Your SlideShare is downloading. ×
Medical Science Liaison (MSL) and KOL Regulatory Compliance
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

×
Saving this for later? Get the SlideShare app to save on your phone or tablet. Read anywhere, anytime – even offline.
Text the download link to your phone
Standard text messaging rates apply

Medical Science Liaison (MSL) and KOL Regulatory Compliance

8,795
views

Published on

Understand how the new regulatory laws and guidelines going into affect in 2012 will have an impact on pharmaceutical companies and the relationship between Medical Science Liaisons and KOLs.

Understand how the new regulatory laws and guidelines going into affect in 2012 will have an impact on pharmaceutical companies and the relationship between Medical Science Liaisons and KOLs.


0 Comments
1 Like
Statistics
Notes
  • Be the first to comment

No Downloads
Views
Total Views
8,795
On Slideshare
0
From Embeds
0
Number of Embeds
4
Actions
Shares
0
Downloads
389
Comments
0
Likes
1
Embeds 0
No embeds

Report content
Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
No notes for slide

Transcript

  • 1. June 2011MSL-KOL Engagement:Ensuring ComplianceA FirstWord ExpertViews Report
  • 2. MSL-KOL Engagement: Ensuring ComplianceReport Title: MSL-KOL Engagement: Ensuring CompliancePublished June 2011© Copyright 2011 Doctor’s Guide Publishing LimitedAll rights reserved. No part of this publication may be reproduced or used in any form orby any means graphic, electronic or mechanical, including photocopying, recording,taping or storage in information retrieval systems without the express permission of thepublisher.This report contains information from numerous sources that Doctor’s Guide PublishingLimited believes to be reliable but for which accuracy cannot be guaranteed. Doctor’sGuide Publishing Limited does not accept responsibility for any loss incurred by anyperson 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 arenot necessarily the views and opinions of Doctor’s Guide Publishing Limited. Any viewsand opinions expressed by individuals and reproduced in this document are notnecessarily the views and opinions of their employers.
  • 3. MSL-KOL Engagement: Ensuring ComplianceContentsExecutive summary .............................................................................................. 1Evolution of the MSL role....................................................................................... 2 What do MSLs do? .......................................................................................... 4 Education versus promotion ............................................................................. 6US regulations governing MSLs .............................................................................. 8 US rules on off-label promotion ........................................................................ 8 EU rules on off-label promotion ........................................................................ 9Off-label marketing cases .................................................................................... 11 A growing concern........................................................................................ 13 Off-label prescribing ..................................................................................... 15 The clinician’s perspective .......................................................................... 17 Off-label strategies ....................................................................................... 17Corporate integrity agreements ............................................................................ 19 Increased scope of CIAs ................................................................................ 19Standard operating procedures............................................................................. 22 Firewalling................................................................................................ 23 Clarification .............................................................................................. 23 What SOPs should address ......................................................................... 26 Globalisation............................................................................................. 27MSL training ...................................................................................................... 28 Frequency of training ................................................................................. 30Tracking and reporting systems............................................................................ 31June 2011 i All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved
  • 4. MSL-KOL Engagement: Ensuring Compliance Technological advances .............................................................................. 32Compensation and metrics................................................................................... 34 Quantitative metrics .................................................................................. 34 Qualitative metrics..................................................................................... 35Case study 1: mid-size pharmaceutical company..................................................... 36Case study 2: medical device company.................................................................. 38Board considerations........................................................................................... 40Enforcement policies ........................................................................................... 42 Enforcement policy in the UK ......................................................................... 42 Enforcement policy in the US.......................................................................... 43 Individual responsibility .............................................................................. 44Acknowledgements ............................................................................................. 47ii June 2011 All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved
