Best Practices for Promotional Content Review
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The document outlines an agenda for a webinar on best practices for promotional content review. The webinar will cover what good promotional practices are, the importance of implementing them now, a four-step PACE process for content review, standard operating procedures for review, and a case study on tradeshow preparation. It includes slides on the key topics that will be discussed, such as establishing a cross-functional review committee and using categorization to ensure consistent application of review standards.
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Best Practices for Promotional Content Review
- 1. RAPS Webcast 29 September 2010 Best Practices for Promotional Content Review Good Promotional Practices Series www.goodpromotionalpractices.com (90 min)
- 2. Agenda • Housekeeping & Introductions (5 min) • Best Practices for Promotional Content Review – What is GPP? (10 min) – Criticality of Now for GPP (5 min) – PACE: A Four-Step Process (30 min) – SOPs for GPP (10 min) – Case Study: Tradeshow Prep (10 min) • Questions and Answers (15 min) • Closing Remarks (5 min)
- 3. Housekeeping • Audience muted – Minimize distractions • Submit questions • Address questions during Q&A • Poll questions throughout
- 4. Speaker Introductions • Elsa Chi Abruzzo – President/CEO, ARAC LLC • Maureen A. Shaffer – President/CEO, Mingletoe LLC • (then Vice President, Life Sciences, Prolifiq)
- 5. What is GPP? Maureen Shaffer VP, Life Sciences, Prolifiq (10 min)
- 6. Good Promotional Practices • Written & Oral Promotion = Labeling Design Control GMP GPP Human Factors
- 7. Systematic Content Creation Design Control Content Creation Functional specification Project brief Concept to launch Concept to launch Design reviews at critical stages Project reviews at critical stages Risk analysis Risk analysis Cross-functional team Cross-functional team
- 8. Systematic Content Control GMP Content Control Internal Procedures Internal and Field Procedures DHR CHR: Content History Record Traceability to Customer/Patient Traceability through Sales to Customer/Patient Training of tightly controlled staff Training of global field personnel Monitoring Monitoring in field with customers CAPA RAMP, ala Pfizer
- 9. Human Factors for Content Human Factors Content Environment Who Personas When Traceability to Customer/Patient Where Training How Monitoring Testing CAPA Human factors is the science and the methods used to make devices easier and safer to use. The Human Factors team advances the FDA’s patient safety mission by distributing information about the design, testing, and selection of usable medical devices for clinical and home settings. We work with manufacturers to help ensure the application of Human Factors engineering to the design of new products. We also help device users through identification and investigation of use-related errors.
- 10. Forget Compliance. Think Environment. • If device operation is overly complex or counter- sales compliance intuitive, safe and efficient use of a medical product content can be compromised. Both CDRH databases and research findings indicate that lack of attention to human factors during product development may lead content to errors that have the potential for patient injury, or company fines even death. The application of user interface design CIAs principles and participation of healthcare practitioners sales and field personnel in design analyses and tests are very important. content use
- 12. Poll Question • After communications are approved, do you have a system to monitor the use of these communications in the field down to the customer level? – Yes – No – Working on it – Don’t know
- 13. Criticality of Now for GPP Maureen Shaffer VP, Life Sciences, Prolifiq (5 min)
- 14. 9%!! Honesty Rating 9% trust
- 15. More Regulation • Levels – State, Federal, Association, Global • Specificity – FDA Good Reprints Practice • Breadth – Medical Device = Pharma = Biotech • Presenting Risk Information FDA draft • Good Reprints FDA guidance
- 16. Enforcement Heat Nets $1.6B In 2009, the government: • 1,014 new criminal healthcare fraud investigations • 1,786 potential defendants • 583 convictions for healthcare fraud • Commenced 886 civil healthcare fraud investigations • Won or negotiated approximately $1.63 billion in judgments or settlements.
- 17. FBI Techniques • “…we will be more targeted, more creative, and more strategic in where and how…” – Utilizing data and intelligence – Going undercover • “We are especially concerned about increased disparity in white-collar sentencing.” – Seeking mean prison sentence of 45 months for company employees
- 18. Individual Liability • Allergan Board – Sued by pension fund two days after $600M HHS settlement announced • Spectranetics CEO, VP and Manager – And, external company hired by Spectranetics • Stryker sales reps – Back door into company DOJ’s 2011 goal is 90% of investigations “favorably resolved”
- 19. Recent CIAs Point the Way • Tracking database – Substantive requirements – e.g., VT law • RAMP – “First-class software blessed by HHS”, Giampetruzzi • Monitoring triggers – e.g., high volume of purportedly unsolicited requests • Practical Compliance Advice: Recent CIAs – www.prolifiq.net/lifesciences – www.ebglaw.com in articles section
- 20. Speed of Light • Real-time search engines – Google Instant – Collecta – 1 second lag scanning social media sites, blogs and web • Lightning fast action/crisis response plans – During Domino’s 2 day lag, nearly one million people viewed the videos on YouTube
- 21. Poll Question • Is social media review, e.g. Facebook posts, tweets and LinkedIn group discussions part of your company’s current Promotional Review SOPs? – Yes, and it is adequate – Yes, and we need to revise – No – Working on it – Don’t know
- 22. PACE: A Four-Step Process Elsa Chi Abruzzo President, ARAC, LLC (20 min)
- 23. What is PACE? Prepare Analyze Categorize Execute
- 24. Prepare 1. Obtain cross-functional executive approval 2. Establish cross-functional content review committee – Strategic Governance Structure with CCO Oversight and/or, Tactical Cross-Functional PRC – SOP with objective criteria with approval form containing how and where this will be used – Regularly scheduled meetings 3. Broaden purview to increase branding and compliance – Solicit materials for review, including at the concept stage – Convince company employees broadly to submit materials for review Prepare Analyze Categorize Execute
- 25. Promotional Review Committee • A permanent organizational unit • Composed of executives with approval authority • Adopt a content life cycle approach, with oversight from concept through execution • Apply systematic approach Recommendation #2: Create a PRC to align the organization and support execution
- 26. Poll Question • Does your company have a cross- functional review committee(s) with regular team meetings to review and discuss promotional content? – Yes – No – Working on it – Don’t know
- 27. Analyze 1. What are claims made 2. Compare claims against marketing standards book – time basis for updating 3. Which indications allowed 4. Geographical rule sets – Federal/OUS, State, Local/Hospital or OUS: EU, Pac Rim, LA 5. Company Guidelines 6. Ethical/Public Opinion: Fair balance, transparency Assume rapid dissemination to competitors, FDA et al. Prepare Analyze Categorize Execute
- 28. Primary Filters 1. Must be truthful and non-deceptive 2. Must have evidence to back up claims 3. Cannot be unfair 4. Risk Communication Guidance 5. Fair and balanced 6. Transparency
