[All presenters individually mute until your section.] Andrew: Welcome to the AdvaMed webinar, “Real-Life Compliance Solutions: Dissemination of Promotional, Scientific and Educational Content”. My name is Andrew Calhoun, and I am the VP of Membership for AdvaMed. Today’s webinar will be 75 minutes long, so let’s get started. Next slide. [Lisa, go to full screen mode]
Andrew: We will start today with a few housekeeping items followed by speaker introductions and then dive into the core of this webinar. There will be 20 minutes for questions and answers at the end. Next slide.
Andrew: Elsa Abruzzo is President of the regulatory consulting firm, ARAC LLC, and has nearly 20 years of domestic and international regulatory, quality and clinical experience. Her track record includes innovative Class II/III medical devices such as embolic devices, tissue heart valves, surgical adhesives, and active implantables. She has designed, developed and managed domestic and international clinical trials, including Bayesian adaptive designs trials. Additionally, Elsa has developed and implemented global regulatory strategies for multiple product lines, resulting in commercialization of products around the world. Elsa has worked at companies such as Baxter, Cordis, Johnson and Johnson, CryoLife, Percutaneous Valve Technologies, AtriCure, InnerPulse, and Merlin MD. Steve Skwara is a Partner at the Washington law firm, Epstein Becker and Green. He provides life sciences firms, providers and third-party payers with counsel on compliance to avoid fraud and abuse and liability claims. He is also an expert litigator in government investigations and False Claims Act cases. Prior to working at EBG, Mr. Skwara was the Director of the Fraud Investigation Unit and Associate General Counsel at Blue Cross and Blue Shield of Massachusetts, Inc. Under Mr. Skwara’s management, BCBSMA’s Fraud Investigation Unit initiated numerous criminal prosecutions and civil lawsuits and won the first-ever &quot;Best of Blue&quot; award for antifraud programs from the Blue Cross Blue Shield Association. For many years, Mr. Skwara served as a board member and officer for the National Healthcare Antifraud Association. Next slide.
Elsa: Thank you Andrew. Good afternoon everyone, my name is Elsa Abruzzo. Thank you very much for taking the time to listen in today. We will be covering a process that we developed in part at a former company of mine where we were dealing in a complex regulatory landscape. This process has been further developed with time and collaboration with my legal and marketing colleagues. Today, we will be addressing the dissemination of tangible and digital materials with a nod to oral dissemination, but the former will be our focus. Next slide.
Elsa: We are all aware of the increasingly difficult landscape which we are all navigating daily. It is becoming more complex for the regulatory, legal and compliance functions as well as for our teammates in the sales and marketing functions. Combine that with more demands on our time and fewer resources with which to accomplish them, and increasingly we are finding that the processes that interconnect us, such as review and approval of new content , are breaking down. Next slide.
Elsa: GMP was established in 1938 in response to quality issues with food, drugs and cosmetics. In the subsequent years, GMP processes have morphed to proactively build quality in vs. inspecting it out. I would propose that we are currently facing numerous “quality” issues with promotional and non-promotional materials and that the DOJ, FDA and other regulatory bodies are currently “inspecting it out” through their enforcement efforts. In order to protect our companies and our sales staff, I believe that we should consider the development of proactive, consistent processes surrounding the dissemination of promotional and non-promotional materials . For the purpose of today, we are going to discuss the four-step PACE process which when combined with a system for implementation, results in a Communications History Record, or CHR. Steve Skwara will speak later about the overwhelming data compelling medical device companies to develop CHRs. Next slide.
Elsa: First, let me introduce PACE. PACE is a straightforward four-step process for collaborative review and dissemination of tangible and digital content. Prepare, Analyze, Categorize, Execute. Think of PACE as a vaccine protecting your company against risk. Steve will speak later about what happens when preventative measures fail to vaccinate your company fully against liability. PACE is simple and provides transparency and consistency. Additionally, it provides the opportunity to bring key stakeholders, including regulatory, legal, and marketing, together to collaborate. Lastly, these systematic development and approval processes are the building blocks for a CHR which will help you and your company in a worse-case scenario. And , I’ve used it at a previous company in a very complicated regulatory situation and it works. Today, we will introduce the PACE process and in subsequent webinars, we will address different types of materials in greater detail. Next slide.
Elsa: The first step in PACE is Prepare . There are three key steps to Prepare. First, this approach will only work if you have approval at the appropriate management or executive level. This is an important initiative and it is cross-functional – spanning, for example, regulatory, clinical, legal and marketing. What this means is that it will take longer to set up initially but that PACE will have staying power within your organization. Secondly, you will need to establish a cross-functional content review committee. In the beginning, there will be much to consider during the initial implementation and much like product design, the better the input and involvement at the concept stage, the more efficient and effective the outcome. Consider involving the personnel at the level required for SOP signoff. At larger organizations, it may be initiated within the governance structure with a CCO’s backing and then moved into the different business units or divisions. At smaller organizations, it will depend on available personnel and company structure. My experience is that a key to success is regularly scheduled meetings. If your company is releasing new products, conducting clinical trials, releasing new indications – once a week is ideal on a set day at a set time. Consistency in personnel breeds consistency in decision-making and outcomes. Comprehensiveness in approval mitigates risk. You will find that over time the SOP with the integrated approval form will become more detailed and you will reach a point when the approvals can be handed down the organization. Over time, we broadened our purview to include concept review of marketing materials – some companies may refer to this as the project or marketing brief. We found that though this increased review at the front end, that marketing did not pursue paths and discover near the end that the content was not approvable. So, in fact, they embraced PACE over time. This is something that will initially require education and encouragement. Next slide.
