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June 2011

MSL-KOL Engagement: Ensuring Compliance
A FirstWord ExpertViews Report

Doctor’s Guide Publishing Limited does not accept responsibility for any loss incurred by any person who acts or who fails to act as a result of information published in this document. . Any views and opinions expressed by third parties and reproduced in this document are not necessarily the views and opinions of Doctor’s Guide Publishing Limited. No part of this publication may be reproduced or used in any form or by any means graphic. electronic or mechanical.MSL-KOL Engagement: Ensuring Compliance Report Title: MSL-KOL Engagement: Ensuring Compliance Published June 2011 © Copyright 2011 Doctor’s Guide Publishing Limited All rights reserved. This report contains information from numerous sources that Doctor’s Guide Publishing Limited believes to be reliable but for which accuracy cannot be guaranteed. including photocopying. recording. Any views and opinions expressed by individuals and reproduced in this document are not necessarily the views and opinions of their employers. taping or storage in information retrieval systems without the express permission of the publisher.

.................................. 26 Globalisation........................................................................... 2 What do MSLs do? ....................... 23 Clarification ............................................................................................................. 6 US regulations governing MSLs ........ 4 Education versus promotion .. 11 A growing concern......................................................................... All Rights Reserved i ....................................................................................................................... 19 Standard operating procedures..................................................... 1 Evolution of the MSL role............................................................................................................................................. 13 Off-label prescribing ................................................................................ 31 June 2011 All Contents Copyright © 2011 Doctor's Guide Publishing Limited................................... 22 Firewalling............. 9 Off-label marketing cases ............................................................................................................................................................................................................................................................................. 17 Corporate integrity agreements ......................... 15 The clinician’s perspective ................................................................................................................. 30 Tracking and reporting systems................... 28 Frequency of training ..................................................... 8 EU rules on off-label promotion .................MSL-KOL Engagement: Ensuring Compliance Contents Executive summary ............................................................ 17 Off-label strategies .................................... 27 MSL training ................................................... 8 US rules on off-label promotion ............................................................................................................................................................................................................................................................................................ 23 What SOPs should address .... 19 Increased scope of CIAs ..............................................................................................................................................

............................ 42 Enforcement policy in the US.......................... 44 Acknowledgements ................................................ 35 Case study 1: mid-size pharmaceutical company................................................................................................................................................................... All Rights Reserved .............................................................. 32 Compensation and metrics......................... 42 Enforcement policy in the UK ............ 43 Individual responsibility .... 36 Case study 2: medical device company.................................... 34 Qualitative metrics...................................................................................................................................................................................................MSL-KOL Engagement: Ensuring Compliance Technological advances ............................................................................................................................................... 40 Enforcement policies ................. 47 ii June 2011 All Contents Copyright © 2011 Doctor's Guide Publishing Limited................ 34 Quantitative metrics ......................................................................................................................................................... 38 Board considerations.....................

and how companies are responding to enforcement measures. thus risking the integrity of the entire profession before it has had time to fulfill its potential in modern pharmaceutical practice? These questions.4 billion Eli Lilly had been forced to pay earlier that year for marketing Zyprexa to patients who do not have the drug’s two approved indications. cases are increasingly being tried and settled at levels that can no longer be regarded as just a cost of business. In September 2009. where a de facto policy of limited rulemaking and broad enforcement by threat of criminal prosecution is forcing companies to examine their compliance policies. particularly in the US. more importantly. Physicians want to talk about these uses and companies have an interest in sharing the latest scientific information. are answered in a rare look at the practice of off-label promotion. Pfizer paid $2.3 billion to settle charges that it improperly promoted four products. This trumped the $1. how do they ensure those actions are seen to be appropriate? How do they prevent MSLs from acting as sales reps in another guise. June 2011 All Contents Copyright © 2011 Doctor's Guide Publishing Limited. All Rights Reserved 1 . and others. which can leave MSLs with the difficult question of how to apply the broad policy that forbids off-label promotion in virtually every market in the world. for schizophrenia and bipolar disorder. The true extent of off-label promotion is not known but in the US. where whistleblowers are both protected and incentivised to provide evidence against their employers. there is also the risk that individual executives will be held to account. How do companies ensure MSLs always act appropriately to requests for information about off-label uses and. If fines and the threat of a corporate integrity agreement (CIA) are not sufficient impetus to get compliance procedures in order. But while rising numbers of them are being hired to educate researchers and prescribers about a company’s products they often find themselves treading a thin and contentious line when those products are known to be used off-label.MSL-KOL Engagement: Ensuring Compliance Executive summary Medical science liaisons (MSLs) are the healthcare consulting professionals at the vanguard of a new way of engaging with physicians. its regulation on both sides of the Atlantic.

