Rules of Engagement for MSLs - Appropriate Interactions with Internal and External Stakeholders Daniel Snyder, PhD Medical Director, Neurology North America Medical Affairs Ipsen Biopharmaceuticals, Inc. 1
Disclaimer I am an employee of Ipsen Biopharmaceuticals, Inc. (Ipsen). The statements or opinions expressed in this presentation are my own and do not necessarily represent those of Ipsen. 2
Agenda How did we get to Rules of Engagement? 1. Responding to Unsolicited Request for Off-Label Information 2. Distributing Scientific and Medical Publications on Unapproved New Uses 3. OIG Compliance Policy Guidance (CPG) for Pharmaceutical Manufacturers Where does guidance come form? When to use a MSL Responding to an unsolicited request Rules of Engagement with Commercial Sales Reimbursement Managed Markets 3
Legal Guidance No legal or regulatory requirement to maintain independent Medical Affairs department; only guidance documents 1. Responding to Unsolicited Requests for Off-Label Information Draft Guidance December 2011 2. Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices Draft Guidance February 2014 3. OIG Compliance Policy Guidance (CPG) for Pharmaceutical Manufacturers May 2003 4
Responding to Unsolicited Requests for Off-Label Information FDA Draft Guidance document December 2011 Definition of Unsolicited Request: Initiated by persons or entities that are completely independent of the relevant firm Can be non-public or public Non-public directed privately to the firm Public made in a public forum, either to the firm or to a forum at large Requests that are prompted in any way by the manufacturer are not unsolicited 5
Responding to Unsolicited Requests for Off-Label Information (cont.) Responses must meet the following requirements: Truthful, balanced, non-misleading, accurate; Tailored to respond to the specific question asked; Information should only be provided to the individual making the request; and If question is too broad, it should be narrowed Additional Requirements to be Included in Response: FDA-approved labeling, including important safety information; A prominent statement notifying the recipient that FDA has not approved the product as safe and effective for use in the materials provided; and A complete list of references for all information disseminated in the response Adequate records should be maintained regarding nature of request, information provided and follow-up inquiries, if any 6
Distributing Scientific and Medical Publications on Unapproved New Uses FDA Draft Guidance February 2014 Recommendations for manufacturers who choose to distribute scientific or medical journal articles that include unapproved/uncleared uses of its product(s) Must be published by an organization with an editorial board that uses experts who have expertise in the subject matter of the article If recommendations are followed, FDA does not intend to use distribution as evidence of intent that product(s) be used for unapproved new use 7
Distributing Scientific and Medical Publications on Unapproved New Uses Recommendations for Scientific Journal Articles Be peer reviewed and published in accordance with peer-review procedures of organization Be in the form of an unabridged reprint or copy Contain information that describes adequate and well-controlled clinical investigations Be disseminated with approved labeling for each of product included in article Be disseminated with a comprehensive bibliography (when it exists) of publications discussion adequate and well-controlled studies published in scientific or medical journals Be disseminated with a representative publication (when it exists) that reaches contrary or different conclusions regarding the unapproved use Be distributed separately from the delivery of information that is promotional in nature 8
Distributing Scientific and Medical Publications on Unapproved New Uses Other Recommendations for Scientific Articles Must not : Be false or misleading Contain information recommending or suggesting the use or product that makes it dangerous to health when used in such matter Should not : Be in a form of special supplement or publication funded by manufacturer Be marked, highlighted, summarized or characterized to emphasize or promote unapproved use Be primarily distributed by manufacturer (i.e., should be generally available publicly Be written, edited, excerpted, or published specifically for or at the request of manufacturer Be edited by manufacturer (or another 3 rd party paid by manufacturer) Be attached to specific product information, other than approved label 9
Distributing Scientific and Medical Publications on Unapproved New Uses Accompanying Statement Include prominently displayed and permanently affixed statement disclosing: Drug included in journal reprint which manufacturer has interest; Some or all uses of manufacturer s drug(s) described in information have not been approved or cleared by FDA; Any author known to manufacturer having a financial interest in a product included in article or is receiving compensation from manufacturer (including nature and amount), along with affiliation of author; Any person known to manufacturer who provided funding for study; and All significant risks or safety concerns associated with unapproved use(s) of product discussed in article known to manufacture, but not discussed in it 10
