Fraud & Abuse Guarding Against Off Label Promotion Jonathan Levy PDMA Executive Board
AGENDA Promotion Labeling Training Sales Representatives For Execution of On Label Messaging Speaker Standards Monitoring Separation of Commercial from Medical Market Access Representatives Amarin Court Decision: What the Future of Promotion Might Look Like 2
TOOLS TO ENSURE PROMOTION IS ON LABEL Training to Promote Product Consistent with Label On vs. Off Label: Ensure Field Facing Teams know Label Policies Against Off Label Promotion Monitoring Promotional Activities Promotion vs. Scientific Exchange - Knowing the Difference 3
Tactics to Ensure Promotion is Executed On Label Develop/Execute On Label Content for Proactive Discussion with Customer Speaker Standards Monitoring Field Coaching Risk Based Approach Data Analytical Results (Holistic; Actionable) Commercial Separate from Medical 4
What is Promotion? What is Labeling? Promotion (as distinct from Scientific Exchange) Non Promotional Information Label Definition Scope of Materials Manner of Execution Written Verbal 5
What is Promotion? What is Scientific Exchange? Promotion: Whatever a Manufacturer Says Proactively About its Product in order to Shape Perceptions of the Product FDA is more concerned about the content of a company s presentation of information other than the title of person providing content FDA regulates Activity (Promotion) Not Roles Whatever Employee/Agent Proactively Says is Promotional, Whether the Representative Fills a Commercial or Medical Role FDA Rules: Company (or someone acting on behalf of company) can NOT Promote off label uses Suggest an investigational product is safe and effective, or Provide False or Misleading Information 6
Scientific Exchange Exceptions to Rules Around Regulated Promotional Content Exception #1: Communications to Clinical Investigators Manufacturer is obligated to keep investigators in ongoing trials informed about emerging data on the product if data is relevant to trial Communication typically developed by R&D 7
Scientific Exchange #2: Publication at Independent Symposia; Press Release Manufacturer may release new and scientifically noteworthy data through Scientific publication or presentation at independent major symposia to support the advance of science Press Releases to keep investors adequately informed of material developments to Manufacturer Co 8
Exception #3: Responding to Unsolicited Questions Manufacturer can respond to unsolicited questions from Healthcare Care Professionals (HCPs) about Data on investigational compounds or data outside of approved label Response must be balanced, non-promotional and scientifically accurate 9
Exception #4: Educational Symposia Financial Support for fully independent Continuing Medical Education (CME) Manufacturer NOT to influence CONTENT or Structure of program conducted by independent Third party 10
Non Promotional - Summary of Topic Exceptions Data Provided to Investigators Relevant to Ongoing Trials Scientific Publications Responses to Unsolicited Requests for Information Disease Awareness Communications (Unbranded) Continuing Medical Education (CME)-type activities 11
Label and Labeling Definition: Federal Food, Drug, and Cosmetic Act (FDCA) Label: a display of written, printed, or graphic matter upon the immediate container of any article... Labeling: All labels or other written, printed, or graphic matter (1) upon any article or its containers or wrappers, or (2) accompanying such article" 12
Labeling Posters, Tags, Pamphlets, Circulars, Booklets, Brochures, Instruction Books, Direction Sheets, WEBSITES, other promotional materials Term Labeling is Broad to Extend beyond Physical Association with Product Must Function as Labeling Explain Product to Help in Product s Use Supplied or Disseminated on Behalf of Manufacturer, Packer, Distributor Prepared by Persons having Commercial Interest in Product 13
LABELING Verbal Statements can change a product s intended use and When Proactive Must be Consistent with/directly IN Label. Otherwise, statements can get Company in trouble E.g. This product can be used for [fill in off-label] or Our product is better than Product X [which is approved for a particular use, but we are not] 14
Advertising Must be On Label FDCA not define Advertising Can include Ads in Published Journals, Magazines, Periodicals, Newspapers Ads Broadcast through Media: Radio, Television, Telephone, Internet/Website 15
Continued Topics Field Facing Representatives TRAINED on ROLE: Sales, Speakers, Medical, Access Sales Call Speaker Standards Medical distinct from Commercial Internal Field Facing Access Interactions MONITORING Field Coaching Risk Based Strategy/Implementation Data Analytics Amarin Court Decision 16
SALES FORCE: KNOWING Rules of Promotion Presentations must be balanced and complete Presentations must be truthful and not misleading No initiating or prompting off label discussions Use only approved materials No pre-approval promotion Key Activities of Promotion Sales Calls Speaker Programs 17
Sales Call Fairly balance efficacy statements with safety/tolerability Review only product information that is consistent with approved labeling Refer unsolicited off label questions to Medical Review Important Safety Information Separate Branded Discussion from Unbranded Disease State to Prevent Implicit Broadening of Product s Label 18
Promotional Agents of Company: Speaker Standards As Manufacturers Agents, Subject to Rules of On Label Proactive Promotion Speaker should identify that speaking on behalf of Manufacturer Use Materials provided by Manufacturer Not suggest a product is safer or more efficacious than data in approved product labeling demonstrates Not initiate discussion regarding unapproved uses, doses not consistent with product promoting Not respond to off label questions before entire audience After proactive presentation, May Answer Off label question by providing response to individual asking question Off label response must be scientifically accurate, balanced 19
