Minimizing Risky Business: A New Model to Gain Control Over Unmanaged Promotional Claims

Transcription

1 Minimizing Risky Business: A New Model to Gain Control Over Unmanaged Promotional Claims

2 Introduction Current approaches to managing promotional claims have failed to keep pace with the realities faced by today s life sciences regulatory departments. The growing volume of promotional content, multiplying engagement channels, and increased regulatory scrutiny are exposing companies to heightened regulatory and business risk. Companies are adopting new approaches that enable the creation, review, and approval of individual claims across many promotional materials, communication channels, and regions. Improving the chain of custody for each claim throughout its lifecycle can help companies access, amend, or remove claims quickly and avoid duplicative reviews for already-approved claims. This paper outlines a path towards simplifying control and visibility of individual promotional claims in order to increase operational efficiency while improving compliance amid changing regulations. The burden of unmanaged claims Imagine your worst nightmare as the head of a life sciences company s regulatory department: your company has received a Warning or Untitled Letter from the FDA. You face a daunting task to determine quickly and effectively exactly where that claim lives in a variety of promotional materials, including brochures, patient websites, sales aids, and advertisements. Then you must identify the violative claim, amend the content, and definitively report back to the FDA that the claim has been removed from the public domain. This unwelcome event has become an increasingly unmanageable crisis for many life sciences companies, due to the exponential growth of content volume, the proliferation of communication channels, and the increase in scrutiny from regulatory agencies. Old approaches to managing promotional claims are inefficient at best, and risky at worst. Many companies review and approve promotional pieces in their entirety, no matter how many claims the piece contains. Each new document gets a fresh review, even if many of the claims contained within have already been approved as part of another piece. But when it comes time to find one particular claim, there is no inventory of every appearance of that claim across promotional materials. The result is claims content that resides in a myriad of places, both digitally and on paper, that companies cannot easily track, amend, or remove. Some organizations take another approach, and maintain brand books or core claims guides that enumerate each claim within promotional content. But these assets are often paper-based and become quickly outdated. They may not be searchable, they may not be shareable by all stakeholders, or there may not be an easy way to amend or remove claims. 2

3 Life sciences companies need an integrated, searchable solution to track, review, approve, and remove each promotional claim individually and separately from the promotional documents that contain them. Without such a solution, that enforcement letter could pose a significant disruption to your business, with heavy downstream implications. You may have to pull entire promotional campaigns to locate and remove a single claim, leading to lost promotion time as websites, sales aids, resources, and other multichannel assets are stripped of usable approved content. Your company may also incur significant cost to review, rework, and distribute materials to various channels and regions. Finally, this type of crisis typically monopolizes valuable regulatory department resources, slowing down review and approval of promotional materials for other, unaffected brands. Regulatory and marketing teams aren t the only parts of the organization impacted by regulatory action. Medical teams must vet the accuracy of the new claim, replacing the one deemed violative by the FDA. Legal teams must assess proper corrective action, and operations organizations must orchestrate the whole withdrawal and re-approval process. A new path to claims management There is a business case for a new approach to claims management that goes beyond the need to be prepared for the worst. Life sciences companies are currently missing out on significant upside they could glean from evolving the current piecemeal, paper-based approach to claims management. An end-to-end, searchable solution is not only important for quickly identifying claims to be removed as a result of regulatory action. It can also help quickly amend claims to include new positive scientific data as it becomes available. For instance, life sciences companies would benefit from the capability to update efficacy claims to include the results of a new head-to-head study across multiple promotional materials simultaneously. This can help boost sales while streamlining the workload of the regulatory department. A systematic approach to claims management helps address current pain points regarding the creation, review, approval, and withdrawal of promotional claims. It can help reduce time to market for promotional materials by streamlining the process for re-use and distribution of claims within new promotional materials. This would ultimately free up regulatory department resources by reducing the need to re-evaluate every claim in a new piece of promotional material, for claims already approved elsewhere. An end-to-end solution that relies on a single source of truth, accessed by all stakeholders, also unifies messaging throughout the organization, reducing discrepancies and increasing efficiency. Your brand teams may span several different departments and multiple continents. A solution that allows every team member to access and deploy identical claims across channels and regions can help bridge siloes within your organization. Message consistency may also result in greater retention by health care professionals or consumers. Another weakness of today s claims management processes is that they fail to leverage the accelerating transformation to digital submission of promotional claims. By May 5, 2017, life sciences companies are required to submit promotional materials via the Electronic Submissions Gateway. Companies using paper-based claims inventories will have a big job ahead to mesh these resources with the digital, standardized submission forms required by the U.S. Food and Drug Administration (FDA). A next generation claims management solution would help ease this transition and speed the process of preparing submissions for the FDA. 3