Elsa: The second step in PACE is Analyze since there is a broad range of rules to consider. First, identify the claims being made. Then, compare the claims against a internal marketing standards book which includes “yes” and “no” words and terminology and set time basis for updating of key numbers in documents and citations. This will ensure consistency and communication of brand and claims standards over time both across functions and up and down your organization. Compare the claims against the approved or cleared indications as well as geographical rule sets checked on the form. And, increasingly you may wish to consider public opinion in the review of the content. Even though fair balance does not YET apply to medical devices, you may wish to consider it as public opinion increasingly has equal expectations of medical devices, which they mentally group up with pharma. Lastly, with the proliferation of the internet, email and social media, we liked to presume that every document will be in hands of competitors, FDA, patients and lawyers within days of approval. And, we balanced this with assuming that if it is extremely important, we need to consider if there is a compliant way to give them what they need in a compliant fashion to prevent any desire to circumvent the system. Remember, people are resourceful – so try to be helpful within the appropriate boundaries. Next slide.
Elsa: We have reviewed the first two steps of PACE – Prepare and Analyze. Step Three is Categorize. First, back in the prepare stage we talked about setting up an SOP and approval form for material approval and dissemination. You will want to review the types of content within your company and categorize or code in a way that fits your company. We found that quarterly review of disclaimers, associated rules and the categories was helpful. In the first year of implementation, we found that we expanded categories, refined the SOP and approval form. After a year, the categories and disclaimers largely stabilized. Some examples of categories that would stimulate a different rule set may include general promotional, disease awareness, journal reprints containing unapproved product uses and internal use only materials. Categorizing your content systematizes the application of rules and is crucial to consistency. Categories do not apply here to type of media but to the rules, disclaimers and dissemination associated. There may also be situations such as in dissemination of clinical trial materials where an approval routing is needed or in the case of unapproved use journal reprints where data collection, such as hospital name, HCP status and city state are collected. Next slide.
Elsa: Step Four of PACE: Prepare, Analyze, Categorize and now Execute. Execution is critical to success. Internal training is important, but so is sales training. Ideally the rollout of the new system and categories would occur at a pre-scheduled sales meeting(s) where marketing and regulatory can be on hand to answer questions and potential concerns. Always remember to frame the system in the context of what’s in it for them – this will gain their interest. Some systems which will talk about in a minute will offer more benefits for them than others. They will also need to understand that this helps protect them and the company. I recommend setting up regular proactive monitoring and auditing and incorporating this in the SOP as well. Systems that gather this information and provide reporting will make this easier for you and your company. Perhaps most importantly, listen listen and listen. Make change to the procedure collaboratively and set expectations at the outset that this is a continuous learning process – adaptive to legislative changes and internal needs. Most importantly, since you have a consistent system, the changes that are made are incorporated into SOP and training, ensuring ongoing consistency. [Real-life: Mention FDA inspection, process and result (BIMO and ???) When Your Competitors Create Roadblocks: Responding to Inquiries – Elsa, you need to script this section] Next slide.
Elsa: So, you have gone to a great deal of effort to approve the content and provide guidance for content usage. The question remains as how to control dissemination of the materials. Here is where sales adoption is paramount. Sales needs to see what is in it for them. There are a number of options to control dissemination. We have all used and many may still use manual fulfillment houses whether internal or external to the company. My experience has been that they are expensive and updating content within marketing is slow and costly which also impedes rapid response to changing market conditions. And, it relies on sales remembering not only how to sell but to be mini regulatory experts. Your company may chose to route certain requests through medical affairs or medical information to control dissemination – but resources are an issue and there is still no traceability to the end customer. Pushing content out to an intranet is a great start, but you will need to assess how often sales will be online with their laptops to ensure success with this strategy. This however accommodates rapid response to changing conditions as much of the content is digital and easily updated and reposted. And, it is a low cost strategy for smaller companies with simple rule sets. Digital CMS, or content management systems, moves the control in dissemination one step further. Marketing can respond rapidly to changes and upload them quickly. Finance appreciates the cost savings. And, there is reduced concern about old materials in circulation being used. However some systems can allow sales to download content – thereby taking it immediately out of the digital control loop. What you will need to consider here is whether the CMS is robust or industry-specific enough to accommodate the myriad rule sets while testing for high sales and marketing adoption. Highly adoptable AND compliant systems creates the environment that allows sales to be compliant. The system I am f amiliar with is Prolifiq but you will want to determine which approach is ideal for your company’s needs based on volume of activity and level of risk. Next slide.
Steve: Thank you Elsa. AS YOU LEARNED FROM THE INTRODUCTION, MY NAME IS STEVE SKWARA. I AM A PARTNER AT EPSTEIN BECKER & GREEN IN WASHINGTON DC. I SPECIALIZE IN LITIGATION AND GOVERNMENT INVESTIGATIONS FOR HEALTH CARE CLIENTS, AND, AS A NATURAL OUTGROWTH OF THAT WORK, ALSO ADVISE CLIENTS ON HEALTH CARE COMPLIANCE ISSUES. FOLLOWING UP ON ELSA’S PRESENTATION, I AM GOING TO SPEAK FOR A FEW MINUTES ABOUT SOME OF THE PRACTICAL ISSUES THAT ARISE IN THE COURSE OF LITIGATION AND INVESTIGATIONS SURROUNDING COMMUNICATIONS BETWEEN LIFE SCIENCES COMPANIES AND THEIR CUSTOMERS AND OFFER SOME OBSERVATIONS, BASED ON EXPERIENCE, ABOUT THE BENEFITS OF PROCESSES AND PROCEDURES THAT ALLOW A LIFE SCIENCES COMPANY TO CLOSELY MANAGE ITS PRODUCT-RELATED COMMUNICATIONS WITH CUSTOMERS. Next slide.
