GREAT EXPECTATIONS: WHAT ENHANCED OBLIGATIONS IN RECENTS CIAS AND DPAS SAY ABOUT AGENCY EXPECTATIONS FOR COMPLIANCE PROGRAMS
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1 GREAT EXPECTATIONS: WHAT ENHANCED OBLIGATIONS IN RECENTS CIAS AND DPAS SAY ABOUT AGENCY EXPECTATIONS FOR COMPLIANCE PROGRAMS Pharmaceutical Regulatory and Compliance Congress November 6, 2012
2 AGENDA Context Recent CIAs and DPAs Compliance Monitoring Best Practices Board and Management Certifications Role of Compliance Experts/Consultants/Monitors Other Enhanced Obligations
3 Healthcare Compliance Programs: Building Blocks 1978 Inspector General Act 1987 Federal Sentencing Guidelines 1997 HHS Health Care Fraud and Abuse Control Program 1998 OIG Compliance Program Guidance for Hospitals 2002 Enron, then SOX 2003 OIG Compliance Program Guidance Pharmaceutical Manufacturers 2000s 2000s 2000s Proliferation of CIAs OIG Dashboards and Roundtables Manufacturing Industry Compliance Guidance PhRMA & AdvaMed 3
4 Compliance: Where We ve Been CIAs Evolve Over 1000 CIAs since mid-1990s In 1994, First CIAs Focused On Training and Education Requirements Over 350 Active CIAs Current State-Of-Art CIAs Merck Abbott Labs GSK 4
5 Key Enhanced CIA Provisions Management Certifications Compliance Experts/Outside Consultants Compensation Policies Transparency in Authorship of Journal Articles GMP Issues Cooperation Provisions 5
6 Context Recent CIAs And DPAs Places Where Enhanced Obligations are Appearing CIAs DPAs and NPAs Plea Agreements State Settlements Consent Decrees And Reappearing... 6
7 Context Recent CIAs And DPAs August 1, 2012 OPDP Untitled Letter to Forest (Daliresp) 7
8 Context Recent CIAs And DPAs FDA s Role in Compliance Efforts Independent activities Collaborative activities 8
9 Trends in Field Monitoring Trend 1: Increasingly Uniform Monitoring Approaches Due to CIA Requirements, Similar Monitoring is Conducted by Multiple Companies Live Monitoring Speaker Programs Field Ride Alongs Records Review Call Notes Verbatims
10 Trends in Field Monitoring Trend 2: Using Risk Assessments to Target Monitoring Resources Risk Assessment Approaches Can Help Target: Therapeutic Areas Products Geographies PQA Promotional Quality Assurance
11 Trends in Field Monitoring Trend 3: Consolidating and Analyzing Findings Across Data Sources Call Notes Speaker Programs Unified Monitoring Perspective T&E
12 Key Discussion Questions What s working well and what s working poorly? What are the pros and cons of electronic versus live monitoring? How can effectiveness be maintained after field force is aware of monitoring? How can companies avoid representative use of personal and other media? How can targeting be optimized? Should monitoring be expanded to additional roles (e.g., field medical)?
13 Board and Management Certifications Board of Directors/BOD Compliance Committee The Board shall be responsible for the review and oversight of matters related to compliance with Federal health care program requirements, FDA requirements, and the obligations of this CIA/DPA Requirements: Make a reasonable inquiry into Compliance Program operations to determine: The performance of the Compliance Officer and the compliance personnel To the best of its knowledge, an effective Compliance Program has been implemented to meet requirements and obligations of the agreement If unable to provide such a conclusion in the resolution, a written explanation of the reasons why it is unable to provide the conclusion and the steps it is taking to implement an effective Compliance Program Outcomes: Enhanced focus on details of oversight Focus on full resolution of all IRO/Advisor/Monitor recommendations
14 Board and Management Certifications Management Certifications..certain officers or employees (Certifying Employees) are: specifically expected to monitor and oversee activities within their areas of authority and shall annually certify that the applicable business unit is compliant with applicable Federal health care program(fhcp) and FDA requirements and with the obligations of this agreement Requirements: Trained on and understand the compliance requirements for areas under supervision. Ensure compliance for functional area responsibilities Steps have been taken to promote such compliance To the best of my knowledge, except as otherwise described herein, the functional areas is in compliance with all applicable FHCP, FDA requirements and the obligations of the agreement If unable to provide conclusion for certification, the Certifying Employee shall provide a written explanation of the reasons why he or she is unable to provide the certification and the steps being taken to address the issue(s) identified in the certification. I understand that this certification is being provided to and relied upon by the United States. Outcomes: Certifying employee focus on elements of effective compliance program, improvements AND culture
15 Role of Compliance Experts/Consultants/Monitors Competence The Advisor shall: assign individuals to conduct the Reviews who have expertise in the pharmaceutical/biotechnology/device industry and have expertise in applicable Federal health care program and FDA requirements Understanding of Requirements Perform each component of each Review in accordance with the specific requirements of the agreement ; Follow all applicable Federal health care program and FDA requirements in making assessments in the review If in doubt of the application of a particular Federal health care program or FDA requirement, request clarification from the appropriate authority INDEPENDENT Assessment and Reporting Respond to all OIG inquiries in a prompt, objective, and factual manner; and Prepare timely, clear, well-written reports that include all the information Provide recommendations and company responses in reports
16 Role of Compliance Experts/Consultants/Monitors: Recommendations and Company Responses Once recommendations are identified by IRO/Monitor/Board Advisor, they must be understood by the business to plan a response, tracked, reported and assessed for adequate completion. Recommendations Status Report 2011 CIA First Reporting Period Systems Review (IRO) Open 12 Resolved CIA First Reporting Period Transactions Review (IRO) Open 8 Resolved BOD Compliance Program Effectiveness Review (Board Advisor) Open 7 Resolved 5 Date Issue Summary Response Business Compliance Status Target Owner Owner
17 THANK YOU
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