- 29. Categorize 1. Associate material with appropriate category a. 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) b. Include categorization in PRC form, SOP and final approved material code c. Category is approved along with the material 2. Category drives rules = Consistency a. Disclaimers, risks, indications, approved labeling b. Author and study funding disclosures for reprints c. Approval routing for review of clinical trial content d. Data collection for unapproved use reprint requests Prepare Analyze Categorize Execute
- 30. Today’s Business Environment • On vs. off-label is complicated – Indications + Claims – Physicians choose use – Industry must find non-burdensome way to responsibly provide information • Off-label physician use – AF, Ortho/Bone protein, Peds – Requires industry cross-functional rigor and control
- 31. Poll Question • There are many ways to disseminate scientific materials legally in the US. Is your company using the FDA Good Reprint Practices guidance for any dissemination? – Yes – No – Working on it – Don’t know
- 32. Execute 1. Educate and train across and up and down a. Document training and certification 2. Audit and monitor sales behavior a. Regulations, CIAs 3. Monitor customer usage and close-loop learning to improve materials 4. Listen, modify and repeat Prepare Analyze Categorize Execute
- 33. Controlled Dissemination • Manual fulfillment – frequent updates? – Annual training – will they remember? – Medical Affairs – low on resources? • Intranet – how often do reps log in? • Digital CMS – Make the complex simple with technology – Efficiency and cost-savings with processes – Two choices • Modify non industry-specific with compliance rules • Choose industry-specific with compliance rules
- 34. Real-Time Monitoring • Retrieve quickly • Confident • Comprehensive • Pinpoint individuals, recipients, geography, products Competition, FDA or other external inquiries Rx Compliance Report, Vol. VIII, Issue 7/May 5, 2009
- 35. Promotional Communication SOPs (10 min)
- 36. Continuous Learning SOPs Laws Risk Communication Manifestation Interpretation “Permanently affixed” in Sales Environment GRP Enforcement CIAs/DPAs
- 37. Short List • Promotional review – Committee – Sign off form – Repository – Change control – Where stored • Claims references • Signature matrix
- 38. Communications – Promotional, Educational and Scientific How To • Cross-functional review team • Change Control – Promotional Risk Analysis and Mitigation Procedure • Training • Auditing and Monitoring • CAPA – Social media, PR, Facebook, Twitter
- 39. Case Study: Meet H2FMed Company: H2FMED Device: Drizzle infusion catheter Context: US-based tradeshow for interventional radiologists Approvals/Clearances: Class II 510(k) product Indication: Indicated to infuse various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with respective manufacturer's instructions for use.
- 40. Case Study: Tradeshow Preparation (10 min)
- 41. Holistic Review: Net Impression
- 42. Tradeshow Plan • Pre-meeting emails/mailings • Non-CME Symposium • Booth – Videos and Graphics – At-show collateral and emails – New Products Uncleared • Collateral, print and digital • Door drops • Post-show follow emails • Advisory Board/KOL meetings • Scientific Posters • Sponsorships • Sales product training for booth duty • Training materials
- 43. Final Approval
- 44. Concept to Launch Review
- 45. Post Approval Considerations • Training the sales force • Build compliance into sales processes • Validate that approved content is properly managed • PRC retains visibility to use of content – Communications History Records
- 46. Questions & Answers • Elsa Chi Abruzzo, President/CEO, ARAC LLC – abruzzorac@gmail.com • Maureen Shaffer, President/CEO Mingletoe LLC – maureen.shaffer@gmail.com – http://www.linkedin.com/in/maureenashaffer – http://twitter.com/maureenshaffer
- 47. Takeaways • Downloadable presentation with audio available for a fee – raps.org • Practical CIA Takeaways – www.goodpromotionalpractices.com
- 48. Thank You Please complete a webcast evaluation located online at the link below. http://research.zarca.com/k/SsTTXYsS QXsPsPsP
Editor's Notes
- RAPS: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 15 minutes for questions and answers at the end.Next slide.
- RAPS:First, housekeeping. During this call the audience will be muted to minimize distractions. Please however feel free to submit questions via [conference software] during the call. At the end of the call, questions will be taken. Also, a recorded version of the webinar will be available following the session at www.raps.orgNext slide.
- RAPS:Today’s speakers have extensive experience in creating, implementing and monitoring promotional content review in medical device companies, and they are excited to join us today to share some real-world advice.Elsa Abruzzo is President of the regulatory consulting firm, ARAC LLC, and has 20+ years of successful regulatory, quality, and clinical experience with innovative medical devices and disruptive biotechnologies, including embolic agents, stents, biomaterials, active implantables, and percutaneous heart valves. Elsa has worked at companies such as Baxter, Cordis Johnson and Johnson, CryoLife, Percutaneous Valve Technologies, AtriCure, InnerPulse, and Merlin MD. She designed, developed and executed U.S. and international clinical trials, including Bayesian adaptive designs and break-through first-in-man studies. Elsa’s regulatory strategies have resulted in worldwide commercialization of products. Her clients, primarily startup and emerging growth companies, span the globe and a variety of medical disciplines. Elsa is Regulatory Affairs Certified and a RAPS Fellow for the Class of 2010 and has a BS in Engineering from the University of Miami. Maureen Shaffer is the VP of Life Sciences for Prolifiq Software and has 20 years of global marketing experience. She has created and driven game-changing strategies, products and teams at VC-backed startup, emerging growth and multibillion dollar medical device companies. Maureen began her career launching Cordis’ first PTCA balloon catheter and more recently built and led the marketing team at AtriCure where they grew from $9M in revenues to $50M. She has also worked at innovative companies such as US Surgical, Heartport and Converge and launched more than 100 innovative products. Maureen recently jumped into the software space with Prolifiq to develop mobile fulfillment solutions for the increasingly complex challenge of sales and marketing in medical device, pharmaceutical and biotech companies. Maureen has a BS in Biomedical Engineering from Duke University.As a point of disclosure, Maureen is the managing editor of goodpromotionalpractices.com for which Prolifiq is one of the sponsors, and Elsa is a regularly contributing blogger on the site.With that I’ll turn it over to Maureen who will begin our presentation.Next slide.
- Maureen:Thank you Jennifer. Good morning everyone, my name is Maureen Shaffer. Thank you very much for taking the time to participate in the Best Practices for Promotional Content Review webinar today. And, as Jennifer stated, Elsa and I welcome your questions and your input throughout our talk and look forward to addressing them at the end of our talk today. While many of the tools and principles we will outline are derived from our experience in medical devices, they are broadly applicable to pharma, dx and biologics as well. Lastly, if there are references or articles mentioned during the presentation that you would like, make a note of it and please feel free to reach out to us via email or on goodpromotionalpractices.com.So, before we dive into the how-to of this webinar with Elsa, let’s first spend 15 minutes talkingabout what GPP is and why GPP is critical now in order to frame our how-to discussion and case study.