4 By May 5, 2017, life sciences companies are required to submit promotional materials via the Electronic Submissions Gateway. Why the time is now for a new approach The FDA currently receives 80,000 promotional material submissions per year, and that number continues to climb along with the life sciences industry s burgeoning advertising budgets. In 2012, $24 billion was spent on promoting drugs to health care professionals, according to research by the Pew Charitable Trust. And in 2014, the industry spent $4.5 billion marketing prescription drugs to consumers, up from $3.5 billion in 2012, according to research by Kantar Media. Current promotional claims management practices simply aren t keeping pace with the volume of new content. Meanwhile, regulatory scrutiny over the life sciences industry is increasing to keep up with the volume of promotional materials. The number of overall Warning Letters issued by the FDA grew by 78 percent over the past six years, The Pharma Letter recently reported. The number of letters is expected to rise again in 2015, according to their research. While the number of enforcement letters sent by the Office of Prescription Drug Promotion (OPDP) is just a small subset of this whole, recent settlements show that even a handful of enforcement actions each year can result in significant costs to the life sciences industry. Drug firms have agreed to pay $13 billion between 2009 and 2013 for fraudulent marketing practices, according to the U.S. Department of Justice. Settlements aren t the only costs associated with enforcement actions. In some cases, life sciences firms must halt promotional activities for a given product while allegedly fraudulent claims are reviewed, updated, or removed. Failure to quickly identify each instance of the violative claim throughout all promotional materials and channels could slow down a return to promotional activities or result in further enforcement action. While no company expects to receive an enforcement letter, the reality is that 10 life sciences companies received these letters from OPDP in Allegations included omission and/or minimization of risk (seven letters), omission of facts (six letters), unsubstantiated superiority (three letters), unsubstantiated claims (two letters), and overstatement of efficacy (two letters). The communication channels in the crosshairs of the FDA included sales aids, sponsored links on Google, Facebook pages, product websites, professional telephone scripts, , print advertisements, and educational flashcards. Here are three examples of allegedly violative claims from the 2014 OPDP enforcement letters, illustrating the complexity of tracking and removing claims: Unsubstantiated Superiority Claims A drugmaker was instructed to remove all claims from promotional materials stating that its cholesteral drug was more effective than its rivals, because OPDP concluded the references provided did not meet the standard it set for head-to-head studies. 4

5 Misleading Images OPDP alleged that an image of an hourglass on its side, with a cancer patient and child inside of it, misleadingly led consumers to believe that a cancer drug could stop time for cancer patients. Claims embedded in images, charts, or other visual representations can be especially difficult for life sciences companies to track without a system to catalog, inventory, or tag them. Omission of Risk Information The maker of a weight loss drug received an enforcement letter stating that in its efficacy claims on the product webpage, the company failed to include all of the contraindications and adverse reactions associated with its use. The company would need to add that risk information not only to the product webpage, but also to any other mentions of efficacy across promotional materials. How to prepare for a transition Existing strategies to manage the growing raft of highly regulated content include brand books and other paper-based claims inventories that are inefficient, quickly outdated, and lead to discrepancies. These paper assets also cannot easily be shared, updated, and corrected by internal and external stakeholders worldwide. With no single source of truth reflecting the most updated claims, discrepancies are commonplace. In order to transform what may be an unwieldy, incomplete, and static paper-based approach into a truly integrated solution for creating, reviewing, approving, and ultimately retiring claims, companies will need to take a hard look at necessary organizational and process changes. Organizations should answer the following questions: Current Approach Do you currently manage individual claims? Do you use a brand book or core claims guide? If so, is it on paper or online? How is it maintained and by whom? Do internal and external stakeholders, such as agencies, have simultaneous access to the most updated content? The number of overall Warning Letters issued by the FDA grew by 78 percent over the past six years. 5

