In January 2006, the FDA released a major revision to the patient package insert guidelines, the first in 25 years. So, what was the impetus? According to the FDA, "Each year, approximately 300,000 preventable adverse events occur in hospitals in this country, many as a result of confusing medical information the new prescription label format provides the most important information about a prescription product in a format that is better understood, more easily accessible and more memorable for physicians. By making these changes, FDA is seeking to reduce the complexity of information on prescription drug labels, making them more useful for physicians and their patients."
In the United States, the FDA is clearly taking a firmer stance on the issue of prescription drug labeling and information, including patient package inserts (PPIs). Likewise, in the EU, the European Medicines Agency (EMEA) has issued stricter guidelines for what it calls patient information leaflets (PILs). Other countries, such as Japan, which has its Japanese Ministry of Health, Labor and Welfare (MHLW), also have rules in place today to proscribe insufficient or misleading package labeling.
Alarmed by the rate of preventable patient complications and, even worse, deaths, the industry is now moving in the right direction. Yes, the regulatory cudgel is most often the impetus for change, but at least change is under way. The consequences of inaction actual loss of human life are too costly.
Pharmaceutical manufacturers generate content on an unprecedented scale. Through a combination of mandated communications requirements (e.g., drug complications) and their own branding language, many large manufacturers generate content that rivals the worlds largest publishing houses. From a communications standpoint, the launch of just one popular drug is more costly and complex than distributing a new novel. Add the further complexity of localized regulations and diverse languages and its easy to see why the industry is now so focused on the issue.
The focus on improving patient safety through better communications is also manifested in the FDAs adoption of a standard for electronic submission of label content. Structured Product Labeling (SPL), based on the non-proprietary extensible mark-up language (XML), is the standard manufacturers must now follow for product labeling information the submitted to the FDA.
But many manufacturers dont realize that following SPL can be its own reward. When properly implemented within a manufacturer, the changes SPL forces also help streamline the process of document creation and re-use and automate other time-consuming aspects of content creation and dissemination. For manufacturers, benefits of standardizing under SPL, with XML at its core, include error reduction (as documents do not need to be re-created), dramatic time and cost savings and faster new product rollouts.
Turning Requirement into Opportunity
Clearly, its possible for a manufacturer to turn a process that seems onerous into a business opportunity. Regardless of whether you see SPL and package insert guidelines as a good thing, its impossible to ignore the ways these requirements can spur more efficient and thorough manufacturer-to-doctor and manufacturer-to-patient communication especially at the individual prescription level. Some manufacturers have actually parlayed compliance-related changes into competitive differentiators that allow them to accelerate the introduction of new drugs into profitable global markets ahead of schedule and, most important, well ahead of competition from other branded drugs and, in the long run, generics.
These forward-thinking manufacturers are increasing their global market shares by going beyond the impetus of SPL or PPL requirements to proactively embed new processes, including translation and localization, into their product information management workflow. Yes, it does take considerable front-end work to re-engineer the process, but the long-term rewards far outweigh the costs, especially in a competitive market where a few months of lost sales can have a tremendous impact on the revenue opportunity for a new drug.
So why doesnt every company treat SPL and PPL mandates as strategic opportunities? As with most new processes and enabling technologies, the key question is whether a company has the knowledge and expertise necessary to recognize and capitalize on the inherent advantages. If the answer is no, the processes will be changed only enough to meet minimum requirements, such as the FDA product submissions requirements. In this case there will be no larger strategic benefits, only incremental costs.
If the answer is "yes, we do recognize the advantages of re-engineering an inefficient process," then the rewards are there for the taking: faster, more efficient product rollouts to lucrative new markets; safer drug dispensing and usage; and a more positive overall brand experience for patients and their physicians.
So how does an enlightened pharmaceutical manufacturer reengineer its documentation approach? The first step is embracing the single-source-of-truth approach, which dictates that all content (labels, PPIs, PILs, marketing and promotional materials, Web sites, knowledge bases, etc.) should originate from a single source, thereby maximizing the opportunity to reuse the best and correct content in multiple delivery channels. Separate from the regulatory requirements, this is a proven method for manufacturers to ensure content consistency across the enterprise, including international operations.