- Maureen:GPP. GPP stands for Good Promotional Practices – the best practices for medical device, diagnostic, pharmaceutical and biotech companies to promote and provide information to their customers and patients about their products and the procedures and disease states that surround them. We have all heard the quote, “those who cannot remember the past are condemned to repeat it.” Well, we learned decades ago with GMPs that inspecting out quality at the end of a manufacturing process is less effective than building quality into the process. However, we are currently facing numerous quality control issues with promotional and non-promotional materials, and the DOJ, FDA, SEC and other regulatory bodies are currently using their enforcement efforts to inspect it out. We already know the solution -- we need to build quality into, as part and parcel of, our promotional processes.We already know how important design controls are to apply solid principles of design to medical devices, GMP is to quality output and human factors are to proper and safe usage. Now we need to apply these principles and understanding to the creation and dissemination of promotional and other customer-facing content to protect your company, your sales people and, most critically, to protect physicians and patients.
- Maureen:Step one. The first step in GPP for Promotional Content Review is to apply some of the best principles of design controls to systematic content creation. What you see on the left side of the slide are basic tenets of design control – no mystery to anyone in this webinar. And, on the right side are the analogous best practices for systematic content creation. First, start with the end in mind. A project brief. At a minimum, it should include what you are trying to accomplish, for whom, and within what parameters such as time and budget you are trying to accomplish them.Secondly, the content creation cycle starts when the project brief is completed – at the concept stage – not when, as I am sure many of you have encountered, when Marketing has a brochure designed and wants your approval to print it tomorrow.http://www.slideshare.net/truedigital/how-to-write-a-creative-brief-by-true-digitalStaged project reviews by a cross-functional team are also best practices for content creation. And, a risk analysis equivalent to risk analysis in design controls is crucial to uncover potential issues ahead of time, e.g. what if this material is combined with this other material, such as a disease awareness brochure with a procedural video? What if this collateral was given to a specialty for which there is no indication? You may want to consider different elements of externally-facing risk, such as reputational, human risk and financial risk. Preventative measures are of course part of your risk analysis and correlate to assessed level of reasonable risk.
- Maureen:Step 2. Step 2 in GPP for Promotional Content Review is to marry the best of GMP to Systematic Content Control. Procedures for Content control might include…Internal and field procedures – you may think they should be the same but the working environment of a sales rep, for example, is quite different than employees who work in house so while they may be part of the same SOP, the manifestation should be quite different.Akin to a DHR, a content or communications history record captures the life cycle of the content from project brief to customer delivery.There is traceability and change control mechanisms for updating or obsoleting content globally.The training of global field sales personnel requires a different approach than training production workers. More on that in a minute.And, while CAPA is the gold standard, RAMP, or Risk Analysis and Mitigation Plan, is an extension of standard risk analysis with periodic polling and surveying similar to SEC disclosure checklists to uncover areas of potential concern and focus. It is worth taking a few minutes and reading Appendix C of Pfizer’s CIA which talks about their RAMP system. And, while they use it more as an overarching tool for safety/product liability, healthcare law,Compliance as well as advertising and promotion issues including the risk of off-label promotion, it has useful considerations for crafting your promotional RA and mitigation plan.Next slide please.
- Maureen:Step three is the consideration of Human Factors to Promotional Content Review. The FDA defines human factors:Easier and safer. Translated to our topic, What can we do to make it easier and safer for sales and marketing to do the right thing?Then they talk about clinical and home settings. Well, what have we done to consider the daily lives of sales and marketing and their environments?Then, “the identification and investigation of use-related errors”. Use-related errors. What if we assumed that sales and marketing were in fact, use-related errors. If we assume that sales and marketing wants to do the right thing, then how would we change our approach to content review, approval, training and dissemination?Let’s talk for a minute about environment and personas.FDA’s definition of human factorshttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/HumanFactors/default.htm
- Maureen:Environment. The HBR Management Tip of the Day on April 20th, 2009 hit home with me. It was titled, “Forget Compliance. Think Environment.” A somewhat outrageous and scandalous statement. But, bear with me. Let’s review what the FDA says further about Human Factors. If we were to rewrite this to consider the use of content by sales or our customers, which of course is the entire point of promotional content creation and review, it might read like this [page down for animation].So, ifPeter Bregman at HBR is right and “Your environment dictates your actions.” What environment are we creating for our sales force to be compliant? Is it intuitive? Easy? Does it consider how they work? Just like marketing considers physicians and patients their target audience, have you ever considered sales, or even marketing, your target audience – studied them, asked them how they work and what would make it easier? If not, now might be a good time to start.Do It By Design, an Introduction to Human Factors. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095061.pdfTitled borrowed from HBR Management Tip of the Day. http://web.hbr.org/email/archive/managementtip.php?date=042009Adapted from:http://blogs.hbr.org/bregman/2009/03/the-easiest-way-to.html?cm_mmc=npv-_-MANAGEMENT_TIP-_-APRIL_2009-_-MTOD0420&cm_mmc=npv-_-MANAGEMENT_TIP-_-APRIL_2009-_-MTOD0420
- Maureen:Finally, I spent 20 years influencing sales to adopt marketing messages and technology. The most important thing you can do is to understand their daily habits. Personas can be a powerful way to begin the human factors process. They are more widely used in software than in LS companies, but can be powerful to coalesce disparate understandings of how sales operates. For example, sales tends to be a very verbal and mobile-oriented group. We want them face to face with the growing group of constituents to whom we sell as we see here in the lower right, not writing impressive tomes or reading copious amounts of written materials, correct?So, I will leave you with one question to close this section. If we “forget compliance. think environment”, how would you redesign promotional content creation and control to ideally meet both internal needs as well as the needs of a highly verbal, on-the-go, in the car, let’s say standing at the scrub sink sales group?[Additionally, Marketing is trying to respond more rapidly to more non-physician constituents than ever before and, in many cases, with this economy and healthcare reform, with less resources. I would maintain that you need to consider a promotional content review system that meets the individual needs of each member of this cross-functional group: regulatory, medical, legal, sales and marketing.]
- Maureen:Here is the first of our four poll questions. We will give everyone a minute to respond.Okay, so that’s [fascinating/as expected/unexpected]. Clearly, we [do a great job/need to do better/can learn that we have a gap].So, as we spend a quick 5 minutes reviewing [criticality/PACE/SOPs/tradeshow case study], let’s keep in mind that…[one salient point].
- Maureen:Now that we understand that GPP is really a combination of best practices of Design Control, GMP and Human Factors applied to promotional labeling creation and control, I want to provide some fuel for you to bring urgency about refining and expanding your current promotional, educational and scientific review systems.
