Pharmaceutical Compliance Forum Trends in Pharma Enforcement and Compliance September 15, 2009
Discussion Topics Key Enforcement Trend: Beyond Sales and Marketing Compliance Trends Oversight and Accountability Tracking & Monitoring (Embedding Compliance) Responding to Potential Misconduct Transparency & Disclosure Questions and Answers PCF: Trends in Pharma Enforcement & Compliance 2
Cautionary Notes Company-specific citations in slide and accompanying discussion based on public sources no privileged or confidential information With respect to discussion of indictments and/or civil FCA allegations, these involve allegations of wrongful conduct and are not themselves proof In each of the civil settlements, the company s have denied wrongdoing and the settlements do not include admissions of liabilities The purpose of today s discussion is to describe and analyze theories of liability/risks (and potential defenses and mitigation strategies) not to judge or criticize the conduct of any particular company PCF: Trends in Pharma Enforcement & Compliance 3
FCA Complaint Forest Laboratories PCF: Trends in Pharma Enforcement & Compliance 4
Forest Laboratories (cont d) PCF: Trends in Pharma Enforcement & Compliance 5
Forest Laboratories (cont d) PCF: Trends in Pharma Enforcement & Compliance 6
Forest Laboratories (cont d) PCF: Trends in Pharma Enforcement & Compliance 7
Forest Laboratories (cont d) PCF: Trends in Pharma Enforcement & Compliance 8
Forest Laboratories (cont d) PCF: Trends in Pharma Enforcement & Compliance 9
Forest Laboratories (cont d) PCF: Trends in Pharma Enforcement & Compliance 10
Forest Laboratories (cont d) Activities/evidence regarding off-label and/or inducements promotion: Marketing plans and forecasts Sales force call plans Promotional speakers Advisory boards Clinical study with alleged purpose to switch patients Preceptorships Ghostwriting Gifts and entertainment ROI analysis Complaint also makes reference to prior compliance statements by management PCF: Trends in Pharma Enforcement & Compliance 11
FCA Complaint in U.S. v. Scios Filed June 11, 2009 Focuses on Natrecor (approved IV treatment for acute decompensated CHF Alleges promotion for serial, scheduled out-patient infusions Qui tam complaint filed in 2005 by former Area Manager PCF: Trends in Pharma Enforcement & Compliance 12
Scios Complaint Overview Activities/evidence regarding off-label promotion: Internal marketing materials discussing the outpatient market, opportunity Sales force calls on outpatient infusion clinics Payments to HCPs for promotional speeches, training on outpatient use, publications on use in outpatient setting Ghostwriting Use of CME to promote off-label use Registry study conducted as a marketing tool Coverage and reimbursement support DOJ refers to company-sponsored studies indicating Natrecor was not effective for serial, out-patient infusions ( 48-54) Discussion of Scios/J&J relationship PCF: Trends in Pharma Enforcement & Compliance 13
Scios Complaint Points to Consider No allegation of false or misleading statements Substantial discussion of coverage and reimbursement activities ( 91-97) PCF: Trends in Pharma Enforcement & Compliance 14
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Insights and Analysis Scrutiny of how companies compile and disclose clinical study results. While often characterized as involving false and misleading communications, many do not involve outright falsehoods; rather, they are premised on communications that are misleading by omission of contrary or negative study data. Despite controversy over prosecution of truthful, non-misleading offlabel promotional activities by manufacturers, DOJ actions generally have focuses allegations of false and misleading statements made with intent to defraud. The Scios complaint is a notable exception, though DOJ may narrow its focus as the case proceeds. Prosecutors are scrutinizing "traditional" sales and marketing practices, including "ghostwriting," reimbursement support activities and interactions with compendia, formulary sponsors, and payor organizations. PCF: Trends in Pharma Enforcement & Compliance 16
Key Take-Aways Given DOJ approach of viewing individual acts (which themselves might not be unlawful) as part of broader scheme to defraud or mislead, compliance and risk strategies should look holistically at categories of activities (and overall product marketing plans/activities) rather than viewing individual activities/programs in isolation Manufacturers should expand compliance programs to cover risk-areas beyond traditional sales and marketing activities. Examples: Full range of clinical research and medical affairs activities, Activities involving coverage, reimbursement and payor interactions Tracking and other mechanisms to ensure on-going compliance with commitments made to FDA (such as in response to Warning or untitled letters, 483 responses, meetings with FDA review personnel). PCF: Trends in Pharma Enforcement & Compliance 17
Compliance Trends Last Year Board Oversight Management Accountability Transparency & Disclosure This Year More Intensity in Each of the Previous Areas Embedded Compliance Collection and Tracking Systems Monitoring and Auditing Responding to Internal Allegations of Misconduct PCF: Trends in Pharma Enforcement & Compliance 18
Compliance Trends Tracking & Monitoring PCF: Trends in Pharma Enforcement & Compliance 19
Compliance Trends Tracking & Monitoring PCF: Trends in Pharma Enforcement & Compliance 20
Internal Tracking & Monitoring Pfizer Serono S-P (2006) Purdue Jazz Cephalon Pfizer Review of Detailing Records (i.e., Verbatims) x x x x x Monitoring and Review of Requests for Off-Label Information Ride-Alongs x x x x x x x x x x Field Supervisor Monitoring x x Speaker Monitoring x x Call Notes and/or Sales Records Review x x Publication Monitoring x PCF: Trends in Pharma Enforcement & Compliance 21 21
Internal Investigations & Remediation PCF: Trends in Pharma Enforcement & Compliance 22 22
Internal Investigations & Remediation PCF: Trends in Pharma Enforcement & Compliance 23 23
Internal Investigations & Remediation PCF: Trends in Pharma Enforcement & Compliance 24 24