Steve: I SUSPECT THAT EVERYONE ON THE CALL IS AWARE OF THE AMOUNT OF INVESTIGATORY AND RELATED ACTIVITY IN THE LIFE SCIENCES SECTOR CONCERNING OFF-LABEL PROMOTION AND OTHER ASPECTS OF THE RELATIONSHIPS BETWEEN LIFE SCIENCES COMPANIES AND THEIR PROVIDER CUSTOMERS SO I AM NOT GOING TO DWELL ON THE SUBSTANCE OF THOSE ISSUES. I WILL SAY THAT ONCE A GOVERNMENT AGENCY, LIKE THE DOJ OR FDA, GETS ITS TEETH INTO A MATTER, THEY BECOME VERY INTERESTED IN EXPLORING THE DOCUMENTED HISTORY OF A LIFE SCIENCES COMPANY’S COMMUNICATIONS WITH CUSTOMERS OR POTENTIAL CUSTOMERS. WITH THAT, WE START OUT THINKING ABOUT HOW THE PROCESS THAT ELSA DESCRIBED MIGHT TRANSLATE INTO REAL, PRACTICAL BENEFITS ONCE A COMPANY IS SUBJECT TO SCRUTINY OF ANY KIND. FROM MY PERSPECTIVE, IT IS EASIER IN MANY RESPECTS TO DEFEND OR REACT TO LITIGATION OR INVESTIGATORY INQUIRIES WHERE THE COMPANY AT ISSUE HAS, AS THE SLIDE SAYS, “STARTED WITH THE END IN MIND.” WHERE A COMPANY HAS ESTABLISHED A CLEAR DOCUMENTED PROCESS FOR ITS CUSTOMER COMMUNICATIONS, I CAN BE RELATIVELY MORE CONFIDENT THAT IT HAS TRIED TO CONTROL THE CONTENTS OF ITS COMMUNICATIONS WITH CUSTOMERS. THIS PROCESS ALONE CAN BE CITED AS PROOF THAT THE COMPANY WAS AWARE OF, AND STRIVED TO MEET, ITS COMPLIANCE OBLIGATIONS. WHILE THAT ALONE WON’T END AN INVESTIGATION OR INQUIRY, IT’S HELPFUL TO SHOW THAT AT THE CORPORATE LEVEL, THIS IS A COMPANY THAT TOOK AFFIRMATIVE STEPS TO ENSURE COMPLIANT COMMUNICATIONS AND WAS TRYING TO DO THE RIGHT THING. EVEN BETTER IS IF THE COMPANY DOCUMENTED ITS COMMUNICATIONS THOROUGHLY, OR END TO END, SHOWING THINGS LIKE WHO REQUESTED INFORMATION, WHEN, WHY, AND WHAT WAS SENT. IN A FEW MINUTES, I’LL DISCUSS WHERE THIS HAS BECOME A REQUIREMENT IN CORPORATE INTEGRITY AGREEMENTS BETWEEN HHS-OIG AND LIFE SCIENCES COMPANIES. IN ADDITION TO HAVING TRACKED INFORMATION, EVEN BETTER FROM THE PERSPECTIVE OF DEFENDING A COMPANY, IS EVIDENCE THAT THE COMPANY SYSTEMATICALLY MONITORED THE COMMUNICATIONS TRAFFIC BETWEEN ITS SALES REPRESENTATIVES AND CUSTOMERS FOR PURPOSES OF DETECTING INCIDENTS OR PATTERNS THAT MIGHT WARRANT FURTHER REVIEW. FOR EXAMPLE, A LARGE VOLUME OF COMMUNICATIONS INVOLVING AN “OFF-LABEL” REPRINT FROM A PARTICULAR SALES REPRESENTATIVE MIGHT WARRANT FURTHER INQUIRY TO ENSURE THAT THE SALES REPRESENTATIVE UNDERSTANDS THE COMPANY’S COMPLIANCE POLICIES. SO, I START WITH THE SIMPLE PROPOSITION THAT A BUILT-IN ELECTRONIC COMMUNICATIONS HISTORY RECORD IS, ON THE WHOLE, A GOOD THING WHEN REPRESENTING A LIFE SCIENCES COMPANY IN LITIGATION OR INVESTIGATIONS BECAUSE IT SHOWS IN THE FIRST INSTANCE THAT THE COMPANY WAS TRYING TO DO THE RIGHT THINGS COMPLIANCE-WISE. Next slide.
Steve: ONE OF THE OTHER GOOD THINGS ABOUT A CONTROLLED COMMUNICATIONS HISTORY IS THAT IT CAN HELP TO MINIMIZE THE EXPENSE AND DISTRACTION OF RESPONDING TO LITIGATION, INVESTIGATION, OR REGULATORY RELATED INQUIRIES. WHAT HAS HAPPENED OVER THE PAST DECADE OR SO IS THAT THE COSTS OF RETRIEVING INFORMATION IN ADVERSARIAL CASES HAS GROWN EXPONENTIALLY. WHERE ONCE ALL LAWYERS HAD TO DO WAS PHOTOCOPY A FILE CABINET OF DOCUMENTS, NOW THEY HAVE TO BE EXPERTS IN RETRIEVAL OF ELECTRONIC INFORMATION INCLUDING EMAILS, TEXT MESSAGES, AND OTHER ELECTRONIC DOCUMENTS. CONSIDER A DOCUMENT REQUEST, PERHAPS IN A SUBPOENA, THAT ASKS A COMPANY TO TURN OVER “ALL COMMUNICATIONS BETWEEN SALES AND PROVIDERS.” WHILE THIS EXAMPLE MAY BE A BIT EXAGGERATED, IT’S NOT FAR OFF FROM WHAT A GOVERNMENT AGENCY MIGHT REQUEST, SAY, WHEN INVESTIGATING AN “OFF LABEL” PROMOTION CASE. THEY WANT TO SEE ALL OF THE COMMUNICATIONS AND INFORMATION THAT WAS EXCHANGED. NOW CONSIDER THE EXPENSES ASSOCIATED WITH RESPONDING TO THAT REQUEST AS IT IS WRITTEN. IT WOULD, FOR INSTANCE, INCLUDE TEXT MESSAGES SENT FROM A SALESPERSON’S BLACKBERRY TO A CUSTOMER. IN A RECENT CASE, I WAS GIVEN A QUOTE OF $500/BLACKBERRY JUST TO RETRIEVE THE CONTENTS OF THE DEVICE. THAT DIDN’T EVEN COVER THE EXPENSE OF HAVING SOMEONE REVIEW THE CONTENTS TO SEE IF IT FELL WITHIN THE GOVERNMENT’S DOCUMENT REQUEST. BASICALLY, THE MORE CHANNELS THROUGH WHICH A COMPANY COMMUNICATES WITH CUSTOMERS, OR THE MORE DECENTRALIZED THESE COMMUNICATIONS ARE, THE GREATER THE EXPENSE OF HAVING TO IDENTIFY AND RETRIEVE THIS INFORMATION. ADDITIONALLY, DECENTRALIZATION MAKES MONITORING OF COMMUNICATIONS MORE DIFFICULT AND MAY INCREASE COMPANY EXPOSURE. I’VE EMPHASIZED THIS POINT GRAPHICALLY IN THE NEXT SLIDE.