- Maureen:The court of public opinion has voted. And, we have lost by a wide margin. Harris Interactive conducted a poll at the end of 2009 of more than 2000 (2,303) adults in US. And, Pharma, into which I think consumers lump all medical device, dx and biotechs, gave us a 9% honesty rating. In other words, according to the question asked in this survey, “generally honest and trustworthy – so that you normally believe a statement I hear from a company in that industry”. We got 9% -- wedged between telephone companies and car salespeople. In comparison, 36% believe supermarkets are honest. Supermarkets. And, we are selling life saving, health-creating, QOL-extending drugs and devices. Not surprisingly, they gave pharma the number 2 spot for needing more regulation in the very same study, just below oil companies. We can certainly do better.
- Maureen:You all are already experts in regulatory law and know that laws have been proliferating beyond federal boundaries, growing more detailed and they are starting to consider med device, pharma and biotech as equals, such as in the Risk Communication Guidance, Good Reprints guidance as well as in VT and other state codes of conduct.
- Maureen:Why do we need GPP now, I think these data speak for themselves. In 2009, nearly 600 convictions to the net tune of $1.6B. Combined, almost 2000 NEW criminal and civil healthcare fraud investigations. Looking forward, in 2011, DOJ has a performance goal of having 90 percent of cases favorably resolved. With this math, they would double plus their number of settlements.Backup2011 budget:During 2009, the government opened 1,014 new criminal healthcare fraud investigations concerning 1,786 potential defendants. The government obtained 583 convictions for healthcare fraud. It also commenced 886 civil healthcare fraud investigations. During the year, the government won or negotiated approximately $1.63 billion in judgments or settlements. To fund these efforts, the government allocated some $465 million in funds to HHS and DOJ, with the Office of the Inspector General receiving approximately $196 million. Last year, HHS and DOJ created the Health Care Fraud Prevention and Enforcement Action Team, or "HEAT," a joint enforcement initiative designed to combat Medicare fraud. HEAT has "Medicare Strike Forces" in four U.S. cities--Miami, Los Angeles, Detroit and Houston. These Strike Forces analyze billing information submitted to Medicare for irregularities. The government has forced large pharmaceutical manufacturers into civil and criminal settlements for alleged unlawful promotion or marketing of drugs. Notable settlements in this area include Pfizer, Inc., which, at $2.3 billion, constitutes the largest healthcare fraud settlement in U.S. history, Eli Lilly Company; Abbott Laboratories, Inc.; and Bayer Healthcare, LLC.In 2011, DOJ has performance goal of having 90 percent of cases favorably resolved.CDRH's promotional compliance staff increase from 1 to 3 announced last week still pales in comparison to that of FDA's drug center, which employs nearly five dozen. However, while the Center for Drug Evaluation and Research must review television ads for pharmaceutical campaigns before they air, CDRH does not have similar requirements for device ads.Next slide please.
- Maureen:Additionally, the DOJ has pledged to utilize FBI techniques to combat medical fraud and abuse. In particular, Lanny Breuer, Assistant Attorney General for Criminal Division of the DOJ, speaking during the American Bar Association National Institute on White Collar Crime meeting said:“We also are striving to innovate in how we do business. That could mean utilizing data and intelligence more strategically, or it could mean – as we've seen in a couple of prominent cases recently – going undercover. However we do it, we will be more targeted, more creative, and more strategic in where and how we look for criminal conduct.”If the DOJ is innovating and are being more targeted, creative and strategic, we need to do that and more to get ahead of the curve and protect our companies and employees.Backup: “We are especially concerned about increased disparity in white-collar sentencing. It is not uncommon for a health care fraud defendant to be sentenced to 15 or more years in one district court, while, in the same week, another defendant in another court involved in a larger fraud is sentenced to a very short prison term.”
- Maureen:Individual liability is being taken to new levels. The FDA has announced that they are revamping their criminal prosecution department to increase prosecutions of Life Science executives and managers. In a letter to Sen. Chuck Grassley (R., Iowa), the FDA says an internal committee has recommended that the FDA and its Office of Criminal Investigations "increase the appropriate use of misdemeanor prosecutions, which allows responsible corporate officials to be held accountable and is a valuable enforcement tool.“We see some examples here, but the most interesting is the new Allergan Board suit where two days on the heels of reaching a settlement with HHS, the police retirement fund in Baton Rouge LA sued Allergan’s board for willful approval of illegal sales and demanded not only the board take personal financial responsibility to pay the $600M judgment so that it did not affect their pension fund, but in fact, demanded that the CEO return part of his compensation earned from illegal sales.Backup:More FBI, More DOJ attorneys, SEC, FDAThe government has forced large pharmaceutical manufacturers into civil and criminal settlements for alleged unlawful promotion or marketing of drugs. Notable settlements in this area include Pfizer, Inc., which, at $2.3 billion, constitutes the largest healthcare fraud settlement in U.S. history, Eli Lilly Company; Abbott Laboratories, Inc.; and Bayer Healthcare, LLC.Last week, Allergan agreed to pay $375 million and plead guilty to one misdemeanor count of misbranding in connection with off-label marketing of its Botox med for various unapproved uses – headache, pain, spasticity and juvenile cerebral palsy – between 2000 and 2005. Another $225 million will be paid to in fines to cover civil claims asserted by the DOJ under the False Claims Act – there were three separate whistleblower lawsuits filed by Allergan employees that prompted the government probe (background and documents here).Essentially, the pension plan argues Allergan board oversaw a calculated strategy to boost sales illegally and either willfully approved the effort or shirked their responsbilities.Allergan chairman and ceo David Pyott was also named as a defendant and, since he benefited from increased sales, the suit claims he should be forced to return part of his compensation. In 2011, DOJ has performance goal of having 90 percent of cases favorably resolved.
- Maureen:I encourage you to googlehhs and cia and click on the cia list link. HHS is giving you a sneak preview of their expectations. A once a month review would be enlightening. Additionally, Epstein Becker & Green penned a great paper on Practical Compliance Advice which you can find on their site, prolifiq’s site or goodpromotionalpractices.com.Backup: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. Epstein Becker and Green has WRITTEN A HIGH-LEVEL ARTICLE TOUCHING ON THESE CONCEPTS, AND IT isE AVAILABLE ON THE PROLIFIQ WEBSITE AND EBG’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. Next slide.
