Three Factors to Consider When Evaluating Alternative Regulatory and Medical Review Options
By Tracy Rockney Co-Founder, OneSource Regulatory
As a leader in a life sciences company that participates in the Regulatory or Medical review of promotional materials (PRC, MLR, MRL or ad/promo review), you need to be prepared to manage a variable workflow. Things like new product launches, safety labeling updates, responses to competitor activities, not to mention staff absences and lack of available, highly qualified resources are always increasing demands.
Unfortunately, these constraints don’t always justify requests for new full-time staff. Oftentimes, the crunch is already underway and it’s too late to hire anyway. So how can you find staff with the right experience, when you need it, for as much or as little time as you need?
Regulatory and medical review revisited
One approach to relieving some of the pressures of the Regulatory and Medical review part of the PRC process is to seek alternative review options, like outsourcing. Connecting with experts outside your own organization and letting them handle review responsibilities lets your current team focus their time and effort on other, more pressing areas.
If freeing up your team for more essential tasks sounds like something you could benefit from, here are 3 factors to consider as you evaluate alternative regulatory and medical ad/promo review options.
Factor #1: Level of expertise required
Your business cannot afford Regulatory or Medical PRC review team members who don’t have the relevant experience to solve your complex problems. The compliance and business costs are too high. Today’s life sciences advertising and promotions regulatory and medical review experts must be well-versed in consumer, healthcare provider, managed care, FDA, and FTC promotional and advertising regulations.
Regulatory and Medical expertise is not one-size-fits-all
You must also factor in the type of skills your particular projects require. Even a highly qualified MRL team member may not be the right fit for all projects. For example, organizations often think they can repurpose staff who have supported FDA filing and approval to support a commercial launch. That’s not always the case. Supporting a commercial launch requires a different skill set and level of expertise.
Questions to ask yourself
- Do you need Regulatory, Medical, or Regulatory and Medical reviewers?
- Do you need staff with deep or varied industry experience?
- Do you need someone with a proven ability to effectively contribute to review meetings?
- Do you need reviewers who can work collaboratively with cross-functional teams?
Don’t forget to factor in familiarity with your PRC review software and standard review operating procedures and policies. Prior knowledge of these significantly cuts down onboarding time. If you don’t already have promotional review software to support your MLR process, there are a number of organizations that can help guide you in the selection process.
Factor #2: Brand type and organization makeup
Where a brand is in its lifecycle and how your company is structured can dictate how best to achieve strategic goals. Whether you’re preparing for a top-tier launch or setting up a product for continued success and compliance, it’s important to account for these aspects when deciding how best to deploy internal or external ad/promo review resources.
When launching a brand, an experienced Regulatory and Medical Advertising & Promotion professional should be assigned to the compound 12–18 months prior to your application’s approval by the FDA. This person should have prior product launch experience and should be able to handle all pre-launch and launch activities.
For growth brands, increased efficiency in the PRC review process results in reduced escalations and fewer marketing revisions, thus saving time, effort and costs for your organization.
Often neglected as resources are focused on launching new products or providing support to growth brands, established brands also benefit from added expertise and efficiencies in the MLR review process.
If you’re in a large company, chances are you have established processes, training, and business requirements that will make augmenting your existing MLR team a better choice.
If you’re in a smaller company, adding full-function support by outsourcing the full PRC regulatory and/or medical review function allows you to assemble a panel of experts to assist your organization with complex promotional issues while maintaining your agility.
Questions to ask yourself
- Will you need someone who is able to work with limited resources?
- Will you need someone who can work the angles in a big matrix system?
Factor #3: Timing
A big advantage of outsourcing a portion of your PRC review process is the ability to access and use expert resources only when you need them. Consider the time required to launch a new product, as illustrated in the graphic below.
Staffing for Variable Hours
Our experience shows that the PRC workflow for supporting a new product launch is ideal for outsourcing. Effort ramps up to approximately 40 hours per week the three months around your product approval. Demand, however is only about 10–20 hours per week in the 12 months prior. Post-launch, support ramps down to a steady state of 5–20 hours per week per product, with peaks based on key market events, like product safety labeling update, response to competitor activity, etc. (Estimates may vary depending on the planned commercial campaign elements.)
Questions to ask yourself
- Are you looking for support for short-term peaks in workload or to fill long-term staffing needs?
- Are you looking for individuals who are able to handle a heavy time requirement?
Transforming the review process
Outsourcing Regulatory and Medical MRL review has become a core strategy to support day-to-day business in the life sciences industry. This new and innovative mindset requires companies to operate in a different manner than they are accustomed to, but when properly executed, it can have a defining impact.
By outsourcing MRL capabilities, companies can tap into and leverage national and international resources with world-class capabilities that aren’t often available internally, while delivering significant time and cost savings. This allows organizations to focus on other important purposes, like successfully commercializing their next life-changing product.
If you’d like to leverage external medical and regulatory resources to support your promotional review process, contact OneSource Regulatory at firstname.lastname@example.org
Meet the Author
Tracy Rockney, JD is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. She is the co-founder of OneSource Regulatory, a technology-enabled regulatory consulting company specializing in regulatory and medical, advertising and promotion review, drug product labeling, regulatory CMC, and commercial compliance.