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With the rising emphasis on digital content, digital channels, and personalized content, increasing pace and number of drug approvals, as well as the complexity of claims with drug types, the pressure on teams reviewing promotional content has increased, both in terms of volumes of content and complexity.
In 2020, the Office of Prescription Drug Promotion (OPDP) issued 25% more warning letters than in 2019. In addition, the average number of allegations per letter in 2020 increased by 30% when compared with 2020.
According to technology-led healthcare solutions company Indegene, most pharma leaders have recognized that scaling up manual review capabilities by headcount addition or purely outsourcing staff is not sufficient for balancing these needs. Hence, they are making way for investments in AI/ML-based and technology-based solutions that can transform the review process into an automation-assisted and technology-enabled one.
Here, Sameer Lal, Senior Vice President of Indegene, discusses the need for a near-term strategies to decongest bottlenecks of the manual review process through process optimization and shares recommendations on how companies can improve compliance and maintain reasonable go-to-market timelines.
Pharm Exec: What are the reasons behind the increase in Office of Prescription Drug Promotion warning letters to pharma companies since 2019?
Sameer Lal: There has been a significant rise in use of digital channels especially in the last couple of years since 2019. The amount of content being created has just exploded, and there has been a significant increase in content targeted at patients. In general, patients would have a much-limited understanding of risk that a pharma product poses and hence, any material that does not balance the benefits of drug with safety might draw greater scrutiny from FDA. This is why promotional material targeted at patients draws much more significant attention from FDA.
In which areas are most companies falling foul of the OPDP?
Much of the OPDP scrutiny is geared towards patient-targeted content with potentially false or misleading representation of risks and benefits, omission of material facts, and lack of adequate instructions for use. A large number of citations have been made for internet-based materials that are primarily patient-directed. That’s why a rigorous MLR (medical, legal and regulatory) review process is all the more important to preempt such risks.
What are the challenges for teams reviewing promotional content amid the ongoing increase of digital content, digital channels, and personalized content?
The bottom line is that even as the amount of content being submitted for review to internal MLR teams has grown 3–4 times in the past few years, the size of the review teams has not increased anywhere close to that extent. With greater focus on consent and privacy laws (that sometimes differ by geography), the onus on reviewers for patient-focused content is that much more. In addition, content from digital channels comes with increased variety and formats including varied visualization of the data. With the growth in specialized agencies, not everyone is fully versed in the requirements for the MLR review of a specific pharma company. That leaves the onus on the reviewers to sometimes spend considerable time on basic content hygiene issues with submissions (including job-codes, reference tagging etc.) before they can even begin the review.
How has COVID impacted the creation and review of promotional content?
COVID accelerated the pace of digital transformation that pharma was undergoing before the pandemic hit. Hence companies did not get much time to set up processes and systems to create content or to ramp up review. There wasn’t enough time to learn and apply; instead changes to the ways-of-working had to be made on-the-go.
In the post-COVID world, companies are increasingly evaluating alternative channels for sales representatives to communicate with HCPs, particularly during the pandemic, when in-person meetings are discouraged. Content that can be easily adapted for sharing over web meetings is an example of the impact of the pandemic. A huge shift has been made by some companies towards omnichannel content which puts the customer at the center and remembers them through their entire journey, allowing them to seamlessly start on one channel and conclude on another based on their preferences on and terms. There have been numerous changes made to the review process due to the pandemic. For example, companies that had live in-person reviews have adapted to workflows that allow reviewers to view material offline and then integrate comments into one file for the creative agency to action.
How can current technology make the task more manageable?
There are multiple ways that technology can help to make the review process much more efficient. For example, some of the business rules applied above could also be automated to get an initial risk profile of the asset, which can then be reviewed for correct tiering. For example, a claims library can be created using an AI-based solution that can automatically scan and extract claims from a previously approved piece. Subsequently the next set of content for the same brand can be scanned through an AI/ML engine and parsed against the claims library to validate if they are existing, approved claims with or without verbiage change or completely new claims. Such automation not only enables an initial tiering classification but can also help reviewers during the actual review as they can skip claims that have previously been approved. A “content comparator” can review pieces of content before and after review to confirm all changes sought have been made thereby eliminating the need for a second review altogether.
If companies choose to invest in this technology, what other organizational and/or cultural changes do they need to support it?
Managing change is central to any technology intervention especially in such a critical function as MLR review. It starts with change in mindset to allow trust in the technology to foster. The technology is akin to a guide dog that needs time and patience to be trained well in order to allow their differently abled owners to get the most out of life-experiences. Ways of working need to be adapted with higher reliance on systems and processes. A shift of accountability to asset owners and agency teams is fundamental to the success of technology. Ultimately it all starts with a strong conviction to change the narrative to make the MLR process become a more strategic partner for getting pharmaceutical products to the market faster and in a compliant manner reflecting the impact of digital on the industry.