Massive challenges face Pharmaceutical Executives, directors, senior management and compliance personnel at large cap pharmaceutical companies who, by the nature of their respective positions, have responsibility for the oversight of the hundreds—if not thousands—of sales representatives engaged in marketing efforts throughout the United States. Given the highly regulated nature of the drug industry and the challenges faced in overseeing a sizeable sales force dispersed across the country and offering a wide range of products, your companies have designed and implemented compliance programs intended to:

  • educate your sales representatives about the legal and ethical requirements governing their sales practices; 
  • monitor and audit their actions; and 
  • address any deficiencies that could trigger civil and criminal liabilities and harm to your company’s reputation. 

While overseeing such a program can be daunting, the digital transformation that is revolutionizing business practices can help ensure your compliance program stays strong in the course of the increasing number of regulations, efficiently onboards new sales representatives and empowers your employees to perform their duties in an efficient and ethical manner.

Modernizing Your Existing Compliance Program

Today, pharmaceutical companies are applying artificial intelligence in their research & development efforts to discover new drugs, aid in the administration of clinical trials and improve their supply chain. To further their patient engagement activities, they are turning to digital communications that disseminate educational materials and wellness advice. Yet for most large cap pharmaceutical companies, compliance oversight remains dependent upon time-consuming processes and manual reporting systems. The challenge is complicated further by the need to develop informative and engaging training programs for the sale force, produce reports for the board of directors and senior management, monitor and audit interactions with healthcare professionals, and when necessary, investigate and remedy violations of law.  Overlaid on this, is the need to coordinate the compliance function across your company’s legal, human resources, sales & marketing and IT departments. Some of the major solutions that can aid in this digital transformation effort include knowledge management softwares, content management and workflow tools, and other technologies that manage and optimize the oversight and regulation process in a trackable and repeatable way.

Why Focus Resources on My Company’s Compliance Program

Most pharmaceutical companies that market their products in the United States have some portion of their sales paid for by a federal health care program such as Medicare, Medicaid or the Department of Veterans Affairs. KFF, a non-profit organization focused on U.S. health issues, estimates that in 2017 total U.S. retail prescription drug spending was $333 billion, of which Medicare represented 30% and Medicaid accounted for an additional 10%. Because taxpayer dollars fund these programs, the sales practices employed are subject to standards imposed under various federal and state laws. Violations of these laws are punishable by imprisonment, fines and exclusion from future participation in federal healthcare programs.

These are not theoretical concepts—each year the FBI, the U.S. Department of Justice and the Department of Health and Human Services, Office of Inspector General bring significant law enforcement actions based on alleged violations of the False Claims Act, the Anti-Kickback Act and the Food, Drug and Cosmetic Act. In 2019 alone the DOJ obtained recoveries of approximately $2.6 billion from companies in the health care sector. Thus, it is critical to have in place a compliance program that leverages digital technologies to ensure compliance with these important obligations.

Dangers of failing to initiate effective compliance and Business Transformation 

The Office of the Inspector General of the Department of Health and Human Resources has published guidance for pharmaceutical manufacturers in which it sets forth its general views on the value and fundamental principles of compliance programs. At the outset of its guidance the OIG notes that for a compliance program to be effective, it must have the support and commitment of senior management and the company’s governing body. In fact, there are seven specific instances in the OIG’s guidance where it strongly encourages the participation and involvement of the board of directors and members of senior management. This focus on the “tone-at-the-top” makes clear the importance that the OIG places on a strong and explicit commitment by a pharmaceutical manufacturer’s senior leadership to foster a culture that promotes compliance with applicable federal health care program requirements when engaging in sales promotions of their drugs. In today’s increasingly digital world, that commitment should extend to modernizing your company’s compliance program.

Where Can Digital Transformation Help

Using digital transformation to modernize your compliance program means optimizing business processes using technology to streamline operations, improve efficiency, automate repetitive tasks and more proactively engage with your sales force.  Employee onboarding, sales training, product launch monitoring and marketing content approval are among the areas that will benefit from automated workflows and more timely execution. Here are some meaningful ways in which your company can put digital transformation to work today:

Signal Top Management’s Commitment to Compliance with Video Messaging

A senior executive’s commitment to compliance can go a long way towards boosting a culture of compliance among your sales force. While this level of support is powerful, your executives are busy with a myriad of responsibilities. Combining video with a powerful technology to manage the complexities of strategy, creation, and delivery of content , however, means you can extend the presence of your senior executives and deliver a personalized interaction to all your sales representatives—whether as part of the onboarding process for new hires or at regional gatherings of more seasoned employees. Using digital transformation in this manner will also serve as evidence to law enforcement officials of senior leaderships’ commitment to compliance should the need to do so ever arise.

Modify and Update Educational and Training Materials in Near-Real Time

Producing and distributing educational and training materials that inform sales representatives about the legal policies applicable to their roles is one of the most important components of a successful compliance program. Typically, employees need to be educated on the basic elements of the False Claims Act, the Anti-Kickback Act, the Food, Drug and Cosmetics Act and comparable state laws. Oftentimes the material will include information on new drugs and the indications for which the Food and Drug Administration has approved their usage. It may also address new regulations issued by federal health care programs applicable to drug sales. As the regulatory environment is constantly evolving, it is imperative that people calling on health care professionals have the most current information readily available. 

