.
The regulatory team also engages and partners with the team to get the messaging out that the team wants while maintaining compliance and minimizing risks.
Ultimately, through their respective reviews and collective interaction and feedback, the MLR review creates a balance of minimized risk while ensuring compliance for the various Ad/Prom pieces marketing has developed to the best extent possible.
ProPharma: Expert Advertising and Promotional Review Consultants
Whether it’s a simple one page print out, fancy social media page, or a standout TV ad, all advertising and promotional pieces must adhere to the controls and rigors of FDA guidance and standards.
The PRC is the gatekeeper, the trifecta of Medical, Legal, and Regulatory reviewers, and the collaborators helping you get the highest quality advertising and promotional pieces possible. They do this by minimizing risk by ensuring pieces are compliant, meet the rigors of FDA’s standards, and are medically and legally accurate.
Wherever you are in the continuum of the Ad/Prom process – just beginning and don’t know where to start, need to revitalize your Ad/Prom/PRC process, or are looking to develop a rock star PRC review – ProPharma’s industry leading team of advertising and promotional review consultants can help; this is exactly what we do.
ProPharma – The World’s Leading Regulatory Consultancy
