To reduce frustration within a promotional review committee (PRC), the PRC must be a well-oiled machine firing on all cylinders and working at optimum capacity. How does a PRC achieve this? By developing and implementing best practices.
Rock star reviewers are great but having them on your team can only take the PRC so far. A company must identify the key areas that impact their PRC and ensure that a team has the tools, guidance, and direction to be as efficient and effective as possible. Getting the most out of your PRC includes developing, communicating, and implementing best practices for all areas the PRC impacts. This begins by developing a well-designed PRC framework.
How to Optimize Your PRC Process
Best practices for any process include three key components: people, processes, and technology. The PRC process is no different. Let’s take a deeper dive into these components and what’s needed from each to establish best practices and a successful PRC.
Defining Roles & Responsibilities
The trifecta – your rock star Medical, Legal, and Regulatory (MLR) review team.
All the reviewers play key roles in the PRC process. It’s important to define the guidelines and expectations for the reviews and clearly define roles and responsibilities up front. If reviewers understand their roles they can stay on track. This will also help avoid confusion and delays in the review and approval of marketing materials.
In our recent blog, we briefly discussed what each member of the MLR review team is responsible for. In addition, each reviewer’s responsibilities include:
- The Medical Reviewer is in charge of reviewing materials and all references to ensure that both the clinical and medical data and claims accurately reflect not only the product label but also the source materials from a medical/clinical perspective. These reviews are scientifically and clinically oriented and focus on the data to ensure the message is not skewed or misrepresented in any way.
- The Legal Reviewer also reviews materials against the label to ensure there is no off-label promotion. The legal review should also focus on identifying potential issues that raise other legal concerns. Examples of other legal concerns include false or inaccurate claims, Anti-Kickback Statues, product liability concerns, and ensuring copyrights or trademarks are protected.
- The Regulatory Reviewer ensures that any claims in materials accurately and appropriately reflect the regulatory agency-approved label. They evaluate and assess all materials to ensure they are fairly balanced in presenting efficacy and safety information. The regulatory review also focuses on evaluating pieces to affirm:
- They are consistent with FDA-approved labeling
- They are not false or misleading in any way
- They represent trade name/generic name appropriately
- Claims are supported by substantial evidence
- The overall impression is fair and balanced
The Regulatory Reviewer also has guidance and enforcement actions to look for, and in the end, the Regulatory Reviewer is responsible for the submission of materials to FDA’s Office of Prescription Drugs (OPDP), or other regulatory agencies as required by various regulatory regimes.
Having details of each type of review clearly defined in procedures sets the expectations upfront and provides direction for the reviewers. The procedures should also indicate the process for escalation when needed in the event consensus is not achieved during the normal PRC discussions and meetings.
Creating Governance and Process for Your PRC
Procedures, Guidelines, and Processes
Developing clear and comprehensive Standard Operating Procedures (SOPs) and, as needed, Work Instructions (WIs) for all aspects of the PRC is critical to establishing best practices. Having clear, concise procedures and processes provides direction to the PRC and creates efficiency rather than confusion.
Defining roles and responsibilities is only one part of creating the governance needed for setting up a successful PRC. Procedures and processes also need to define and provide direction for other critical aspects in order to create an efficient and effective advertising and promotional review.
Types of Reviews and Timelines
There will be different types of reviews for PRC and your procedures need to reflect how each one will be handled.
Procedures need to define the types of reviews (regular, expedited, regulatory only, medical only, etc.) and the timelines allotted for each review. The types of reviews need to be clearly explained along with the required reviewers (e.g., some approaches do not require the entire MLR for reviews and approvals).
The timelines for each type of review must be provided so each reviewer clearly understands the expectations and can dedicate the appropriate time needed for their respective reviews and approvals.
When to Escalate for Resolution - Preventing the Churn
The procedures should also indicate the process for escalation as needed for those instances where consensus is not achieved during normal PRC discussions and meetings. Having an escalation process clearly defines when and how to escalate for resolution so all reviewers are on the same page. This process should clearly define all details and parts of this escalation process, including:
- Who is responsible for communicating the escalation and how is this communicated (email, phone call, etc.)
- Timeline for sending the communication following the decision that an escalation is needed
- Who is responsible for the review and decision on the escalation
- How the review will be conducted (meeting, email, etc.)
- How to document the review and decision on the escalation
Once Source of Truth: Implementing a Centralized Digital Platform
Having the right technology ensures a smooth review and approval process. This includes transitioning to or utilizing a unified digital platform or a digital asset management system (DAM) designed for the submission, review, and approval of advertising and promotional materials.
Having a digital platform is more efficient and effective than using paper and allows for efficient reviews when all reviewers are not in the same location. Unlike reviews done via paper or email, using a digital platform creates a central repository for all of your Ad/Prom materials. This creates one source of truth, regardless of the status of each piece.
Digital platforms create an archive of your pieces by creating a central repository. This includes reviewers’ comments, decisions, and justifications. This archive becomes your audit trail, capturing all activities throughout the lifecycle of your Ad/Promo pieces.
Your platform should also be scalable and have the ability to grow with your company, allowing for the flexibility to optimize MLR workflows as needed. In most cases, you are able to configure the tool to gain valuable metrics from the platform, enabling your team to understand what is happening during the review process. This insight helps companies determine why they are having multiple rounds of review or provides underlying causes of why reviews are not completed in a reasonable manner.
To add even more efficiency, the platform should also contain a built-in library to manage claims and references as well as the option to support Electronic Comon Technical Document (eCTD) submissions.
In order to accomplish all of these objectives and realize your platform’s the full range of capabilities, it needs to be governed by the appropriate SOPs and WIs that provide the reviewers with detailed steps and instructions for completing their respective tasks.
What’s Working and What’s Not: Key Performance Indicators
To know if your digital platform’s workflows and objectives are executing as intended, it’s important to identify, establish, and track Key Performance Indicators (KPIs). These metrics will serve as a foundational benchmark for measuring progress, efficiency, and overall success of the implementation and ongoing use of the platform.
KPIs provide objective evidence based upon the indicators that are chosen and tracked. KPIs may include the time needed to complete reviews, the rounds of review required to finalize the material, and whether reviewers are providing actionable comments or solution-oriented direction to help move the material in the right direction.
Establishing regular review of KPIs enables organizations to track achievements, identify areas for improvement, and make data-driven decisions to refine strategies and processes further.
ProPharma: Expert Pharmaceutical Advertising & Promotional Review Consultants
Having a successful PRC requires teams to identify establish approaches to optimize the review process. This requires developing strong documentation to define roles and responsibilities, types of reviews, timelines, and escalation processes. Having a centralized digital platform brings everything together creating the one source of truth that is critical for efficient reviews while creating an audit trail for all Ad/Promo pieces. The use of KPIs provides you with the data-driven metrics to evaluate how well your processes are executing and also identifies critical areas that need improvement. All of these work together to create best practices for your PRC reviews and processes. Best practices result in creating a best-in-class PRC. Look beyond the trifecta to make your process the best it can be.