Role of Medical Role of Medical To Interact with Thought Leaders for Scientific Discussion about Product, a therapeutic area, or unmet medical need in a given therapeutic area Provide clinical trial support Communicate insight and feedback from healthcare professionals, including medical insights Support Access to Manufacturer s medicines by providing medical presentation to Pharmacy & Therapeutic (P&T) Committees Scientific Exchange How Can Internally Interact with Sales How Can Respond to Questions Asked to Sales by Customers Provide Responses to Unsolicited Off Label Questions 20
Medical Distinct from Commercial Medical Should not conduct Sales Call with Sales Representatives Goals of Medical are Distinct from Sales Sales: Focus on promoting awareness of a company s products Medical: Focus on Advancing the Science, Data, and Answering medical questions Medical is Not to proactively discuss off label information about manufacturer s product Can work with Sales to identify geographic region need for educating HCPs about product on-label use, disease state or related medical information Sales and Medical can share high level strategies, but tactical execution with HCP, and reasons for/goals to accomplish with HCP should be clear and separate 21
Access- Promotional in Rx Context or Something Else? Not exactly Sales; Not Medical Customer is Payer Managing Patient Populations/Coverage Decisions; Customer Not Making Individual Prescription Decisions Might Be Appropriate for Access Representatives to Co-Travel with Medical to Appear before Customer 22
Monitoring What s it all about: Verifying that Standards and Practices are Workable and Followed METHODS Risk-Based Review of Activities/Products- Pre-Planning and/or Reactive Data Analytics- Data and Trend Analyses Course Corrective Action/Field Coaching 23
Monitoring: Risk-Based Review (Planned and Post Field Execution) New Products/Indications Significant Changes in Business Strategy Based on Results from Investigations, Prior Monitoring, Internal Audits Corporate Risk Assessment Results METHODS Transactional (Call Notes, Verbatims, Email reviews, Meals with HCPs, T&E) Live (Sales Ride Alongs; Speaker Programs, Congresses, Advisory Boards) 24
Monitoring: Data Analytics (Largely After Activity Review) Actionable data to aid business planning and decision making Provide Holistic review of business - not based on samples or direct observations Purpose is to Identify, Correct, and Prevent Mistakes Offer Metrics to Show Government/Audit Inquiry How Given Issue Was Addressed 25
Monitoring: Field Coaching Ride Alongs- Managers or Compliance Correction Action Forms Field Coaching Summaries Coach versus Escalate Seriousness Flagrancy of violation Repeated nature 26
Amarin: What Decision Means for Future of Promotion 1 st Amendment challenge to Food Drug and Cosmetic Act s (FDCA) Requirement that Manufacturer Promotion Limited to On Label Facts: Amarin manufacturer Vascepa, a triglyceride-lowering drug approved in 2012 for treatment of adult patients with very high triglycerides- approved based on MARINE study While completing MARINE study, Amarin entered into a Special Protocol Assessment (SPA) with FDA to conduct second study, called ANCHOR, designed to study efficacy of Vascepa for patients with persistently high tryglyceride levels SPA designed to provide manufacturer with regulatory predictability. If Manufacturer follows procedures set forth in SPA process, FDA may rescind SPA only if there is identified and unresolved substantial scientific issue essential to determining safety of effectiveness 27
Amarin Continued ANCHOR ultimately not approved Subsequent to ANCHOR, Amarin and FDA enter into another SPA for REDUCE-IT Study designed to evaluate whether Vascepa effective in helping prevent major cardiovascular events in high risk patients Amarin sought injunction preventing FDA from bringing misbranding action against it if promote Amarin under ANCHOR and REDUCE IT studies Argued FDA could not prohibit Amarin under First Amendment commercial speech protections from proactively disseminating truthful and non misleading speech outside of its product s approved label 28
Amarin Decision- August 2015 WHAT COURT RULED FDA Cannot prohibit manufacturer from Proactively Disseminating Truthful Information about Product, even though Not Consistent with Approved Labeling If Off Label, Must Still be Truthful, Non-Misleading Information Disseminated Proactively Suggest Scripted Responses so that Responses Not become Misleading, If Inconsistent with Label, Should Still be Balanced Not Preclude FDCA liability based on violations of Anti-Kickback Statute (AKS) 29
PACIRA Litigation Manufacturer Pacira Pharma, after Amarin decision, filed complaint on Sept 8, 2015 against FDA concerning EXPAREL, Pacira s local anesthetic product Pre approval clinical trials involved use of product for bunionectomies and hemorrhoidectomies Pacira argue FDA approval broader that use in these two surgeries Challenge FDA s issuance of a Warning Letter to Pacira for Co s promoting use of Exparel in broader scope of surgeries to produce postsurgical analgesia Similar First Amendment Challenge to Amarin, but challenging Warning Letter Premised on Promotion which Manufacturer believe Consistent with Approved Label, and Also Truthful even if not expressly within label 30
DOJ Yates Memo: Individual Accountability for Corporate Wrongdoing Accountability of Individuals for Corporate Wrongdoing In Healthcare Field, Promotion of False Off Label Info (i.e., not supported by FDA approved study or misleading characterization of data), Can Be Basis to Pursue Individuals under Food Drug Cosmetic Act Park Doctrine- Responsible Corporate Officer 31
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