  • 5. MSL-KOL Engagement: Ensuring ComplianceExecutive summaryMedical science liaisons (MSLs) are the healthcare consulting professionals at thevanguard of a new way of engaging with physicians. But while rising numbers of them arebeing hired to educate researchers and prescribers about a company’s products theyoften find themselves treading a thin and contentious line when those products are knownto be used off-label. Physicians want to talk about these uses and companies have aninterest in sharing the latest scientific information, which can leave MSLs with the difficultquestion of how to apply the broad policy that forbids off-label promotion in virtuallyevery market in the world.How do companies ensure MSLs always act appropriately to requests for informationabout off-label uses and, more importantly, how do they ensure those actions are seen tobe appropriate?How do they prevent MSLs from acting as sales reps in another guise, thus risking theintegrity of the entire profession before it has had time to fulfill its potential in modernpharmaceutical practice?These questions, and others, are answered in a rare look at the practice of off-labelpromotion, its regulation on both sides of the Atlantic, and how companies are respondingto enforcement measures, particularly in the US, where a de facto policy of limited rule-making and broad enforcement by threat of criminal prosecution is forcing companies toexamine their compliance policies.The true extent of off-label promotion is not known but in the US, where whistleblowersare both protected and incentivised to provide evidence against their employers, casesare increasingly being tried and settled at levels that can no longer be regarded as just acost of business. In September 2009, Pfizer paid $2.3 billion to settle charges that itimproperly promoted four products. This trumped the $1.4 billion Eli Lilly had been forcedto pay earlier that year for marketing Zyprexa to patients who do not have the drug’s twoapproved indications, for schizophrenia and bipolar disorder.If fines and the threat of a corporate integrity agreement (CIA) are not sufficient impetusto get compliance procedures in order, there is also the risk that individual executives willbe held to account.June 2011 1 All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved
  • 6. MSL-KOL Engagement: Ensuring Complianceof care is changing and evolving, how policy might be changing individuals’ roles withinthe delivery of healthcare, whether it be in radiology or cardiology, or in monitoring, andso on. This is really responding to the value we’ve seen from these interactions in termsof providing us with new insights into healthcare and how we can respond with solutionsto improve the delivery of care and patient outcomes.”Education versus promotionThere is a thin line between educating healthcare professionals (HCPs) about a productand promoting it, and nowhere is that line more apparent than when a product is knownto have off-label uses that HCPs want to talk about and companies have an interest inencouraging. While the rules surrounding off-label promotion are clear (see below), thequestion of how companies should apply the broad commandment that forbids it to thedaily routine of interacting with HCPs can often be a difficult one for MSLs and theirmanagers. “While there are strict codes of conduct they don’t really have specific guidance for MSLs or the MSL-type role,” he says. “Because it is a relatively new role within the pharmaceutical industry, there is still lack of clarity on the appropriate non-promotional activities of MSLs. Companies have to individually create their own guidelines on MSL activities.”Macgregor spells out the ambiguity in Europe. “While there are strict codes of conductthey don’t really have specific guidance for MSLs or the MSL-type role,” he says. “Becauseit is a relatively new role within the pharmaceutical industry, there is still lack of clarity onthe appropriate non-promotional activities of MSLs. Companies have to individually createtheir own guidelines on MSL activities.”6 June 2011 All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved
  • 7. MSL-KOL Engagement: Ensuring ComplianceThe clinician’s perspectiveThe practice is so widespread in some areas that doctors are calling for cost-effectivetrials to be conducted on common off-label uses of drugs. The Alliance of SpecialityMedicine, which includes the American Society of Cataract and Refractive Surgery, wantsthe FDA to help drug companies design such trials. The move was apparently promptedwhen companies stopped issuing drug samples to cataract surgeons due to concernsabout charges of off-label promotion. Dr Daniel S. Durrie, refractive surgery section editorof Ocular Surgery News (OSN), says, “I hope the FDA itself does not block the ability ofthe companies willing to do new studies and get FDA approval. We should be able todevelop a system that is good for the clinicians and provides specific data on surgicaloutcomes.” 16Off-label strategiesIn April 2011, the Public Library of Science (PloS) Medicine published a retrospectiveanalysis of 41 complaints into off-label promotion arising from 55 whistleblowers fromJanuary 1996 to October 2010. The idea, say the authors, was to get a broader picture ofthe practice, which “can be used to develop new regulatory strategies aimed at effectiveoversight of off-label marketing.” 17The results, shown in Figure 5, indicate three main non-mutually exclusive goals ofpromoting drugs off-label. The most obvious, in 85 percent of cases, was to expand adrug’s use into unapproved indications. Another was to expand use into unapproveddisease subtypes, for example, antidepressants approved for adults being promoted topaediatricians. A third was to promote unapproved, typically higher, dosing strategies.The authors also identified four non-mutually exclusive types of marketing to achievethese goals: prescriber-related practices such as financial incentives and free samples;internal practices such as sales quotas that could only be met if the sales force promotedoff-label drug use; payer-related practices such as discussions with prescribers aboutways to ensure insurance reimbursement for off-label prescriptions; and consumer-16 http://www.osnsupersite.com/view.aspx?rid=8182717 http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000431June 2011 17 All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved
  • 8. MSL-KOL Engagement: Ensuring ComplianceStandard operating proceduresInteractions between MSLs and HCPs have always been a legal minefield because thepotential for promoting an unapproved product is always present. But the increased scopeof recent CIAs, coupled with higher penalties, has significantly enhanced the need forboard members, via compliance officers, to know that MSL teams are conductingthemselves appropriately at all times.It doesn’t help that while there are regulations in all countries banning off-labelpromotion, as well as ever-stricter industry codes of practice, there are no specificregulations for MSLs. “The compliance guidance provided by the government can beinterpreted in different ways by different companies. This is why having SOPs is reallyhelpful,” says Dale Kummerle, director of medical education of MSLs at Bristol-MyersSquibb. “It gives clear guidance to MSLs and to the organisation as to how thegovernment guidance is defined. This gives a certain peace of mind that you are workingwithin a framework that has been approved and that you’re not doing anything risky.” “We have SOPs for clinical research, medical information, so why not have them for MSL activity?” asks Dr Zlata Caric, managing director of Lener Medical Consulting. “I know a few companies working on developing SOPs but this is a new development and I expect others to follow.”Accordingly, we are starting to see more SOPs to stratify the procedures a companyendorses with respect to MSL conduct. “We have SOPs for clinical research, medicalinformation, so why not have them for MSL activity?” asks Dr Zlata Caric, managingdirector of Lener Medical Consulting. “I know a few companies working on developingSOPs but this is a new development and I expect others to follow.”22 June 2011 All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved
  • 9. MSL-KOL Engagement: Ensuring ComplianceCompensation and metricsWith increased emphasis on building and maintaining long-term relationships with KOLs,the MSL role must be based on fair metrics to evaluate performances and rewardappropriately. “Well, we all know what the sales metrics are, and the MSLs metrics arenone of them. Simple as that. If you are talking about the MSLs’ role as being scientific,then we are talking about clinical trials, we are talking about publications, we are talkingabout scientific exchange, and those should be the metrics,” says the “keeper of SOPs”who asked to remain anonymous.Quantitative metricsThe metrics should be concrete and reachable goals that apply to each MSL’s activities. 24Some of the common metrics used to measure MSL performance are: x Number of investigator-initiated trials (IITs) submitted x Number of KOLs visited x Age and depth of relationship with KOLs x Number of articles/publications authored x Number of scientific/educational speeches delivered x Customer feedback“The main metrics MSLs are measured on are the number of IITs submitted, and thenumber of KOL visits,” says Dr Dyer. “Another is identifying and building new KOLrelationships. Other activities include developing product labels, building scientificcollateral information and training sales reps. These activities can be monitored on amonthly, quarterly or yearly basis.“Companies need to make sure MSLs are also evaluated on the basis of compliance. If thecompany has a pre-existing certification or compliance-training programme in place, thenit’s almost always a yearly evaluation. But I’ve worked for a number of companies that24 Cutting Edge Information-How to Compensate a Winning MSL Team-http://www.cuttingedgeinfo.com/news-events/press-releases/successful-medical-science-liaison-compensation/34 June 2011 All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved
  • 10. MSL-KOL Engagement: Ensuring Compliancewet age-related macular degeneration, in March 2011. This effectively leaves UKopthamologists with little alternative than to use cancer drug Avastin, which has onlybeen authorised for colorectal, lung and breast cancer. This alleged violation of Europeanrules has not been tested in the courts but it is reflected in calls from the 2010 Belgian EUCouncil Presidency for greater clarity on off-label use across the union. In its backgroundreport on innovation for a ministerial conference in September 2010, off-label use wasdescribed as an undefined area in which coordination is lacking at European level. 26Enforcement 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,” says John Osborn, former executive vice- president and general counsel of Cephalon.Off-label promotion is more hotly debated in the US, where there are higher penalties fornon-compliance and more exposure of wrongdoing via the False Claims Act, which createsfinancial incentives for whistleblowers. There is also legal friction when trying to squarethe ban with the First Amendment right to free speech. However, legal arguments basedon free speech have carried less weight since a 1998 revision to a rule issued by the OIGthat expanded its authority to exclude drug manufacturers from receiving federal healthreimbursement if they are found to have engaged in significant financial or otherimpropriety. Even though the OIG has said it did not expect this expanded rule to resultin manufacturers being convicted and subject to mandatory exclusion, the risk alone wasenough to alter a company’s defenses. “The risk/reward calculus is skewed dramaticallyin favour of settlement when a loss would jeopardise the firm’s viability by forfeiting26 http://www.lifesciences.nautadutilh.com/Off-label_-_Final_version_article_-_Extended_edition.pdfJune 2011 43 All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved
  • 11. MSL-KOL Engagement: Ensuring ComplianceAcknowledgementsFirstWord would like to acknowledge Dr Samuel Dyer, CEO of Medical Science LiaisonWorld (www.mslworld.com) as the co-author of this study. FirstWord would also like tothank the following participants for their time and insights:Drew Macgregor, medical operations manager, Bristol-Myers Squibb EuropeLode Dewulf, vice-president of global medical affairs, UCBDr Robin Winter-Sperry, president and CEO, Scientific AdvantageKevin Appareti, global director of MSLs, Philips HealthcareDale Kummerle, director, medical education, Bristol-Myers SquibbDr Zlata Caric, president, Lener Medical ConsultingDr Eric Silfen, chief medical officer, Philips HealthcareYanis Saradjian, director of consulting, Cutting Edge InformationJune 2011 47 All Contents Copyright © 2011 Doctors Guide Publishing Limited. All Rights Reserved

×