Claims management in the digital age
By James Brown, VP and general manager of commercial content at Veeva Systems.
A day late, and a dollar short – this idiom sums up the position many life sciences companies today are in when it comes to producing and managing promotional content in a compliant manner. Current approaches, such as using a paper-based “brand book” or core claims guide, can’t keep pace with the digital realities facing regulatory departments.
For starters, the volume of promotional content is exploding – pharmaceutical companies spent $4.5 billion on marketing prescription drugs in 2014, up from $3.5 billion in 2012. Further, FDA receives an average of 80,000 promotional material submissions a year! Combine this volume with the growing number and complexity of global digital channels actively used to distribute promotions and it’s clear that life sciences companies are overwhelmed and exposed to an alarmingly large risk of error along with all of the associated regulatory and business consequences.
Patients add more to the mix by demanding a richer, two-way dialogue with companies about the efficacy, heredity, and quality of their products. The easy availability of medical information and ongoing conversation with patients via social media channels put intense pressure on companies to properly disseminate promotional content in a strategic, efficient, and compliant way.
At the same time, the cadence and interactivity of messaging has accelerated dramatically while the process of creating, sharing, and approving vast quantities of content involves many stakeholders, often spread around the world. The explosion in global marketing requires a far greater focus on international brand alignment and the need to improve cost efficiencies with smarter re-use of marketing materials. All these pressures drive marketing teams to develop campaigns in which assets are shared, distributed, and re-purposed to global markets, each with different regulatory requirements.
“When it comes to managing promotional content, it’s a new world – demanding, fast-paced, and patient-focused,” says Eric Newmark, program director, IDC Health Insights. “Not only do life sciences companies have to keep up with patient demands for clear, accurate product information, they must also track the steady stream of developments in clinical research so promotional materials remain current. Managing marketing content efficiently has never been more challenging.”
Cumbersome paper-based processes
Life sciences companies that manage massive amounts of promotional content via manual, paper-based processes are inevitably saddled with widespread inefficiency. Medical, legal, and regulatory review, already a notoriously time-consuming process, is even more cumbersome with paper documents and highly vulnerable to human error. Discrepancies can easily arise when brand teams in many departments on several continents have different versions of a promotional piece.
Research reveals how pervasive this problem is today. The Pharma Letter has reported that over the past six years, the number of warning letters issued by FDA for fraudulent marketing practices grew by 78 percent. In addition, findings from the Veeva 2015 Life Sciences Promotional Content Management Survey, which looked at the impact of changing from paper-based to digital content-management processes, revealed startling levels of inefficiency from creation and review to expiration and withdrawal. More than half (52 percent) of respondents in the study say they use automated processes, but most report they’re missing some, if not all, capabilities that are essential for compliance.
Most of the companies surveyed (88 percent) said their content management function is scattered among many systems and methods, suggesting serious break points in existing processes that breed inefficiency. In fact, respondents said that, on average, they use four different systems for promotional materials management with 31 percent reporting to use between five and 20 systems. With so many separate, disconnected systems, a letter from FDA instructing a company to remove all claims from promotional materials for a given product can create severe delays. And, the price of non-compliance is high – according to the U.S. Department of Justice, drug companies agreed to pay $13 billion between 2009 and 2013 for fraudulent marketing practices. Fines are just one price to pay. This doesn’t include the costs for lost productivity, delays to market, and damaged reputations.
Tracking down claims manually isn’t easy
Confronted by this type of warning, a company’s regulatory department faces the daunting task of quickly finding an improper claim amidst a vast assortment of promotional materials that includes brochures, sales aids, advertisements, web site content, and more. The company must remove the claim and report to regulatory authorities that it has been deleted from the public domain. In some cases, life sciences companies must halt promotional activities until the process is complete.