While consistency of content seems obvious, one of the greatest challenges companies in all industries face is the translation and localization of content for non-English-speaking markets. The FDA, for example, does not review or approve patient inserts in languages other than English.
Consequently, the pharmaceutical manufacturer is responsible for the accuracy of the all localized content, including printed material as well as on-line content. This is a tremendous and potentially costly responsibility.
Product information practices can vary and may involve different solutions or approaches depending on the size or capabilities of the company. But every company can benefit from industry-wide best practices now emerging from recent regulations. These best practices include more structured authoring requirements, such as the XML requirement of SPL; streamlined translation and localization workflows that leverage the technologies now available to automate and accelerate the process; and other approaches that improve the global efficiency and accuracy of content creation, management and distribution.
Structured authoring and strict adherence to information architectures, for example, ensure cleaner source language content (e.g., English). You cant expect a translation into Spanish to be accurate (and compliant) if theres a problem at the source. The more disciplined a company is about its content development processes, the more confident it can be that it remains in compliance with regulatory requirements. Moreover, cleaner source information also eliminates contextual ambiguity and increases the likelihood and ease of content reuse across the organization and new geographies.
Reaping the Benefits
The benefits of a single-source approach, as described above, include reduced staffing requirements, stronger regulatory compliance and better overall content quality. But thats just part of the story.
A reengineered single-source approach has benefits that accrue to the top line as well. This is most obvious in the area of globalization and localization where rapid and efficient marketing and new product rollout are critical steps in maximizing profit. According to a 2005 report, The Economics of Innovation and New Technology, "a new drug can be both the first and the best in its product category, but if strong signs of success do not appear within nine months after launch, the drug is likely to be fighting a losing uphill battle thereafter, even in a growing market. Or, at least in pharmaceuticals, you get only one bite at the cherry."
With the goal of maximizing profit, pharmaceutical manufacturers should see SPL and patient packaging requirements as more than regulatory burdens. They must see these initiatives as forcing functions that ultimately equip them to more effectively scale globally. This is becoming increasingly important as foreign regulators also tighten their requirements for localization into appropriate languages. The EU, for example, has adopted an XML-based content standard called product information management (PIM). This is not yet a requirement, but many believe its just a matter of time.
Taking the Next Step
So, if youre a life sciences manufacturer, why wait? Just like theres more to Sarbanes-Oxley than onerous rules, so too is there more to FDA regulatory requirements than burden. In both cases, focusing on the regulations alone can make a business compliant, but it may not make them more competitive. If, on the other hand, the regulations are seen for what they are a red flag that the communication process is inefficient then this can be a business-changing opportunity.
With proven technologies available across multiple industries, theres clearly an opportunity for pharmaceutical manufacturers to use the FDA, EU and other regulations as stepping stones to better, more profitable business practices. To that end, manufacturers should start with the following questions about their current patient information management processes:
- Are my content creation and review processes a help or a hindrance to my product marketing strategy?
- Are poor product information and inconsistency across geographies causing costly product shipping delays? Have I done any analysis?
- Am I achieving maximum velocity with product launches have we delayed rollout because the content is still being developed and localized?
- Are my compliance procedures taking away from or contributing to profitability?
The Last Word
The world may be flattening with respect to global business opportunity, but its certainly not becoming more uniform. Not for those whose job it is to take a drug to market globally and maximize its profit potential before a patent runs out or competitors launch alternatives. When a few hundred thousand dollars or Euros can mean points on a financial spreadsheet, you must explore every advantage, technological or otherwise. Yes, mandates about PIL, PPLs, SPL and many acronyms to come can be a burden, but not if you see the flip side: opportunity.
Yes, opportunity is a possible side-effect of FDA rules about patient information, but only if you commit to taking the full dosage.
Marcel Corstjens & Edouard Demeire & Ira Horowitz, 2005. "New product success in the pharmaceutical industry: how many bites at the cherry?," Economics of Innovation and New Technology, Taylor and Francis Journals, vol. 14(4), pages 319-331, June.
About Idiom Technologies
Idiom Technologies (Waltham, Mass.) was founded in January 1998. Its mission was to fill the need for an enterprise-class software solution that could enable large global enterprises to achieve their globalization objectives. The company introduced WorldServer software later that year to power translation and localization operations. For more information on Idiom Technologies, visit www.idiominc.com.