Steve: THE COSTS OF ELECTRONIC INFORMATION RETRIEVAL IN INVESTIGATIONS AND LITIGATION CAN OFTEN EXCEED THE SUBSTANTIVE LEGAL FEES, WHICH THEMSELVES ARE OFTEN STAGGERING. BY WAY OF ILLUSTRATION, THIS SLIDE SHOWS A TYPICAL BREAKDOWN OF THE EXPENSES IN A CASE INVOLVING “E-DISCOVERY.” THE TOP OF THE PYRAMID SHOWS THE CLASSIC LEGAL TASKS, LIKE BRIEF-WRITING, COURT APPEARANCES, MEETINGS, ETC. THAT EVERYONE ANTICIPATES FROM THEIR ATTORNEYS. THE BOTTOM SHOWS THE RELATIVE COSTS OF MERELY RETRIEVING INFORMATION TO BE USED IN CONNECTION WITH THE LEGAL ACTIVITIES – WHICH TYPICALLY EXCEED ATTORNEYS’ FEES. IT’S NOT A PRETTY PYRAMID. I ILLUSTRATE THESE COSTS OF E-DISCOVERY BECAUSE THERE ARE STEPS THAT COMPANIES CAN TAKE TO ANTICIPATE, AND HOPEFULLY MINIMIZE THEM. THIS ISN’T A TALK ABOUT AN ENTERPRISE-WIDE PREPARATION FOR E-DISCOVERY, BUT IN THE CONTEXT OF OUR DISCUSSION TODAY, I SUGGEST THAT A CENTRALIZED, CONTROLLED, AND COMPREHENSIVE DATABASE THAT TRACKS AND MONITORS THE EXCHANGE OF INFORMATION BETWEEN LIFE SCIENCES COMPANIES AND THEIR CUSTOMERS COULD HELP ADDRESS THE COSTS AND DISTRACTION OF E-DISCOVERY. THAT’S ONE POTENTIAL BENEFIT. AS DESCRIBED ON THE NEXT SLIDE,
Steve: SUCH A DATABASE OR CATALOGUE ALSO HELPS IN RESPONSE TO AD HOC INQUIRIES. A COMPANY, OR ITS ATTORNEY, CAN IN THEORY QUICKLY RESPOND TO SUCH INQUIRIES, WHETHER FROM THE FDA OR A COMPETITOR, AND BE CONFIDENT THAT IT IS DOING SO IN A COMPREHENSIVE WAY. ALSO, AS MENTIONED A FEW MOMENTS AGO, IT ALLOWS FOR THE PINPOINTING OF INFORMATION ABOUT SPECIFIC INDIVIDUALS, RECIPIENTS, GEOGRAPHIC AREA, ETC. THE ADVANTAGES OF SUCH A PROCESS OR SYSTEM ARE PRETTY OBVIOUS, BUT I’LL ALSO ADD THAT THE ABILITY TO QUICKLY AND COMPREHENSIVELY RETRIEVE INFORMATION MAY HAVE AN ADDITIONAL POSITIVE EFFECT. IF YOU CAN RESPOND TO, SAY, AN FDA INQUIRY IN A MATTER OF DAYS WITH COMPREHENSIVE INFORMATION, I WOULD SUBMIT THAT AT SOME LEVEL THAT LEAVES A MORE POSITIVE IMPRESSION WITH THE REQUESTING AGENCY THAN IF IT TAKES YOU WEEKS OR MONTHS TO RETRIEVE THE SAME INFORMATION BECAUSE, FOR EXAMPLE, YOU HAVE TO DO A SEARCH REGION-BY-REGION, OR EMPLOYEE-BY-EMPLOYEE, OR SOME OTHER RELATIVELY INEFFICIENT PROCESS. Next Slide.