“While there are strict codes of conduct they don’t really have specific guidance for MSLs or the MSL-type role. there is still lack of clarity on the appropriate non-promotional activities of MSLs. While the rules surrounding off-label promotion are clear (see below). and nowhere is that line more apparent than when a product is known to have off-label uses that HCPs want to talk about and companies have an interest in encouraging. how policy might be changing individuals’ roles within the delivery of healthcare. whether it be in radiology or cardiology.MSL-KOL Engagement: Ensuring Compliance of care is changing and evolving. “While there are strict codes of conduct they don’t really have specific guidance for MSLs or the MSL-type role.” he says.” 6 All Contents Copyright © 2011 Doctor's Guide Publishing Limited. All Rights Reserved June 2011 . or in monitoring. This is really responding to the value we’ve seen from these interactions in terms of providing us with new insights into healthcare and how we can respond with solutions to improve the delivery of care and patient outcomes. “Because it is a relatively new role within the pharmaceutical industry. the question of how companies should apply the broad commandment that forbids it to the daily routine of interacting with HCPs can often be a difficult one for MSLs and their managers. Companies have to individually create their own guidelines on MSL activities.” Education versus promotion There is a thin line between educating healthcare professionals (HCPs) about a product and promoting it. there is still lack of clarity on the appropriate non-promotional activities of MSLs.” Macgregor spells out the ambiguity in Europe. and so on. Companies have to individually create their own guidelines on MSL activities. “Because it is a relatively new role within the pharmaceutical industry.” he says.

The move was apparently prompted when companies stopped issuing drug samples to cataract surgeons due to concerns about charges of off-label promotion. payer-related practices such as discussions with prescribers about ways to ensure insurance reimbursement for off-label prescriptions. internal practices such as sales quotas that could only be met if the sales force promoted off-label drug use.org/article/info%3Adoi%2F10. antidepressants approved for adults being promoted to paediatricians.plosmedicine. “I hope the FDA itself does not block the ability of the companies willing to do new studies and get FDA approval.osnsupersite. for example. which “can be used to develop new regulatory strategies aimed at effective oversight of off-label marketing. The idea. says. say the authors. indicate three main non-mutually exclusive goals of promoting drugs off-label.com/view. Dr Daniel S. shown in Figure 5.” 17 The results. and consumer- 16 17 http://www.MSL-KOL Engagement: Ensuring Compliance The clinician’s perspective The practice is so widespread in some areas that doctors are calling for cost-effective trials to be conducted on common off-label uses of drugs. All Rights Reserved 17 . A third was to promote unapproved. refractive surgery section editor of Ocular Surgery News (OSN). The most obvious. The Alliance of Speciality Medicine. typically higher. The authors also identified four non-mutually exclusive types of marketing to achieve these goals: prescriber-related practices such as financial incentives and free samples. the Public Library of Science (PloS) Medicine published a retrospective analysis of 41 complaints into off-label promotion arising from 55 whistleblowers from January 1996 to October 2010.aspx?rid=81827 http://www. was to get a broader picture of the practice.pmed. was to expand a drug’s use into unapproved indications. Another was to expand use into unapproved disease subtypes. in 85 percent of cases. dosing strategies.” 16 Off-label strategies In April 2011. which includes the American Society of Cataract and Refractive Surgery.1371%2Fjournal. wants the FDA to help drug companies design such trials. We should be able to develop a system that is good for the clinicians and provides specific data on surgical outcomes. Durrie.1000431 June 2011 All Contents Copyright © 2011 Doctor's Guide Publishing Limited.

” says Dale Kummerle. so why not have them for MSL activity?” asks Dr Zlata Caric. so why not have them for MSL activity?” asks Dr Zlata Caric. All Rights Reserved June 2011 . we are starting to see more SOPs to stratify the procedures a company endorses with respect to MSL conduct.MSL-KOL Engagement: Ensuring Compliance Standard operating procedures Interactions between MSLs and HCPs have always been a legal minefield because the potential for promoting an unapproved product is always present. “The compliance guidance provided by the government can be interpreted in different ways by different companies. has significantly enhanced the need for board members. coupled with higher penalties. “It gives clear guidance to MSLs and to the organisation as to how the government guidance is defined. “I know a few companies working on developing SOPs but this is a new development and I expect others to follow. It doesn’t help that while there are regulations in all countries banning off-label promotion. managing director of Lener Medical Consulting. there are no specific regulations for MSLs. But the increased scope of recent CIAs. medical information. “I know a few companies working on developing SOPs but this is a new development and I expect others to follow.” “We have SOPs for clinical research. as well as ever-stricter industry codes of practice. director of medical education of MSLs at Bristol-Myers Squibb.” Accordingly. This gives a certain peace of mind that you are working within a framework that has been approved and that you’re not doing anything risky. “We have SOPs for clinical research.” 22 All Contents Copyright © 2011 Doctor's Guide Publishing Limited. medical information. via compliance officers. managing director of Lener Medical Consulting. This is why having SOPs is really helpful. to know that MSL teams are conducting themselves appropriately at all times.