By building a Content Encyclopedia®, a frictionless structure for your organization to operate within, you can create tutorials on key subjects that your sales representatives may review at times and from locations that do not interfere with their sales duties. This will permit individuals to learn at the speed most appropriate to their skills, experience and knowledge. It will also enable sales reps to “refresh” their understanding of complex topics. This process also has the benefit of enabling your company to electronically generate a record of the time devoted by each salesperson to educational activities, a description of the training sessions and copies of materials used. Finally, you can design a system that tests the knowledge of your sales representatives on various important subjects, a further demonstration of the seriousness with which you and they engage in compliance activities. All these benefits are particularly helpful when onboarding a new sales rep so your company can be confident the person has been properly indoctrinated with your company’s approach to compliance matters.

Create a Single Source of Truth for Your Sales Force

One of the major challenges faced by large cap pharmaceutical manufacturers with hundreds—potentially thousands — of sales reps dispersed across the United States is the need to ensure they are using the right marketing materials when making sales calls on health care professionals. Managing a vast portfolio of content makes it difficult to know what needs to be updated and refreshed. Rather than rely on hardcopy materials that require modifications to be made, printed and distributed to a widely dispersed sales force, digital versions can be rapidly updated and transmitted in near-real time. Additional substantial impact can be achieved by exploring the use of technologies that can enable your sales reps to review information on their smartphones or tablets with confidence that it is current and cleared for use in the field. Having a single source of truth for all topics relevant to your sales force will result in fast, accurate and consistent answers that can be delivered in any media format—video, slide presentations and text. Plus, the speed, efficiency, and higher quality content delivered will built trust and confidence in your sales team and impress your customers. 

Bring Subject Matter Experts Along on Sales Calls

Your sales representatives need to be truthful when meeting with health care professionals and present information about your drugs’ efficacy and risks in a balance manner. With the increasing use of biosimilars, the level of sophistication required to explain how a drug treats a medical condition is rising. Digital transformation softwares can extend the reach and influence of your subject matter experts. Expanding the digital presence of your best SMEs means they can answer customer questions and empower other representatives to become more knowledgeable about the drugs they are marketing.

Use Data Analytics to Monitor “Off-Label” Promotion Activities 

The U.S. Department of Justice has publicly warned pharmaceutical manufacturers of the need to monitor the interactions of sales representatives with health care professionals to identify potential unlawful actions. Paying kickbacks to physicians to prescribe drugs for off-label use, compensating physicians to give promotional lectures supporting off-label use of drugs and underwriting travel expenses of health care professionals to resort locations to listen to promotions about off-label use of drugs are some of the items that should be subject to heightened scrutiny. Today, monitoring and auditing expenditures often requires manual data extraction from multiple systems covering emails, reimbursement expense forms and sales reports. Digital transformation can streamline this important function by utilizing algorithms to mine email text for potential “red flags.” Moving the submission of expense and sales reports online results in more timely and searchable data that will improve the timeliness and transparency of your data collection efforts. The ability to automatically identify payments above a specified level to one or more health care providers or reimbursement claims for travel expenses above a pre-set level will minimize repetitive and boring tasks, thereby freeing up valuable resources in the compliance function that can be redirected to higher-value activities.  

Create an Internal Audit Trail to Ensure Drug Promotional Labeling and Advertising Comply with Food, Drug, and Cosmetic Act Requirements

To satisfy requirements under the Food, Drug, and Cosmetic Act, prescription drug promotional labeling and advertising must:

  • be truthful and non-misleading;
  • convey information about the drug’s efficacy and its risks in a balanced manner; and 
  • reveal material facts about the drug.

Using digital transformation softwares, you can create an internal audit trail to establish that any promotional materials used by your sales force have been reviewed and approved for use in the field by your internal legal counsel. An electronic timestamp verifies who signed off on your marketing materials and when they did so, thus efficiently documenting compliance with your company’s review guidelines.

Promote Compliance with Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals

The Pharmaceutical Research and Manufacturers of America (PhRMA) organization, which represents research-based pharmaceutical and biotechnology companies, has issued its Code on Interactions with Health Care Professionals. The Code, which was most recently updated in October 2019, sets out 15 principals that address interactions between pharmaceutical companies, their sales representatives and health care professionals. In addition, PhRMA has appended to the Code a series of helpful Questions & Answers that relate to various situations that might arise in the conduct of marketing activities. Topics covered include the prohibition on entertainment and recreational expenses, training and conduct of drug company representatives and when it may be appropriate to offer health care professionals certain educational items. 

Developing an interactive digital experience covering the 15 principals and related Q&A materials would be an excellent way to engage with your sales force. One day of filming scenarios based on these materials could be distributed digitally in a format that enables your salespeople to demonstrate their understanding of the ethical concepts covered. This approach would provide an engaging experience for promoting compliance with PhRMA’s Code. 

How IdeaFORGE® can help with Pharmaceutical Digital Transformation

Creating a frictionless experience that follows the entire journey from research and development to go-to-market for all content capture requirements is where IdeaFORGE® shines. Our technology has been built from the ground up to enable fine grained control over all major media formats of communication to enable easier compliance, audit, and tracking of content through the use of our modular component IdeaBlocks. We would love to explore how our next generation technology can assist your organization achieve its digital transformation objectives and save you time and money.

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