Optimize the promotional content review process
With the growing emphasis on digital content, digital channels and personalized content, the increasing pace and number of drug approvals, as well as the complexity of claims with drug types, puts pressure on teams. Responsibility for reviewing promotional content has grown, both in terms of content volumes 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 claims per letter in 2020 increased by 30% compared to 2020.
Technology-driven healthcare solutions company Indegene says most pharma executives have recognized that increasing manual review capabilities by adding staff or simply outsourcing staff is not enough to balance these needs. Hence, they make way for investments in AI / ML and technology based solutions that can transform the review process into an automation assisted and technology enabled process.
Here, Sameer Lal, Senior Vice President of Ingene, discusses the need for short-term strategies to decongest the bottlenecks of the manual review process through process optimization and sharing recommendations on how businesses can improve compliance and maintain reasonable time-to-market.
Pharm Exec: What are the reasons for the increase in the number of warning letters from the Office of Promotion of Prescription Drugs to pharmaceutical companies since 2019?
Sameer Lal: There has been a significant increase in the use of digital channels, especially in the last two years since 2019. The amount of content created has just exploded and there has been a significant increase in content aimed at patients. In general, patients would have a very limited understanding of the risk posed by a pharmaceutical product, and therefore any material that does not balance the benefits of the drug with safety could attract further consideration from the FDA. This is why promotional material aimed at patients is attracting much more attention from the FDA.
In what areas do most companies fall under the OPDP?
Much of the OPDP review focuses on patient-targeted content with a potentially false or misleading portrayal of the risks and benefits, the omission of important facts, and the lack of adequate operating instructions. A large number of citations have been made for documents on the Internet which are primarily intended for patients. This is why a rigorous MLR (medical, legal and regulatory) review process is all the more important to anticipate such risks.
What are the challenges for teams reviewing promotional content in a context of continuously increasing digital content, digital channels and personalized content?
The bottom line is that while the amount of content submitted for review to internal MLR teams has increased 3-4 times over the past few years, the size of review teams has not increased by that extent. With a greater emphasis on consent and confidentiality laws (which sometimes differ by geography), reviewers’ accountability for patient-focused content is all the more important. In addition, digital channel content comes with increased variety and formats, including varied data visualization. With the growth of specialty agencies, not everyone is fully familiar with the MLR exam requirements of a specific pharmaceutical company. This leaves reviewers the responsibility of sometimes spending considerable time on basic content hygiene issues with submissions (including job codes, reference labeling, etc.) before they can even begin the review.
How has COVID impacted the creation and review of promotional content?
COVID has accelerated the pace of the digital transformation pharma was undergoing before the pandemic struck. As a result, companies haven’t had a lot of time to put in place processes and systems to create content or speed up review. There was not enough time to learn and apply; instead, changes in working methods had to be made on the go.
In the post-COVID world, companies are increasingly evaluating alternative channels for sales representatives to communicate with healthcare professionals, especially during the pandemic, when in-person meetings are discouraged. Content that can be easily adapted for sharing in web meetings is one example of the impact of the pandemic. Some companies have moved significantly towards omnichannel content that puts the customer at the center and remembers them throughout their journey, allowing them to seamlessly start on one channel and conclude on another based on their preferences and preferences. its conditions. Many changes have been made to the review process due to the pandemic. For example, companies that had live in-person reviews adapted to workflows that allow reviewers to view material offline and then integrate the comments into a single file for the ad agency to take action.
How can current technology make the task more manageable?
There are a number of ways that technology can help make the review process much more efficient. For example, some of the business rules applied above could also be automated to obtain an initial risk profile of the asset, which can then be examined for proper prioritization. For example, a complaints library can be created using an AI-powered solution that can automatically scan and extract complaints from a previously approved item. Subsequently, the following set of content for the same brand can be parsed through an AI / ML engine and parsed against the claims library to validate whether they are existing, approved claims with or without change of. verbiage or completely new claims. Such automation not only allows for initial classification by levels, but can also help reviewers during the actual review, as they can ignore claims that have already been approved. A “content comparator” can examine content items before and after the exam to confirm that all the edits sought have been made, eliminating the need for a second review.
If companies choose to invest in this technology, what other organizational and / or cultural changes do they need to support it?
Change management is at the heart of any technology intervention, especially in such a critical function as the MLR exam. It starts with a shift in mindset to allow confidence in technology to thrive. The technology is like a guide dog that needs time and patience to be properly trained so that their owners with varying abilities can get the most out of their life experiences. Working methods need to be adapted by relying more on systems and processes. A transfer of responsibility to asset owners and agency teams is fundamental to the success of the technology. Ultimately, it all starts with a strong conviction to change the narrative to make the MLR process a more strategic partner to bring pharmaceuticals to market faster and in a compliant manner, reflecting the impact of digital on the industry.