Making MLR Review and Approval More Efficient and Effective
Life sciences companies in the U.S. paid roughly $6.2 billion to settle False Claims Act violations and off-label promotions in 2021. But the threat of costly fines isn’t the only reason to adopt an efficient, reliable, and digital process for handling medical, legal, and regulatory (MLR) reviews and approvals in 2022. With the increasing competitiveness of the life sciences industry, evidenced by a 60% annual increase in average annual drug approvals, there is the prospect of losing significant new patient revenue in the critical early phase of a drug’s sales cycle if MLR problems delay its marketing.
Regulatory guidance on drug promotion doesn’t tell emerging life sciences companies how to do promotion reviews in a cost- and time-efficient manner. For that, there are tech tools and best practices. The right review and approval process will set a company up to document every step and to publish all needed materials in a timely, compliant fashion. Companies that have optimized their MLR workflows have seen a 57% reduction in review cycle times and a 55% drop in time spent in review meetings. Here are some key steps to take to optimize workflows, enhance internal collaboration, and establish a single source of truth.
MLR needs governance and process
To establish effective and efficient MLR reviews, begin with governance and process. Best practice here, as my colleague Gina Sanders recently outlined, is a framework that has representation from every group involved in your content strategy. Your framework should also define the systems and processes to review and manage the content. You need to understand who needs to be at the table and who ultimately owns the decision around any changes to your process.
As therapies become increasingly tailored, the content that promotes them will need to be very different from the mass-market messaging of the past. You should consider a modular content strategy and a review process flexible enough to manage narrowly targeted content efficiently.
How to staff MLR review teams
Emerging companies have limited budgets for every aspect of their operations, including review and approval. You should think about whether you want to hire full-time employees or begin with an outsourced model.
While your medical reviewer will likely be on staff, it is very common for a young company to turn to a consulting firm for regulatory reviews. Look for one with experience in your therapy, product, or device area and ask about its background in the local, regional, and global markets where you will need to make filings and win approvals. You should also make sure that it is comfortable with using your review platform and that it can scale to meet your needs.
Your legal review team may be outsiders on retainer or billing by the hour. Given the cost of that time, it makes sense to channel legal work through a purpose-built technology solution so that time is not wasted.
“It’s important to recognize that MLR review is a requirement for all life sciences companies,” says Jamie Moccia, manager, MRC and medical operations at argenx. “That said, it’s critical to focus the resources we have to manage the process efficiently for all stakeholders, while ensuring we support the business in all our initiatives compliantly.”
The right technology for a smooth process
Established pharma and biotech companies commonly turn to technology to manage the rapid creation, review, and approval of their content. Emerging companies can benefit from creating a strong content foundation with MLR and digital asset management (DAM) systems.
A dedicated MLR system will move you beyond the cumbersome paper processes of the past and keep reviews flowing even when reviewers are not all at the same location: Documents are held in a central repository that everyone can access, including contracted reviewers and your agencies. A dedicated MLR system should have a built-in library for effectively managing both claims and references. This can cut both the administrative burden around maintaining your claims library and your claim management risk across countries, channels, and assets.
“We need a system that can scale and grow along with our business,” says Martin Boyle, senior director of field and marketing operations at Regeneron. “By using a core technology solution, we have a single source of truth for approved content and the ability to flex and optimize our MLR workflows as the company evolves.”
A strong MLR system should offer the speed and automation to support Electronic Common Technical Document (eCTD) submission to the U.S. Food & Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research. Finally, look for an MLR system with flexible review workflows so that you can meet your organizational needs as you scale.
Using a DAM to scale content development
DAM systems are also foundational to a scalable content development and review process. They organize all the text and graphic elements related to your content and provide an approved library for your agency partners to access and build new content rapidly. DAM systems hold metadata and rights information for every content element and, if an asset is later reused in another channel or content format—a best practice to maximize your content spend—you’ll have full visibility into previous MLR approvals, so you’ll know when it was last vetted.
MLR reviews have always been a critical element of marketing operations at life sciences companies. That will not change, but the days of doing them all on paper, email, or spreadsheets are over. Embracing a purpose-built MLR system now can enable you to better manage the process, make it more efficient and prime it to scale it as your company’s needs grow.
Learn more about making your company’s compliant medical, legal, and regulatory reviews faster.