Steve: ALSO, AS A LITIGATOR, IT IS HELPFUL TO HAVE AN ORGANIZED DATABASE OF POTENTIALLY SENSITIVE COMMUNICATIONS BECAUSE IT HELPS ME GET A GOOD, EFFICIENT OVERVIEW OF THE COMPANY’S SALES BEHAVIOR AND INTERACTIONS WITH CUSTOMERS. HAVING A COMPREHENSIVE, ORGANIZED PROCESS CREATES EFFICIENCIES HERE AND LETS THE ATTORNEY GET ON WITH THE DEFENSE RATHER THAN SPENDING A LOT OF TIME TRYING TO RECREATE A COMPANY’S COMMUNICATIONS HISTORY. BACK TO E-DISCOVERY FOR A MINUTE. WHILE THIS SPECIFIC SCENARIO HASN’T PLAYED OUT IN ANY CASES THAT I’M AWARE OF YET, THE RULES OF CIVIL PROCEDURE IN FEDERAL CASES PROVIDE FOR COST-SHIFTING IN THE CONTEXT OF E-DISCOVERY IN CERTAIN CIRCUMSTANCES WHERE THE COST OF RETRIEVING INFORMATION OUTWEIGHS THE POTENTIAL EVIDENTIARY VALUE OF THAT INFORMATION. I CAN SEE MAKING AN ARGUMENT WHERE A LIFE SCIENCES COMPANY THAT COMPREHENSIVELY TRACKS ELECTRONIC COMMUNICATIONS BETWEEN ITSELF AND CUSTOMERS COULD POINT TO THE TRACKING DATABASE AND SAY, WITH CONFIDENCE, THAT THAT DATABASE CONTAINS MOST, IF NOT ALL, OF THE INFORMATION THAT NEEDS TO BE TURNED OVER. THE COST OF LOOKING ELSEWHERE FOR ELECTRONIC INFORMATION OUGHT TO BE BORNE BY THE GOVERNMENT, OR WHOEVER IS SEEKING THE INFORMATION IN LITIGATION IF THEY ARE GOING TO INSIST UPON A BROADER DOCUMENT PRODUCTION. CHANGING GEARS HERE AS WE GO TO THE NEXT SLIDE.
Steve: THERE HAVE BEEN A NUMBER OF CORPORATE INTEGRITY AGREEMENTS IN CONNECTION WITH RECENT SETTLEMENTS OF OFF-LABEL PROMOTION CASES BETWEEN LIFE SCIENCES COMPANIES AND THE FEDERAL GOVERNMENT. BY WAY OF BACKGROUND, THE OFFICE OF INSPECTOR GENERAL FOR HEALTH AND HUMAN SERVICES WILL TYPICALLY REQUIRE THAT COMPANIES ENTER INTO A CORPORATE INTEGRITY AGREEMENT, OR “CIA,” AS PART OF A GLOBAL SETTLEMENT AGREEMENT. THE CIAS GENERALLY REQUIRE THAT THE SUBJECT COMPANY ENACT OR FOLLOW CERTAIN COMPLIANCE-RELATED POLICIES AND PROCEDURES FOR A DEFINED PERIOD OF TIME. WHILE THESE CIAS ARE NOT BINDING, OF COURSE, UPON OTHER COMPANIES THAT AREN’T PARTIES TO THE AGREEMENTS, WE LOOK AT THEM TO TRY AND DISCERN WHAT THE GOVERNMENT’S THINKING IS WITH RESPECT TO COMPLIANCE. I WON’T GO SO FAR AS TO SAY THAT THE CIAS EMBODY “BEST PRACTICES,” BUT I WILL SAY THAT THEY ARE USEFUL GUIDANCE, OR AT LEAST EDUCATIONAL MATERIAL, FOR LIFE SCIENCES COMPANIES TO CONSIDER WHEN ASSESSING THE ADEQUACY OF THEIR OWN COMPLIANCE PROGRAMS. SEVERAL RECENT CIAS ADDRESS THE CONCEPTS THAT WE HAVE BEEN DISCUSSING TODAY. THAT IS, THESE CIAS REQUIRE COMPANIES TO CLOSELY TRACK, MANAGE, AND MONITOR THEIR COMMUNICATIONS WITH PROVIDERS IN ORDER TO ENSURE COMPLIANT COMMUNICATIONS. THEY ALSO PROVIDE FOR A PROCESS BY WHICH COMMUNICATIONS AROUND OFF-LABEL SCIENTIFIC INFORMATION, OR JOURNAL ARTICLES, ARE CHANNELLED THROUGH WHAT I CALL A “GATEKEEPER” WHICH IS RESPONSIBLE FOR COMPLIANCE AND IS RESPONSIBLE FOR TRACKING AND MONITORING COMMUNICATIONS. IN LARGER LIFE SCIENCES COMPANIES, THE GATEKEEPER MIGHT BE A “MEDICAL INFORMATION” BUSINESS UNIT OR SOMETHING WITH A SIMILAR FUNCTION AND TITLE. UNDER THE CIAS, REQUESTS AND RESPONSES TO REQUESTS FOR INFORMATION ABOUT “OFF LABEL” PRODUCT INFORMATION ARE TO BE ROUTED THROUGH THIS “GATEKEEPER” AND NOT HANDLED EXCLUSIVELY BY SALES REPRESENTATIVES. THE “GATEKEEPER” SERVES AS A COMPLIANCE CHECK AND BALANCE AND IS RESPONSIBLE FOR MAKING SURE THAT THE COMPANY’S COMPLIANCE POLICIES AND PROCEDURES ARE FOLLOWED IN CONNECTION WITH DISSEMINATION OF PROMOTIONAL MATERIALS TO CUSTOMERS. IN ADDITION TO THE “GATEKEEPER” CONCEPT, THE CIAS ALSO REQUIRE THAT THE COMPANIES, THROUGH THE “GATEKEEPER,” SET UP A DATABASE OF COMMUNICATIONS WITH CUSTOMERS, INCLUDING THE WHO/WHAT/WHERE/WHY/HOW/WHEN INFORMATION BEARING ON THE DISTRIBUTION OF INFORMATION. ALSO, THE CIAS REQUIRE THAT THESE COMMUNICATIONS DATABASES BE MONITORED FOR ABERRATIONS AND ANTICIPATE THAT THE DATABASES WILL HAVE TRIGGERING MECHANISMS FOR SITUATIONS WHERE, SAY, A