6 Updating and Maintaining Claims Does the core claims guide or brand book allow you to see where claims reside within approved promotional content in the public domain? How are claims approved and updated? What level of evidence is needed to support a claim? How will you manage variations in claims across audiences (i.e. payer, consumer, HCP, etc.)? How do you retire an outdated claim? How do you keep track of images or other visual representations that may have embedded claims? Whether your organization is using a paper-based approach, or a disjointed online system that does not allow claims to be simultaneously accessed, a comprehensive claims management solution could benefit your business. An end-toend solution to help steward the company s promotional materials throughout their lifecycle can help companies avoid unnecessary regulatory risk, improve efficiency and speed to market for promotional materials, and help quickly leverage new positive data to bolster existing promotional campaigns. Investing in capabilities that matter Companies should give thought to what new capabilities they require to effectively manage claims throughout their lifecycle, from creation to expiry, across promotional materials and channels. While some of these capabilities may exist in manual form in your organization, automating and bringing these functions together can create operational efficiencies while tamping down regulatory risks. Once companies have identified their assets and deficiencies they can move forward on a path to transform their claims management practices. One important step in the journey is to identify which new capabilities can help the business gain greater visibility into where claims reside and greater control of those claims throughout their lifecycle. There are three major capabilities that form the backbone of an integrated claims management system. They include, first, a central digital asset library for the housing of individual claims as well as assets such as references, clinical study reports, source artwork, and approved content. A new systemic approach to managing claims would also need to include a standardized review and approval workflow, and automated content distribution and withdrawal capabilities. An end-to-end solution that helps stewards promotional materials throughout their lifecycle can help companies avoid unnecessary regulatory risk. 6

7 This is where technology comes in. Here is a list of automated capabilities that can help transform promotional claims management processes: Digital Asset Library Claims Library Access claims via a library that enables users to easily visualize claims and their status. Claim Search Search for claims within document text for a particular promotional document, or throughout the system as a whole to find every use of the claim in an instant. Review and Approval Workflow Claim Creation and Approval Create claims as individual pieces of content. Link associated references, product information, and other support, such as context and claim variations for different audiences. Individual claims then move through the review and approval workflow as stand-alone approved content. Claim Association Automatically associate claims with any document containing it. Tag claims as an object or as an additional reference source, so the claim is linked to each promotional document containing it throughout the entire content lifecycle. Audit Trail Gain visibility into the history of all activities concerning a particular claim. Distribution and Withdrawal Distribution Simultaneously disseminate updates to claims across channels and regions. Withdrawal Quickly remove content from each location in the public domain. Claim Obsoletion Retire content containing an outdated claim with one step to withdraw the content from the market. These capabilities will continue to evolve as the life sciences industry advances towards a new understanding of claims management best practices. Conclusion Next-generation promotional claims management will require organizational changes, new processes, and new technology to automate functions that were previously performed manually, or not at all. Regulatory, marketing, and sales teams must engage in conversations about how current claims management practices fail to optimize your business and may in fact be leaving the company open to unnecessary regulatory risk. Then it s time to act. First, identify inadequate processes and organizational structures. Then make a wish list of capabilities to help evolve from paper or disjointed online system. Finally, bring in technology to operationalize your new claims management approach. The result will be greater confidence in your regulatory compliance efforts, operational efficiency, and harmony of message as all stakeholders adhere to a single source of truth. 7

8 Learn more about improving promotional content compliance at: veeva.com/promomats About Veeva Systems Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 300 customers, ranging from the world s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices in Europe, Asia, and Latin America. For more information, visit Veeva Systems 4280 Hacienda Drive Pleasanton, CA info@veeva.com veeva.com 8