- Maureen:To close on the criticality of now for revamping your promotional content and control procedures, let’s talk real-time search engines and social media. These real-time search engines have a 1 second lag. 1 second – the noun lag hardly seems appropriate. What is your company’s monitoring lag time for the stream of news, blogs, social media and the web communications that may or may not be disseminated appropriately? If you are relying on training, consider Reagen’s adage, “trust, but verify”. You don’t want one million people viewing an off-the-reservation video, having the NYT pick it up as a story and having it cut, re-worked, and re-posted hundreds of times the b/c it takes two days, like it did with Dominos earlier this year, to formulate an action plan.Backup:Domino’s learned firsthand the power of social media after two Domino’s Pizza employees posted videos of themselves doing disgusting things to food that they were getting ready to send out. The results were catastrophic due in large part to Domino’s waiting two days to respond. During their delay nearly one million people viewed the videos on YouTube and simultaneously blogs, forums and Twitter were ablaze with discussion of the incident. The company responded by firing the two employees and issuing an apology via YouTube. According to the New York Times, the damage was already done as consumer perception of the brand turned negative within hours and online forums continued to discuss the videos, which were cut, re-worked, and re-posted hundreds of times, long after the apology was issued.You need to consider social media as part of your promotional content review procedure.And, now Elsa Abruzzo will discuss how to work and respond effectively in this newly demanding environment.Next slide please.
- Elsa:Thanks Maureen and thank you for taking the time to listen in today. Maureen just covered a lot of ground and explored some very current, but scary topics for the compliance folks in the audience, especially. Top on the scary, but current list is the issue of Social Media, which brings up a very interesting poll question for the audience… please take the time now to answer if “social media review. For example Facebook posts, tweets, and Linkedin group discussion are part of your company’s current Promotional Review SOPs?” IF yes please answer if you think you cover this topic adequately or whether it needs some revision/upgrading…Let’s wait moment for the results (Jennifer…)… Ok… well it seems that the audience answered …(Read results… more than half or most responded that )…Well we will try to cover some aspects of Social Media Promotional Content review in this webinar, but this is a quickly evolving landscape and do it any real justice would require another whole webinar devoted to just the subject of social media (and I believe there are such animals)… Also, as Maureen will point out later… a group of us recently established a website with blog posts and video that delves into GPP issues and I specifically cover the Social Media Beast in my inaugural Blog post… (Next Slide)
- Elsa:Ok, … next we will be covering a process that we developed in part at a former employer of Maureen’s and mine, where we were dealing in a complex regulatory landscape. This process has been further developed with time and collaboration from my legal and marketing colleagues. Today, we will be addressing the dissemination of tangible and digital materials with a nod to oral dissemination and social media, but the former will be our focus. As Maureen alluded – similarly to GMPs we believe that for GPPs, a systematic, regular, and continuous review program with feedback assessment is critical to creating a GPP PLAN that not only keeps you compliant and out some of the troubles Maureen described so vividly, but that is also efficient, effective and timely in providing your internal and external customers with the promotional materials that will convey your relevant and intended communications. (Next slide)
- Elsa:To this end, 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. 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 Communication or Content History Record or CHR, which will help you and your company in a worse-case scenario (some previously described by my Marketing colleague).… We’ve used PACE in a variety of very complicated regulatory situation and it works. Today, we will introduce the PACE process , but for the sake of time can only give an executive overview of how you can apply pace to promotional materials … How PACE can address other types of information such as dissemination of scientific information/articles will not be covered in detail in this particular webinar. However, we hope that between the GPP Blog, subsequent webinars, and other sources through RAPS that we will be able to covers these very relevant topics with more clarity. (Next slide)
- The first step in PACE is Prepare. There are three key sub-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 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. And now with social media lurking to make your PRC activities more difficult… one a week could be considered a minimum. 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 (the efficiency and effectiveness that I mentioned earlier). However, this is something that will initially require education and encouragement. It will not necessarily happen overnight (like regulatory approvals or product development… )Next slide.
- Elsa:Regardless of the type of information being reviewed, the crux of a successful GPP system and PACE for that matter, is establishing the Promotional Review Committee. Throughout my career, I’ve seen companies take a variety of approaches to organizing for review and approval of promotional content. The most effective approach that I’ve seen can be characterized under the idea of a Promotional Review Committee or PRC. These groups may have different monikers, but there are some commonalities that the most effective ones share. One … the group should be ongoing—not just formed to review initial materials and then disbanded. It should have regularly scheduled meetings (weekly or biweekly, depending on the volume of material anticipated or already in-market). While there may be occasions when a product marketing manager would need to convene an “emergency” meeting in a hallway to obtain quick review and approval, these adhoc meetings should be rare. The discipline brought about by naming a standing group helps to establish clear ownership, and continuity that others in the organization can understand and rely on. Two … The group should be composed of executives with approval authority for their function and who are well versed in the regulatory and compliance landscape. This promotes efficiency by avoiding extra-committee meetings with other individuals who would not have the elsaefit of the group discussion. It should include members from -- sales, compliance, legal, quality assurance, and perhaps, a clinical representative – all of whom can advocate for their functional area, while maintaining a balanced cross functional view.Three … the PRC should review all scientific, educational, and promotional content used in outbound communications, including: sales presentations, product literature, advertisements, web site content, product videos, and so on. The reviews should occur early in the concept stage – to avoid unnecessary expenditures that occur later in the production cycle, and their oversight should extend all the way through the execution phase, where new, and perhaps unexpected risks, can be introduced.And finally, the PRC should employ a systematic approach to carrying out their task. The elsaefits of adopting a regimented approach to developing promotional materials accrue across the company. Marketing managers know what information they need to present in the review and approval process and when to present materials. Committee members understand what they are charged with and when they are expected to be available. Salespeople know where to find information about audience and usage. In short, it is an efficient, reinforcing cycle.(Next Slide)
- Elsa:At this point it may be interesting to see what how many of the companies in the audience have a cross-functional review committee or committees with regular team meetings to review and discuss promotional content? Let’s take a moment to vote and wait for the results…Jennifer…the envelope please…OK, it seems that _________ of the audience responded that they do have a PRC vs. ____ that don’t and ___ that are working on it or don’t know…(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. Fair and balanced does apply to medical devices, particularly in the court of public opinion where mentally devices with pharma are group together, and as you will hear during the next slide even FDA has made it clear that it has similar expectations of medical devices when it comes to promotional labeling.Lastly, with the proliferation of the internet, email and social media, we shouldpresume that every document will be in hands of competitors, FDA, patients and lawyers within days of approval (or if you don’t have a good system when days of the non-sanctioned communication that you failed to stop – such as the Domino YouTube video Maureen mentioned). Thus, we need to balance this with assuming that if it is extremely important, consider if there is a compliant way to give them what they need in an effective and timely (now a days even real time) fashion to prevent any desire to circumvent the system. Remember, people are resourceful – so try to be helpful within the appropriate boundaries.(Next slide)