SALES REPRESENTATIVE MAY BE REQUESTING OR SENDING AN INORDINATE AMOUNT OF “OFF LABEL” INFORMATION TO POTENTIAL CUSTOMERS. THE CIAS, OF COURSE, ONLY TECHNICALLY APPLY TO THE COMPANIES SIGNING THEM, BUT WE CAN CONCLUDE FROM THEM THAT THE GOVERNMENT WOULD LIKE TO SEE LIFE SCIENCES COMPANIES TRACK AND MONITOR THEIR PRODUCT-RELATED COMMUNICATIONS CLOSELY. AND THAT THE GOVERNMENT ALSO SEES THE IDEA OF A “GATEKEEPER” AS SIGNIFICANT FOR DISSEMINATION OF OFF-LABEL JOURNAL REPRINTS BECAUSE IT CREATES SEPARATION BETWEEN THE SALES AND PROMOTION FUNCTION AND THE COMPLIANCE FUNCTION. NOW, NOT ALL LIFE SCIENCES COMPANIES ARE MAMMOTH ENTERPRISES THAT CAN SUPPORT A MEDICAL INFORMATION DEPARTMENT. WHERE AN INDEPENDENT DEPARTMENT IS NOT FEASIBLE, THE “GATEKEEPER” CONCEPT CAN STILL BE ADOPTED THROUGH, FOR EXAMPLE, A COMMITTEE – SEPARATE FROM SALES – RESPONSIBLE FOR ENSURING COMPLIANT COMMUNICATIONS AND TRACKING AND MONITORING THOSE COMMUNICATIONS. I NOTE TOO THAT THESE DAYS, IT’S NOT JUST THE FEDERAL GOVERNMENT THAT IS INTERESTED IN THESE ISSUES. STATES ARE GETTING IN ON THE ACT AND HAVE BEGUN TO REGULATE ASPECTS OF LIFE SCIENCES COMPANY AND PROVIDER INTERACTION. AS THIS STATE-LEVEL INTEREST DEVELOPS, WE GIVE THE EXAMPLE OF VERMONT’S PHYSICIAN PAYMENT LAW, THERE WILL BE ADDED COMPLIANCE CONSIDERATIONS THAT COULD BE INTEGRATED INTO A CONTROLLED INFORMATON DISTRIBUTION ENVIRONMENT. I HAVE WRITTEN A HIGH-LEVEL ARTICLE TOUCHING ON THESE CONCEPTS, AND IT SHOULD SOON BE AVAILABLE ON THE PROLIFIQ WEBSITE AND MY FIRM’S WEBSITE. IT WILL GIVE YOU A BIT MORE DETAIL ON THESE CONCEPTS AND POINT YOU TO THE CIAS IF YOU’RE INTERESTED IN THOSE DETAILS. THE LESSON, IF THERE IS A “LESSON” HERE, IS THAT THE GOVERNMENT, AT LEAST HHS-OIG, THINKS IT’S A GOOD IDEA TO CLOSELY TRACK AND MONITOR CUSTOMER COMMUNICATIONS, ESPECIALLY AS THEY RELATE TO “OFF LABEL” PRODUCT USE. THAT MAY BE AN OBVIOUS POINT, BUT THE SPECIFIC REQUIREMENTS IN THE CIAS DO LAY OUT A DETAILED PATHWAY FOR THIS FUNCTION, ONE THAT MAY BE MORE DETAILED AND TECHNICALLY DEMANDING THAN CURRENT COMPLIANCE PROGRAMS IN THE INDUSTRY MAY HAVE. SO, TO SUMMARIZE, FROM THE LITIGATION AND INVESTIGATIONS PERSPECTIVE, IT CAN BE USEFUL FOR LIFE SCIENCES COMPANIES – WHEN “PREPARING FOR THE WORST” – TO THINK ABOUT THE POTENTIAL BENEFITS OF HAVING A CONTROLLED, DOCUMENTED, TRANSPARENT COMMUNICATIONS PROCESS. CLEARLY, SOME COMPANIES HAVE ALREADY DONE THIS. AND SOME COMPANIES HAVE TO DO IT UNDER THE CIAS THAT I DESCRIBED. SUCH COMMUNICATIONS CONTROL WON’T BE A “MAGIC BULLET” THAT WILL AUTOMATICALLY GET A COMPANY OUT OF HOT WATER, BUT IT CAN BE OF SIGNIFICANT BENEFIT FOR THE REASONS THAT I MENTIONED – E-DISCOVERY, ASSESSING LEGAL STRATEGY, RESPONDING TO AD HOC INQUIRIES -- IF AND WHEN A COMPANY FINDS ITSELF UNDER SCRUTINY. Next slide.
Maureen: Thank you Steve. Good afternoon everyone and thank you for joining us today. My name is Maureen Shaffer, and I am the Vice President of Life Sciences for Prolifiq. A few brief minutes before we move into Q&A to show you one possible system for organizing your communications into a categorized and centralized CHR per Elsa and Steve’s talks. As background, prior to Prolifiq, I spent more than 20 years in marketing for medical device companies. And, although I was initially hired at Cordis as an engineer, I lobbied my way into the marketing department after one short year to be closer to the customer and patients. I stayed the course in marketing through US Surgical, Heartport, and AtriCure peppered with a few small startup companies along the way. I jumped into the IT space and joined Prolifiq six (6) months ago to head up their entry into the Life Sciences arena. And, today we provide software and solutions for Good Promotional Practices which leverage the PACE process about which Elsa spoke and embeds the CHR about which Steve spoke . Next slide please.