OIG Compliance Policy Guidance (CPG) for Pharmaceutical Manufacturers May 2003 Separation of sales and commercial from medical and scientific functions to reduce the risk of fraud and abuse: Educational grants; research funding Consulting Arrangements Consulting and Advisory Payments to HCPs Should comply with the PhRMA Code Failure to implement policies to minimize risk of sham arrangements increases risk of violating Federal Anti-Kickback Statute (AKS) 11
Where does guidance come from? Separation of Medical Affairs function is understood by government enforcement activities Three (3) Main Areas of Focus: 1. Commercial interactions with Medical Affairs 2. Advisory Boards 3. Continuing Medical Education and Educational Grants 12
Recent Enforcement Commercial and Medical Interactions Allegations include: Off-label promotion by Medical Affairs personnel in violation of Federal Food, Drug and Cosmetic Act (FDCA); Off-label promotion by Medical Affairs personnel used as evidence to support FCA allegations Unlawful remuneration paid by medical affairs to third parties in violation of the AKS (and thus, FCA, in some cases) 13
Recent Enforcement Commercial and Medical Interactions (cont.) Types of Allegations Include: MSLs rode with sales reps to answer questions on research/clinical studies to initiate off-label discussions MSLs reported indirectly to sales directors MSLs used to market product for off-label uses MSLs develop Thought Leaders who would support and promote off-label uses; support off-label publications Other Risk Areas Publications and investigator-initiated studies (IIS) Commercial involvement in funding IIS or patient recruitment Engagement of contractors to write journal articles about off-label uses 14
Recent Enforcement Advisory Boards Purpose of market research is to collect information from a targeted audience; should be fair discussion of information provided Disguising promotional programs as marketing research or scientific exchange is prohibited Allegations include: Programs funded through promotional budget and organized by commercial staff Sales reps select the HCPs based on how much they prescribe the product Meetings are passive with no actual feedback (thus, disguised kickbacks to physicians) 15
Recent Enforcement CME and Educational Grants Can provide funding for Medical Education programs as long as it is bona fide and arm s length and manufacturer does not control the content or faculty Allegations include: Funding programs for purpose of off-label promotion or providing improper remuneration to HCPs Improper influence of content of company-sponsored CME Improper control of speakers by manufacturer 16
When to Involve a MSL Request a MSL when... Physician Interest in Research Knowledgeable, experienced, have subjects ISS, R&D, other support Review scientific research Unsolicited requests for off-label information Requested disease state presentation Review complicated scientific material in depth Physician Education Needs Requests for specific information related to company drug Request follow-up regarding an institutional educational event (educational grant request) 17
How Does A Med Affairs Team Respond to Unsolicited Requests from the Customer? How do we do this? Commercial captures the question from the customer, completes the medical information request form, captures the customer signature, and submits through appropriate channel. Medical Information or and/or MSL addresses customer question. Medical Information and/or MSL informs Commercial that the case has been completed. Commercial cannot dial the hotline number or MSL on a phone and hand the phone over to the HCP. 18
Medical Information vs. MSL Request When to request Medical Information General requests related to company-sponsored pivotal trials outside of scope of approved promotional materials Efficacy/Safety/Dosing information/product manufacturing issues General requests related to company-sponsored non-pivotal trials outside of scope of approved promotional materials Published or data on file Publication/standard response letter requests to specific scientific/clinical question Please send studies/information that discuss the data on maximum dose of drug. If Medical Information believes the question needs more clarification or it is a complex answer, Medical Information may send request to the MSL or another pertinent department 19
Medical Information vs. MSL Request Continued When to request a MSL Specific requests related to a given situation, patient type or training question outside the scope of approved promotional materials (that may require a more complex answer and/or discussion) How much drug should be administered? HCP requests information from a non-company sponsored publication, medical conference, or other sources of scientifically valid/significant data outside of a journal publication that relates to one of the company s drugs Requests to discuss a research study idea (i.e., ISS) or to ask to participate in an company-sponsored clinical trial. HCP specifically requests a MSL Sales is not comfortable answering an in-depth scientific question. 20