- It is helpful to filter your promotional content review through a high level set of filters that give their assessment some structure and ensure proper coverage of all potential issues. It’s important to note that content that falls into the other major categories of the PACE process, including scientific and clinical, have their own set of filters that would be applied.Item #4, the Risk Communication Guidance filter, has particular applicability for content that will be used in the trade show environment. FDA’s Guidance for Industry “Presenting Risk Information in Prescription and Drug and Medical Device Promotion” issue May 2009 is a great reference --- become familiar with this guidance – you may wish to incorporate sections of it into your relevant GPP SOPs or at least reference this document.The guidance covers advertisement and promotional labeling for prescription devices with respect to the disclosure of risk information so that risk and benefit information are presented accurately, comparably in a prominent manner, location, and type and a non-misleading way to the target audience (health professionals and consumers – specific patient populations). Although the guidance does not cover OTC drug promotional labeling… FDA makes it clear in the document they do regulated this separately. The guidance is very usable and can help establish a good foundation for your PRC reviews. We all know that promotional materials cannot be false or misleading and must reveal material facts about the product including risks, but FDA goes through great length in 24 pages to specifically help industry understand their position. In the guidance FDA emphasize the “Net Impression” or message communicated by the piece conveys as a whole and includes many examples for each of the filters they list for review of promotional labeling. With “Net Impression” FDA is following well-developed social principles used by the Federal Trade Commission to determine whether the piece overall is misleading and to do this is uses “reasonable consumer standard” approach – examining the piece from the “perspective of a consumer (what ever the consumer is – such a aa particular health professional or patient population) acting reasonably in the circumstances”. This approach does not preclude multiple interpretations of a claim so long as they are reasonable. FDA will take into account expertise of the lay consumer and the trained healthcare professional. FDA is also very aware for the purposes of “Net Impression” that “cognitive science research has demonstrated that all people, regardless or expertise, are only able to think through and process a limited amount of information at one time. This principle guides some of the filters they discuss in detail throughout the document. We don’t have time to go into a detailed review of the guidance and its many wonderful review filters, but here are just a few of the general considerations:Use of consistent language for target audience – to balance how risk and benefit information is conveyed – for example using friendly language for claims and then the word “syncope” instead of “fainting” for the risks.Use of signals – how text is emphasized should be balanced (e.g. use of headings vs. subheadings, bolding, etc.) -- in this case the content is also important – for example using the heading “Important Risk Information about Device X” is preferable to “important Information about Device X”… yes FDA is delving deep into how they will review your promotional pieces so you have to be as detailed in your reviews.Framing Risk Information – or how a particular piece of information is stated or conveyed by emphasizing positive or negative information in vague versus specific terms that may make the presentation of risk/benefit information unbalanced or minimize the risk. For example referring to your brand name for benefits and the generic name of the drug for your risks…Hierarchy of Risk Information – where it appears on a piece… FDA does not want the risk information buried on the bottom of page 8 brochure … Memory research consistently shows that people are better able to recall the beginning and the end of a list than the middle… however, first in line still has more prominence… also ordering the risks in a way that can mislead falls under this filter – for example stating drowsiness as a side effect after you state that patients should not drink alcohol when taking the drug – patients might associate the drowsiness with the alcohol use (adjunctively) rather than just a side effect of the drug itself regardless.The guidance goes on to cover content considerations, format considerations (which include print promotion as well as non-print promotion such as videos, broadcast ads, and similar audio and visual pieces). FDA even discussed the use of text that is superimposed on other images in video or broadcast ads termed (SUPERs)… and gives a whole host of considerations for how SUPERS may be best used to convey the proper “Net Impression”. Finally FDA concludes with the statutory requirements of the Law and makes it clear that although FDA does not review 510 (k) promotional pieces as they do for PMA products, that these must also comply with the law and recommendations in the guidances will be applied to their review.Next slide.
- A good example that FDA is applying their own guidance is the recent (6/22/2010) letter to Shire regarding their ADHD drug Intuniv (guanfacine)… in the 6 page faxed letter – FDA goes into painstaking detail of how Shire violates many of the considerations and principals espoused in the Risk Information Guidance we just reviewed. Shire is cited with presenting unsubstantiated superiority claims and effectiveness claims and omitting and minimizing important risk information thus resulting in promotional materials that they consider false or misleading and thus under the FD&C Law misbrand the drug. The letter provides great insight into how FDA’s PRC reviewed the Shire promotional labeling pieces which included a Parent’s Guide, Support Guide, In-Office Waiting Room Brochure, Titration Guide, etc. >>>>>>>>Well… we have now reviewed the first two steps of PACE – Prepare and Analyze. Step Three is Categorize. … 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. When addressing Social Media… you may need a separate set of filters and categories…possibly by the type of social site being covered – LinkedIn versus Facebook vs. Twitter… In fact defining what Social Media avenues will be used officially by the company for promotional purposes, what departments/personnel are allowed to officially post for the company and what material can be posted … should be part of your GPP Plan, SOPs, and hence you CHR. With the advent of new social media sites, this will truly require you SOPs/systems to evolve and continuously improve… You won’t be able to be reactive let alone be proactive without a regular review and update of your systems. The key to Social Media GPP compliance activities will be to demonstrate differentiation between company sanctioned/official usage and unofficial personal use by your employees. Thus this topic possibly extends even beyond your CCO responsibilities and into the HR and employee policy handbook purview. This would be similar to how you might control email communications. In our Blog and other webinars we will explore tools to review, authorize, and control social media content for promotional use that extends PACE to a higher level. Monitoring on a regular basis as explained previously will be key to this topic. Also, identifiers on posts (such as that use by Twitter – like the in# at the end of a Tweet to only link those identified Tweets back to your LinkedIn posts) and other more evolved and customized tools that are or may be available in the near future to further real time social media content GPP compliance.But back to our more conventional promotional content application of PACE and our third step in the process… 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:Audience for this webinar understands the difference between on and off-label.. However, even for seasoned professional is not always black and white… really it is not as simple as it seems as some of your regulatory folks can attest evidence by the existence of multiple sessions on this topics at last years and this years RAPS Annual Conference and a plethora of other meetings and educational/society sites. So you are not alone.We all know of multitude of scenarios that can be encountered… and rules that apply. We often rely on the fact the FDA cannot control the practice of medicine (well they don’t have the legal jurisdiction to do so) and that physicians may choose to use the device in a manner that may not coincided with your approved labeling/intended use. However, how you inform that physician and promote your device is your responsibility and under FDA’s review and enforcement purview. So you need to facilitate exchange of scientific information responsibly and in compliance with those dissemination rules. Allowable methodologies for dissemination/safe harbors are complicated and can as easily be legal as be violative. This can become very complicated, very quickly… particularly a the broadband and 4G lightning speeds of internet and social media… and increases the complexity of control for Legal, Regulatory, Marketing, Sales etc.(Next slide)
- Elsa:With this in mind, how many of you are using the FDA Good Reprint Practices Guidances at you company?…please vote now…Ok… well it seems that most of you know about this and are using it… goodORHaven’t really adopted or had to adopt the use of this guidance… however, you should become familiar with it if you company is one that relies heavily on the dissemination of scientific information to your healthcare professional customers…
- Elsa:Step Four of PACE: Is Execute.Execution, which includes a strong educational/training component, 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.Having personally gone through an FDA for cause inspection and involved with answering FDA letters generated by competitors’ complaints or so called “inquiries”, having a system that documents your compliance philosophies and conveys your companies policies to realize them will be key with FDA. You can’t defend your position if you don’t really have one!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 familiar 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.
