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.
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.
Andrew: Thank you Elsa, Steve and all the participants on the call for your time today. Please look for an email from AdvaMed to all webinar attendees containing a link to this presentation. And, EBG has graciously provided access to a white paper on the recent CIAs -- a link for downloading will also be included. Thank you again and have a great day. [Lisa, save transcript, audio, q&a and anything else that can be saved and close presentation.]
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