Simple as that. Other activities include developing product labels. we are talking about scientific exchange. and those should be the metrics. Quantitative metrics The metrics should be concrete and reachable goals that apply to each MSL’s activities. 24 Some of the common metrics used to measure MSL performance are: x x x x x x Number of investigator-initiated trials (IITs) submitted Number of KOLs visited Age and depth of relationship with KOLs Number of articles/publications authored Number of scientific/educational speeches delivered Customer feedback “The main metrics MSLs are measured on are the number of IITs submitted.MSL-KOL Engagement: Ensuring Compliance Compensation and metrics With increased emphasis on building and maintaining long-term relationships with KOLs. “Companies need to make sure MSLs are also evaluated on the basis of compliance. “Well.com/newsevents/press-releases/successful-medical-science-liaison-compensation/ 34 All Contents Copyright © 2011 Doctor's Guide Publishing Limited. we all know what the sales metrics are.” says the “keeper of SOPs” who asked to remain anonymous. then it’s almost always a yearly evaluation. “Another is identifying and building new KOL relationships. and the MSLs metrics are none of them. All Rights Reserved June 2011 . quarterly or yearly basis. we are talking about publications. If the company has a pre-existing certification or compliance-training programme in place. the MSL role must be based on fair metrics to evaluate performances and reward appropriately. These activities can be monitored on a monthly. then we are talking about clinical trials. But I’ve worked for a number of companies that 24 Cutting Edge Information-How to Compensate a Winning MSL Team-http://www.cuttingedgeinfo. and the number of KOL visits. building scientific collateral information and training sales reps. If you are talking about the MSLs’ role as being scientific.” says Dr Dyer.

in March 2011.” says John Osborn.pdf June 2011 All Contents Copyright © 2011 Doctor's Guide Publishing Limited. All Rights Reserved 43 . There is also legal friction when trying to square the ban with the First Amendment right to free speech. the risk alone was enough to alter a company’s defenses. 26 Enforcement policy in the US “The risk/reward calculus is skewed dramatically in favour of settlement when a loss would jeopardise the firm’s viability by forfeiting government reimbursement for its products. legal arguments based on free speech have carried less weight since a 1998 revision to a rule issued by the OIG that expanded its authority to exclude drug manufacturers from receiving federal health reimbursement if they are found to have engaged in significant financial or other impropriety. which has only been authorised for colorectal. lung and breast cancer. off-label use was described as an undefined area in which coordination is lacking at European level. former executive vicepresident and general counsel of Cephalon. In its background report on innovation for a ministerial conference in September 2010. where there are higher penalties for non-compliance and more exposure of wrongdoing via the False Claims Act.com/Off-label_-_Final_version_article_-_Extended_edition. This effectively leaves UK opthamologists with little alternative than to use cancer drug Avastin. However.MSL-KOL Engagement: Ensuring Compliance wet age-related macular degeneration. Off-label promotion is more hotly debated in the US.lifesciences. This alleged violation of European rules has not been tested in the courts but it is reflected in calls from the 2010 Belgian EU Council Presidency for greater clarity on off-label use across the union. Even though the OIG has said it did not expect this expanded rule to result in manufacturers being convicted and subject to mandatory exclusion. which creates financial incentives for whistleblowers.nautadutilh. “The risk/reward calculus is skewed dramatically in favour of settlement when a loss would jeopardise the firm’s viability by forfeiting 26 http://www.

com) as the co-author of this study. director. global director of MSLs. chief medical officer. All Rights Reserved 47 . UCB Dr Robin Winter-Sperry. director of consulting. medical education. Philips Healthcare Dale Kummerle. FirstWord would also like to thank the following participants for their time and insights: Drew Macgregor. Scientific Advantage Kevin Appareti. Philips Healthcare Yanis Saradjian.MSL-KOL Engagement: Ensuring Compliance Acknowledgements FirstWord would like to acknowledge Dr Samuel Dyer. president and CEO. president. CEO of Medical Science Liaison World (www. vice-president of global medical affairs. medical operations manager. Bristol-Myers Squibb Dr Zlata Caric. Bristol-Myers Squibb Europe Lode Dewulf. Cutting Edge Information June 2011 All Contents Copyright © 2011 Doctor's Guide Publishing Limited. Lener Medical Consulting Dr Eric Silfen.mslworld.