- Elsa: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.
- Maureen:First, a framework for SOPs. Our standard operating policies and procedures need to be based on four building blocks. First, the laws and guidances such as the Risk Communication guidance Elsa discussed previously. Secondly, the interpretation of the laws which may change over time. For example, what is the intent and the meaning of “permanently affixed” in the Good Reprints Practice guidance?Thirdly, enforcement actions such as CIAs and DPAs give us clues as to the current best breed practices surrounding the enacted laws and guidances.Lastly, manifestation. How do you manifest the laws, their interpretation or intent, and evolving enforcement trends into your culture and environment. No one would argue that stapling constitutes permanently affixed, but if the reprint and its necessary attachments create one inch of paper, is shrink wrapping permanently affixed? What about a binder clip? And, how would you manifest “permanently affixed” in a digital environment with sales? And, how do you stay abreast of all of these moving parts over time and evolve?Elsa.
- Not to design an SOP for regulatorySustainable, trainable, usable all the way through to field staff dailySalient tipsFollow more important.LinkedIn groups, CafePharma tied to the company. Yahoo Finance anonymous/aliases.Documentation of training, authorization and authority – free range within boundaries with periodic audits, quagmire, otherwise PRC spends all day reviewing and approving communications. CAPA for promotional, educational and scientific materials? Have to be able to compete. How effective is social media with physicians? Patients?Field sales force monitoring: The Pfizer agreement broadens the oversight of its field sales force, requiring, for example, attorneys to conduct ride-alongs with sales representatives to assess their compliance. Speaker monitoring program: In addition to a field sales force monitoring program required in other CIAs, Pfizer’s requires it to implement a program to monitor speakersThe scope of “promotional and product review functions” has been extended to include both Pfizer’s Medical Information Department (often called “Medical Affairs” in other companies), and R&D and publication activities, including post-marketing work. Audit committee and executive compliance certification - requiring the Board of Directors’ Audit Committee and certain executives to certify compliance is a common OIG-HHS demand recently; Pfizer has agreed to it in this CIA. Off-label requirements - the CIA expressly requires Pfizer sales reps to refer off-label inquiries to Pfizer’s Medical Information Department. Prior pharma CIAs typically described compliance obligations more broadly. Other compliance requirements are written in much more specific language than in prior CIAs. Outside the scope of this presentation b/c social media is a huge topic, but we have all seen the FDA take enforcement action with multiple companies over Google AdWords ads and lack of proper risk communication. How do you control your blogs, tweets and facebook posting? How do you control the content when it is live, real time and constantly linking and appearing. Style guide and claims reference for all of the social media pieces.Next slide.
- Elsa:H2FMed serves as our fictitious company for today’s walk through of sample promotional materials. The scenarios and samples that you’ll see are based on actual situations, but have been abstracted to allow discussion of issues while respecting the confidential nature of the content.To provide some background, H2FMed manufactures and distributes medical devices for interventional radiology, such as catheters and guidewires. As you can see from this slide we’ve also included information of the device in question, in this case the Drizzle infusion catheter, and its cleared indication. They PRC is overseeing the preparations for an upcoming trade show for US-Based interventional radiologists, know as IRC 2010. We will walk through some of those evaluations, and use them as a framework to understand how a PRC operates, and the range of items that they consider in their work. Next slide.
- ElsaWe’ve selected a tradeshow preparation because it covers a broad range of materials as well as situations where the sales force is actively engaged in communications with physicans and other health care professionals.Next slide.
- Maureen:A minimum of six months prior to their appearance at IRC 2010, the Tradeshow Plan review is listed on the PRC’s agenda for their weekly meeting. The Marketing Manager has submitted a formal plan for their appearance that outlines the objectives for the show, as well as all activities and content that H2F Med will bring to bear to meet their goals. It’s important that the PRC sees a plan of this nature so that they can take a holistic view point that will allow them to manage their overall “net impression” as per the FDA’s risk guidance as well as identify all the granular level detail items that need to be reviewed.For one reason why this is important, lookup Shire’s untitled letter which Elsa mentioned earlier. It outlines the issues that DDMAC had with the net impression of a brochure holder, waiting room brochure and parent’s guide.Elsa will now take you through some of the activities and content under the PRC purview that may be reviewed for a tradeshow.
- Maureen:This slide lists various components of the trade show that may involve the use of promotional materials. We reiterate that the PRC should review all of these components in their totality to ensure that the company is conveying the appropriate message about its products at the trade show. We are going to discuss a few of these components in great detail.With respect to a trade show held in conjunction with an unaccredited continuing medical education symposium, the company should ensure that its sales representatives are aware that the symposium, due to its unaccredited status, would be viewed as promotional in nature under existing FDA guidance and therefore would be subject to all rules regarding the dissemination of promotional materials. In addition, the sales representatives should understand other applicable standards regarding interactions with health care professionals, including those embodied in the AdvaMed Code of Ethics regarding the provision of gifts, meals, and entertainment, as well as state laws in Massachusetts and Vermont that severely limit medical device companies’ ability to provide financial support to unaccredited symposia. Under the AdvaMed Code, for example, sales representatives may not take physicians out to dinner.Given these complexities, the multiple sets of standards that apply to trade shows, and the number of gray areas associated with these standards that companies must navigate, the quality and thoroughness of the materials used to train sales representatives and other participants in advance of the trade show assume greater importance. For example, regarding the requirement to promote on-label, sales representatives should not serve as audience “plants” to ask presenters supposedly unsolicited questions about off-label uses, even though it may be entirely appropriate for presenters to answer such questions from other members of the audience. Also, if a physician speaking on behalf of the company declines to answer a question during a presentation, the company should consider in advance the circumstances in which it would be appropriate for a company representative to answer that question from the floor or to follow-up with the questioner individually, as well as who should make that decision and who would answer the question. In addition to training on such legal and regulatory issues, sales representatives should be trained about the company’s products, so that the information they discuss within those legal and regulatory parameters is both truthful and not misleading. We’re now going to take an even deeper dive into two these elements … a product brochure and a video content outline that will be used at the show. Next slide.