Interactions between the MSL and Commercial MSL and Commercial Interactions General Principles Sales Personnel, Reimbursement Managers, the Managed Markets personnel and MSLs all have specialized non-overlapping roles but may interact with the same account or HCP that is affiliated with a specific account. It may be appropriate for members from different teams to be aware if they are meeting with a HCP or HCO that is called on by multiple field-based personnel, and share the communication style and logistic characteristics of common contacts. The fact that a visit occurred and the timing of the visit may be shared. Maintain firewall (e.g., Sales representative does not share prescription volume of an account with the MSL, and conversely, the MSL does not share subject matter or content of his/her discussion with the KOL/HCP with Sales) On an as-needed basis, MSLs may meet with Commercial field-based personnel for the purpose of clarifying on-label and disease state information the personnel were already trained on. Off-label discussions between the MSL and Commercial field-based personnel are strictly prohibited. 21
Interactions between the MSL and Commercial Continued Responding to Unsolicited HCP Requests for Medical Information The MSL must confirm the unsolicited request in the medical information request form with the HCP within 48 hours of receipt. The purpose of this confirmatory telephone conversation or e-mail is to ensure the MSL understands the question or request. Commercial personnel who submit a medical information request form are permitted to provide the MSL a notification that they will receive a medical information request form via e-mail (preferred) or by phone call. Only details about the HCP and their location may be provided in this communication (i.e., no details about the unsolicited question may be provided). 22
Interactions between the MSL and Commercial Continued Guidance on Joint Calls Sales Sales personnel and MSLs may not make joint calls with HCPs. May facilitate meet and greet opportunities in those instances where the HCP is known to one party and not the other. MSL must leave before a sales presentation or discussion; sales personnel must leave before a scientific discussion between an MSL and HCP. MSL cannot engage in a telephone conversation with an HCP while sales personnel are present. If asked by the MSL, they may indicate whether HCP is a company advocate, is neutral, or is a detractor. Reimbursement Managers (RMs) Reimbursement Managers (RMs) and MSLs may not make joint calls to individual HCPs offices. Occasionally, MSLs and RMs may attend a meeting with HCPs when it is likely both scientific and business issues will be discussed (i.e., hospital formulary discussion, advisory board or trade conference). 23
Interactions between the MSL and Commercial Continued Guidance on Joint Calls Continued Managed Markets Managed Markets personnel interactions with Payers (Commercial and Government), GPO, SPPs, Retailers, and Distributors may be conducted with a MSL when it is likely that discussion of both scientific and business issues will take place. MSLs may also participate in meetings with Integrated Delivery Networks (IDNs) when requested in advance by the IDN. In the event an off-label question is asked by a HCP in this setting, the MSL may respond to the unsolicited request for off-label information as directed by company policy. The Managed Markets member may remain in the room but may not engage in the off-label discussion. 24
Interactions between the MSL and Commercial Continued Out-Of-Office HCP Meals MSLs may attend meals provided by the Managed Markets team provided they have a legitimate reason to be part of the business discussion (i.e., a meeting that includes a clinical presentation). Sales personnel may not attend these meals. 25
Thank you! 26
Federal Anti-Kickback Statute (AKS) Prohibits a person from knowingly and willfully offering, paying, soliciting or receiving any remuneration directly or indirectly, overtly or covertly, in cash or kind to induce or reward referrals of items or services reimbursable by a Federal health care program. 42 U.S.C. 1320a- 7b(b) Remuneration is anything of value, cash or in-kind. See e.g., OIG Advisory Opinion No. 98-2, at 5 (Apr. 8, 1998) One purpose test statute is implicated if one purpose of the remuneration is to induce Federal health care program business, even if such inducement is not sole or primary purpose. See, e.g., United States v. Kats, 871 F2d. 105 (9 th Cir. 1989); United States v. Greber, 760 F.2d 68 (3d Cir. 1985), cert. denied, 474 U.S. 988 (1985) To be considered inducement, the remuneration need only be intended to influence the judgment of the recipient (no direct quid pro quo required) 27
False Claims Act (FCA) 31 USC 3729, et seq. Civil statute that imposes liability for knowingly: Presenting or causing to be presented a false or fraudulent claim; Making, using or causing to be made or used a false record or statement material to a false or fraudulent claim Claims resulting from a kick-back violation are false or fraudulent acts under FCA Penalties include: $5,500 to $11,000 per claim 3x damages 28