This task is much more onerous when a company’s assets can’t be efficiently shared because of a paper-based materials management system. With paper, there is no inventory listing every appearance of every claim across promotional materials and therefore no easy way to identify all locations of a specific claim to ensure that each mention is withdrawn quickly. This dilemma is all too common. In fact, most respondents to Veeva’s 2015 survey (81 percent) are unable to report specifically where claims and content are used. To locate and remove a single claim in that situation, a company might have no choice but to pull an entire campaign, which leads to lost promotion time as many multichannel assets are stripped of usable, approved content. This task drains valuable regulatory department resources, too, and slows the review and approval of other promotional materials that aren’t affected by the regulatory warning. According to data compiled from Veeva clients, life sciences companies reduce the potential productivity of their review team by 25 percent due to unnecessary rework.
Regulatory isn’t the only group affected. The medical team must vet replacement claims for accuracy; the legal staff needs to decide on the proper corrective action; and operations must orchestrate the complicated withdrawal and re-approval process.
“Life sciences companies need better capability to rectify errors quickly, in real time, before incorrect data is used in sales, marketing, or medical outreach to customers,” Newmark says. “When time is of the essence, helping departments save time by collaborating simultaneously becomes vital.”
It’s time to take claims management into the digital age.
Time is up – being a day late, unfortunately, is much worse than just being a dollar short in the modern world. A single promotional materials management solution with life sciences-specific functionality for creation and approval, plus an accessible reference and claims library, integrated review and approval workflow, complete audit trail, and easy distribution mechanism that’s built around an enterprise digital asset management system brings everything needed for compliance together.
With an end-to-end solution, companies can quickly search for a claim across assets anywhere in the global digital supply chain so local affiliates can deploy global promotional programs and still comply with regulatory standards. This doesn’t come as a shock to the industry. Almost half (49 percent) of the respondents to the Veeva study conceded that while they don’t have primary systems that provide an end-to-end audit trail, having that capability would improve compliance. Yet, with an end-to-end system, outdated materials or claims can be pulled, revised, and redistributed quickly – mitigating the risk of noncompliance and saving both marketing and regulatory teams the chore of manually searching for every instance of a claim or asset. Overhead costs for the review, rework, and distribution of materials plummet. Indeed, even marginal cost savings across the many stages of the digital supply chain can result in significant savings. Likewise, a digital system frees up regulatory department resources by streamlining approval, re-use, and distribution of materials to global company sites.
It also allows real-time collaboration for faster content development and fewer iterations of an asset as it circulates through review and approval cycles, which ultimately, brings promotional materials to market faster. Content reuse is possible too. In this digital world, repurposing content brings dramatic time and cost savings, plus it helps ensure consistent messaging whether a communication is sent via email from a sales rep, through a digital detail online, or in an advertisement.
Maybe most significantly, an end-to-end promotional materials management system with digitized claims can help solve a persistent, costly problem for regulatory departments − replacing claims that become outdated as new scientific data or regulatory requirements emerge. “Because so much research is being conducted and vital new discoveries occur regularly, an important finding from a clinical trial might be outdated in a short time,” Newmark says. “A digital content management system that allows claims to be updated in real time across multiple promotional materials ensures that stakeholders always see the latest, most accurate information. This isn’t possible with a paper-based system that doesn’t have a fast, easy way to amend or remove claims.”
According to the Veeva study, 100 percent of companies using digital, end-to-end content management systems are satisfied with their ability to adhere to regulatory standards across channels and 88 percent are satisfied with their ability to electronically withdraw outdated content.
In the life sciences industry, there is a lot riding on this issue. Old approaches to managing promotional claims are inefficient at best, risky at worst. The cost of failing to efficiently, accurately manage claims is high – not only from stiff fines but also from commercialization delays. Additionally, life sciences companies are now racing the clock. FDA is requiring that promotional materials be submitted via the Electronic Submissions Gateway beginning May 2017. Companies using paper-based claims inventories face the immense task of transferring their records to the digital, standardized submission forms required by FDA. A next-generation technology with digital claims management across the supply chain would make preparing FDA submissions easier and faster.
“To improve current approaches to promotional claims management, automation and the streamlining of manual processes will be necessary, along with potential organizational changes.” Newmark says. “Regulatory, marketing, and sales teams all need to work together to optimize their current claims management practices … not just for business purposes, but to also ensure they are eliminating any potential risk from a regulatory compliance standpoint.”