Maureen: Prolifiq has developed an intuitive system to satisfy the requirements of sales and marketing, as well as compliance, regulatory and legal. We like to call it, “sales-friendly compliance” – to which some potential customers have responded, such as at the recent RAPS conference, “isn’t that an oxymoron?” Well, as Prolifiq’s first life science customer, I can tell you that “sales-friendly compliance” is no longer an oxymoron. As you have heard from Elsa and Steve, we are living in an increasingly complicated environment for promotional, scientific and educational content dissemination. There are more sales channels and more decision makers on the healthcare side than there ever have been before. And, timely access to key information is increasingly critical, including reimbursement information, journal articles for both approved and unapproved uses as well as standard promotional information. With the increasing breadth and depth of rules and rising enforcement, it was time for a new paradigm for dissemination of content. So what does Prolifiq have? Prolifiq provides three things. First, your sales organization has access to all the content you deem appropriate on their mobile device – from the . And, by access what I mean is, they can choose and send material on their mobile device but cannot directly access the material. There is no more logging into complicated VPN systems or intranets or, worse, downloading the material onto their hard drive where it may never be updated and is impossible to track. Sales is allowed access to this broad range of materials because all the necessary rules are built digitally and proactively behind the scenes – protecting both themselves and your company . And, as part of this rulebook, marketing sets the branding standards for the message delivery. Additionally, for the first time, marketing, sales, regulatory, compliance and legal can track which materials the sales force uses and, more importantly, what their customers like . In addition to increased compliance and marketing branding, faster customer response times and, potentially, shorter sales cycles may result. Next slide please.
Maureen: Today, we heard Steve convey how a central content library and tracking reports can both protect your company as well as minimize costs in worst-case scenarios. And, Elsa spoke about how important categorization and consistent application of rule sets were important. Prolifiq accomplishes both of these in the digital rulebook and content library, as you see here. Prolifiq’s digital rulebook governs which content may be seen and sent by different roles. Additionally, content is managed on a cloud server. Hosting your content on a cloud server allows your marketing department to rapidly respond to content changes with version control, instant archiving and instant obsolescence. For example, if conditions change and a piece of content needs to updated, it is as simple as Marketing uploading a new revision. The previous revision is autoarchived. And, even if messages have already been sent, your customers only have access to the new revision through our virtual attachment technology. Taking that one step further, if you wish to obsolete content, it is a simple two-click process. The content is not only obsolete in the system, but it is no longer available – even in previously sent messages. Additionally, this rulebook allows you to set rules requiring, for example, data capture of first name, last name, and hospital for journal reprints as well as an automatic routing for approval, if so desired. We can even set autoattach so that documents in accordance with the Good Reprint Practices and a feedback mechanism are sent along with a request – while disallowing promotional material attachment. All of this is set up proactively in advance by you and all sales needs to know is what the customer asked for. Next slide.
Maureen: Steve spoke of the benefits of a CHR, or communications history record. This is Prolifiq’s CHR. We track who sent what to whom when complete with capturing their variable text, if they were allowed to include that. And, we hold these records securely for 7 years. You have multiple way to drill down into individual sales behavior, specific message usage and customer behavior along with powerful filters. I encourage you to check out Prolifiq’s solution at prolifiq with a q, dot net. Backslash life sciences – or at the upcoming AdvaMed tradeshow where we will be exhibiting. Thank you for your time and now back to the Q&A. Next slide please.
Andrew: Thank you Maureen. We would now like to hear from you about which webinar topic you would most like to see offered next. [Lisa, show poll.] You should now see the polling buttons available on your screen. We will leave the poll open during the Q&A and report the results during our closing remarks. Now, the operator will now explain how we will conduct our Q&A. [operator to explain] Elsa and Steve: Elsa, Thank you Andrew. Steve and I will now answer questions. [With 5 minutes to go, Andrew will end question period.] Andrew: Let’s show the poll results. [Lisa to show poll results] Great, it appears that the next webinar to be offered in this series is, “XXX”! Thank you for voting. Last slide please.
Compliant Dissemination of Promotional and Educational Material
Real-Life Compliance Solutions Part I: Dissemination of Promotional, Scientific and Educational Content Navigating Compliance Challenges of Product-Related Communications Series (75 min)
Agenda <ul><li>Housekeeping & Introductions (5 min) </li></ul><ul><li>Real-Life Compliance Solutions </li></ul><ul><ul><li>PACE: A Four-Step Process (20 min) </li></ul></ul><ul><ul><li>CHR: Prepared for the Worst (20 min) </li></ul></ul><ul><ul><li>A Word from our Sponsor (5 min) </li></ul></ul><ul><li>Questions and Answers (20 min) </li></ul><ul><li>Closing Remarks (5 min) </li></ul>
PACE: A Collaborative Process <ul><ul><li>Elsa Chi Abruzzo </li></ul></ul><ul><ul><li>President, ARAC, LLC </li></ul></ul><ul><li>(20 min) </li></ul>