- Elsa--Let’s review the pdf of the document <pdf is brought up>The PRC previously did a Concept Review for the brochure … during which they validated the claims made and authorized the build out of more detailed creative layout. During the initial review, they determined that one of the claims was not supportable with data … and it was removed. Catching that in early stages of development saved the marketing group several design cycles, since much of the imagery was going to built around this claim.Today’s review is leading to what the Marketing Manager hopes is a design freeze decision from the PRC, so that she can move to final stages of production. While this brochure contains many examples of issues the PRC would discuss and resolve, for purposes of time today, I will review three. Next page please.elsa--Let’s look at the headline: “Drizzle is preferred for AV thrombolysis by 80% of physicians.” The following are some of the questions that the PRC may consider.First, what is the source of that statement? Is it an internal or independent third-party study or survey? Did the survey include a statistically significant number of patients? What is the appropriate citation to this survey, and where on the brochure should it be included? The answers to these questions underlie the larger question of whether this statement is appropriately substantiated.Second, what types of physicians were surveyed? Are they in specialties that actually treats AV thrombolysis and that use the Drizzle in accordance with its approved label? The answers to these questions underlie the larger question of whether the statement could be appropriately viewed as on-label.Our next concern is the mention of Teflon, here in the body copy. The question here is not necessarily one about promotion. Rather, the question is, has the obtained the appropriate license to use the Teflon trademark and given appropriate attribution? This question demonstrates the need to have a highly coordinated, cross-functional PRC in order to have the requisite subject matter expertise to identify and address legal and regulatory issues of all stripes.ElsaThe third point we are discussing are the pictures at the bottom. The PRC would structure this review with some key questions that relate to the filters previously presented by elsa. For example:Where in the vasculature are the photos taken (does this need to be called out)?Is the implied target anatomy in these photos covered in Drizzle’s cleared indication?The citation below the photos (Courtesy of Dr. Jones, St. Joes, Ocean Grove) implies these photos are from clinical use of the product, so why is there a histology photo included in the set?The two photos showing the before and after of the vessel after thrombolysis appear to be shown in different views/planes, is this correct or can this be misleading? Was the same imaging modality used in the before and after photos? Do we need to put more detailed regarding what was infused, infusion parameters, etc.? Do these photos represent the best result or a reasonable, mean result?There may be good justification and explanations for including all three photos, but additional notes, references or changes may be needed. In this regard, the PRC needs to determine if the brochure is fair and balanced and also if there is transparency. The PRC needs to be very clear about what is being implied.Now let’s move on to our next example, a Video Outline.Next slide.
- Elsa:Constructs to consider to implement your system. Starting off with video. Example of how you would use this process in your newly created SOPs and materials for product launch and tradeshow.The second critical piece of promotional materials to be used at the show is a video, that will be shown on two monitors in the booth, as well as distributed in a follow up email to booth visitors that request additional information. It is especially important that the PRC visit the plans for video and other rich media at the Concept phase. With production costs measured in the tens of thousands, mistakes or risks that perpetuate later in the development cycle can become prohibitively expensive.Let’s review the actual document. <Bring up Video Concept outline word doc> This is an example of a typical, outline format for an initial video concept review.H2FMed’s video for the Drizzle catheter will be a 90-second piece that combines a verbal product description overlayed onto video sequences.Again for purposes of time, we’ll go through 2 examples, but as you can see the PRC would provide notes and comments through out the document.Person 2OK, Let’s scroll down a bit to review the 3rd section in which the audio describes the Slipper coating. It states the coating delivers anti-bacterial protection. Questions for consideration might include the following. What support does the company have for this statement? Did the company perform specific studies to test for the anti-bacterial properties, or is it relying on understood properties of, in this example, silver contained in the Slipper coating? It is important to note that the approved label does not discuss anti-bacterial properties, so the company should be careful not to characterize this as an indication, that is, as a treatment for infection. The company might also evaluate whether the FDA has issued any applicable guidance, perhaps regarding statements about coatings, or whether there were any discussions with the FDA about the anti-bacterial statements.Now Elsa will review another example issue.ElsaAs we scroll down to the 4th section, you will note that during this portion of the video the audience will see an image of the vasculature (including very small/distal vessels) and the catheter wrapped/wound around a pencil (as in the brochure). They will also hear corresponding audio discussing 1:1 torque and tortuous anatomy. Going back to our filters, the PRC would again structure their review of this portion of the video through some key questions… for example:First…With respect to the claim of 1:1 torque—virtually no endovascular catheter has 1:1 torque, so how is H2FMed substantiating this statement? In what scenario did they demonstrate this and was the testing/simulation reasonable and representative of potentially clinical scenarios that could be encountered during on-label use? What catheter configurations and sizes were tested?The PRC may need to add a footnote or citation referencing the supporting testing or otherwise consider removing or changing this claim.Second…The image of the vasculature implies that the catheter can traverse the entire vascular system with no limitations to vessel size or location. Is this supported by the cleared indications for Drizzle? Should the PRC add notes or audio to the video indicating restrictions regarding the size of the vessels and regions that can be reached (maybe the video can reference a minimum vessel size correlating to the smallest Drizzle catheter profile)?Finally…What is implied by the term tortuous anatomy? Is this term too broad or is it a safe claim to make based on the on label indications, testing conducted and provided to FDA, etc.? Again, when reviewing promotional pieces, the PRC must consider the overall net impression, as well the specifics called out in piece. Next slide.
- Maureen:Now that we’ve covered a couple promotional pieces, we move onto the execution phase.The PRC should open room on their agenda if any issues or unexpected risks are encountered at the tradeshow … a timely review will allow for a proper response, and also raise awareness so that the same issue is not repeated in the future. H2FMed’s trade show plan included proper training for all booth staff, and it included instructions on what promotional content could be shared, with whom. The PRC should also ensure that SOPs pertaining to distribution of promotional content are in place and that proper training is conducted for activities beyond trade shows, including physician interactions, especially if new, unapproved or uncleared or investigational products or drugs are shown or discussed. Ideally, the PRC takes it a step further and ensures that compliance is proactively built into sales work flows. Proper content library and delivery solutions can help here. Many companies are also finding that transitioning from print to digital can make it easier to comply with applicable rules.Going digital can also help create communications history records that give the PRC visibility into how content is being used, and make them aware of current compliance patterns and potential new risks.
- RAPS:Thank you Maureen. Now, we move into our Q&A section. We strongly encourage you to ask questions during this section and take advantage of our great speakers experience. To ask a question, [RAPS to explain]Elsa and Maureen:Elsa, Thank you RAPS. Maureen and I will now answer questions. [With 5 minutes to go, RAPS will end question period.]RAPS: Thank you Elsa, Maureen and all the participants on the call for your time today. Last slide please.
- RAPS:Please look for an email from RAPS to all webinar attendees containing [tbd -- a link to this presentation]. And, Prolifiq has graciously provided access to a white paper written by Epstein Becker and Green on the recent CIAs which provide some clues as to future expectations for promotional content dissemination -- a link for downloading will also be included.Thank you again and have a great day.[Jen, save transcript, audio, q&a and anything else that can be saved and close presentation.]