Changing Landscape <ul><li>Regulatory, Compliance and Legal </li></ul><ul><ul><li>Expanding breadth and depth of regulations and guidelines </li></ul></ul><ul><ul><li>Increasing FDA, DOJ and SEC (FCPA) enforcement </li></ul></ul><ul><li>Sales and Marketing </li></ul><ul><ul><li>More decision makers </li></ul></ul><ul><ul><li>More sites of service </li></ul></ul><ul><li>Less time and fewer resources </li></ul>
Learn from GMP and DHR <ul><li>Response to quality issues </li></ul><ul><ul><li>Inefficient processes Efficient </li></ul></ul><ul><li>Central aspects of GxP are: </li></ul><ul><ul><li>Traceability: the ability to reconstruct history </li></ul></ul><ul><ul><li>Accountability: the ability to resolve who has done what and when </li></ul></ul><ul><li>PACE Process + Implement = CHR </li></ul>
P repare <ul><li>Obtain cross-functional executive approval </li></ul><ul><li>Establish cross-functional content review committee </li></ul><ul><ul><li>Strategic Governance Structure with CCO Oversight and/or, Tactical Cross-Functional PRC </li></ul></ul><ul><ul><li>SOP with objective criteria with approval form containing how and where this will be used </li></ul></ul><ul><ul><li>Regularly scheduled meetings </li></ul></ul><ul><li>Broaden purview to increase branding and compliance </li></ul><ul><ul><li>Solicit materials for review, including at the concept stage </li></ul></ul><ul><ul><li>Convince company employees broadly to submit materials for review </li></ul></ul>
A nalyze <ul><li>What are claims made </li></ul><ul><li>Compare claims against marketing standards book – time basis for updating </li></ul><ul><li>Which indications allowed </li></ul><ul><li>Geographical rule sets </li></ul><ul><ul><li>Federal/OUS, State, Local/Hospital or OUS: EU, Pac Rim, LA </li></ul></ul><ul><li>Company Guidelines </li></ul><ul><li>Ethical/Public Opinion: Fair balance, transparency </li></ul><ul><li>Assume rapid dissemination to competitors, FDA et al. </li></ul>
C ategorize <ul><li>Associate material with appropriate category </li></ul><ul><ul><li>Examples: General Promotional (G), Clinical Trial (C), Unapproved Use Journal Articles (Good Reprint Practices) (R), Unsolicited Requests (U), Disease Awareness (D), Internal Use Only (I) </li></ul></ul><ul><ul><li>Include categorization in PRC form, SOP and final approved material code </li></ul></ul><ul><ul><li>Category is approved along with the material </li></ul></ul><ul><li>Category drives rules = Consistency </li></ul><ul><ul><li>Disclaimers, risks, indications, approved labeling </li></ul></ul><ul><ul><li>Author and study funding disclosures for reprints </li></ul></ul><ul><ul><li>Approval routing for review of clinical trial content </li></ul></ul><ul><ul><li>Data collection for unapproved use reprint requests </li></ul></ul>
E xecute <ul><li>Educate and train across and up and down </li></ul><ul><ul><li>Document training and certification </li></ul></ul><ul><li>Audit and monitor sales behavior </li></ul><ul><ul><li>Regulations, CIAs </li></ul></ul><ul><li>Monitor customer usage and close-loop learning to improve materials </li></ul><ul><li>Listen, modify and repeat </li></ul>
Controlled Dissemination <ul><li>Manual fulfillment – frequent updates? </li></ul><ul><ul><li>Annual training – will they remember? </li></ul></ul><ul><ul><li>Medical Affairs – low on resources? </li></ul></ul><ul><li>Intranet – how often do reps log in? </li></ul><ul><li>Digital CMS </li></ul><ul><ul><li>Make the complex simple with technology </li></ul></ul><ul><ul><li>Efficiency and cost-savings with processes </li></ul></ul><ul><ul><li>Two choices </li></ul></ul><ul><ul><ul><li>Modify non industry-specific with compliance rules </li></ul></ul></ul><ul><ul><ul><li>Choose industry-specific with compliance rules </li></ul></ul></ul>
Communications History Record Prepared for the Worst <ul><ul><li>Steven Skwara </li></ul></ul><ul><ul><li>Partner, Epstein Becker & Green </li></ul></ul><ul><li>(20 min) </li></ul>
CHR: Start with End in Mind <ul><li>Clear, documented process </li></ul><ul><ul><li>Controlled library </li></ul></ul><ul><ul><li>Proof of meaningful compliance program </li></ul></ul><ul><li>End-to-end traceability </li></ul><ul><ul><li>Monitoring and immediate action </li></ul></ul><ul><ul><li>Transparency </li></ul></ul><ul><li>Built-in electronic communications history record (CHR) </li></ul>
Expense and Distraction <ul><li>Responding to inquiries from third-parties </li></ul><ul><ul><li>Regulatory </li></ul></ul><ul><ul><li>Investigatory </li></ul></ul><ul><ul><li>Litigation </li></ul></ul><ul><li>Staggering costs for information retrieval </li></ul><ul><ul><li>“ All communications between sales and providers” </li></ul></ul><ul><ul><li>Imaging one BlackBerry ~$500/ea before attorney review </li></ul></ul><ul><ul><li>Decentralized information sources multiply costs </li></ul></ul><ul><ul><li>May exceed attorneys’ fees </li></ul></ul>
E-Discovery Information Retrieval 50-80% of costs Attorney Fees 20-50% of costs
Responding to Ad Hoc Inquiries <ul><li>Retrieve quickly </li></ul><ul><li>Confident </li></ul><ul><li>Comprehensive </li></ul><ul><li>Pinpoint individuals, recipients, geography, products </li></ul><ul><li>Competition, FDA or other external inquiries </li></ul>Rx Compliance Report, Vol. VIII, Issue 7/May 5, 2009
Litigation and Investigations <ul><li>Shape legal strategy </li></ul><ul><ul><li>Organized database allowed quick overview of sales behavior and interactions: who sent what when to whom </li></ul></ul><ul><li>Time and cost savings </li></ul><ul><ul><li>Opportunity to argue that centralized system may allow cost shifting for additional discovery work </li></ul></ul><ul><li>In addition to ad hoc advantages </li></ul>
Recent CIAs: Material Dissemination <ul><li>Independent gatekeeper </li></ul><ul><li>Tracking database </li></ul><ul><ul><li>Substantive requirements </li></ul></ul><ul><ul><li>e.g., VT law </li></ul></ul><ul><li>Monitoring triggers </li></ul><ul><ul><li>e.g., high volume of purportedly unsolicited requests </li></ul></ul><ul><li>Practical Compliance Advice: Recent CIAs </li></ul><ul><ul><li>www.prolifiq.net/lifesciences </li></ul></ul><ul><ul><li>www.ebglaw.com in articles section </li></ul></ul>
Prolifiq for Life Sciences: Digital CMS with CHR <ul><ul><li>Maureen Shaffer </li></ul></ul><ul><ul><li>Vice President, Life Sciences Prolifiq </li></ul></ul><ul><li>(5 min) </li></ul>