Lilly Grant Funding Disclosure May 27, 2008

Slides:



Advertisements
Similar presentations
Gakava L Roche Products Ltd., Welwyn, UK
Advertisements

The Role of Government in Encouraging a High Standard of Ethics in the Healthcare Sector: Indonesia Experience Prof. Agus Purwadianto Senior Adviser to.
Professional Education Support Wyeth Pharmaceuticals Melinda Somasekhar, PhD.
PwC Medical Device Compliance Survey Discussion of Survey Results.
Pharmaceutical Compliance Current Trends: Hot Button Issues to Look at this Year in Sales, Marketing, Clinical, Medical Affairs and Government Pricing.
Pharmaceutical Compliance Congress: “State of the States” October 27, 2008 Janice G. Cunningham Jeffrey L. Handwerker.
1 Physician-Industry Transparency: The U.S. Physician Payment Sunshine Act.
MONITORING THE VALUE OF TRIAL REGISTER INFORMATION Thomson Pharmaceutical Services LAWRENCE LIBERTI MS, RPh, RAC JULY 16, 2008.
Good Clinical Practice GCP
Clinical Compliance Programs: Investigator Payments, GCPs, and More…. Teri Crouse, J.D. Director of Compliance for Healthcare & Marketing.
The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Compliance Best Practices in a Post Orthopedic Environment David Matyas.
# Operating Under the New Compliance Environment: Considerations for the Pharmaceutical Industry The Impact of the new Medicare Prescription Drug benefit.
Introductory training Medical Technology Industry Code of Practice.
Voluntary Codes MassMEDIC Meeting Are You Ready to Comply with Massachusetts’ New Pharmaceutical and Medical Device Code of Conduct Law? Linda D. Bentley,
© 2008 Foley Hoag LLP. All Rights Reserved. 1 The New Massachusetts Pharmaceutical & Medical Device Marketing Regulations How to Address and Overcome Likely.
Industry Perspective on Challenges for Product Developers - Drugs Christine Allison, M.S., RAC Associate Regulatory Consultant, Global Regulatory Affairs.
Pitfalls and Lessons Learned: Advanced Implementation Strategies for a Compliant Grant Process National CME Audioconference December 9, 2008.
CLINICAL RESEARCH STUDIES Janette Hannam, MS, CTRA Asst. Director for Research, OSP.
Health and Safety Policy
Transparency in Grants and Gifts Pfizer Approach Cathryn Clary, MD VP, US External Medical Affairs.
Vendor Relations Policy. Why Is There A Policy? The Patient Protection and Affordable Care Act was signed into law March 23, The new law contains.
A Focus on CME and Grants Nancy Coddington, PhD Senior Director, Compliance Operations AstraZeneca Pharmaceuticals LP And Terry Hisey Deputy Managing Principal.
Pre-Conference Questions: Legal/Regulatory & Operational Considerations March 5, 2009.
Session 1.01 US Healthcare Professionals Abroad – Issues and Practical Solutions Caroline West – Senior VP, Chief Compliance and Risk Officer Shire Pharmaceuticals.
The Physician Payments Sunshine Act Legislation Ann Leopold Kaplan October 27, 2008.
Lilly Answers that Matter. Preserving the Value of Industry Interactions with Health Care Professionals Jack Harris, M.D. Vice President, U.S. Medical.
1 Compliance vs. the Law Department: How to Work Together Michael Dusseau Senior Director, Compliance North America Schering-Plough David Ralston, Esq.
Transparency of payments to healthcare professionals: ABPI plans for a central platform for individual disclosures 2016 June 2014.
1 The Implementation of Fair Market Value What can we learn from recent enforcement actions? Debjit Ghosh Life Sciences Advisory Services Huron Consulting.
Responsibilities of Sponsor, Investigator and Monitor
Community of Practice K Lead Project Team: الالتزامالتحفيز التفكير المؤسسي المرونةالتميزالشراكةالاستقامة.
ISO Certification For Laboratory Accreditation ISO Certification For Laboratory Accreditation.
Good Clinical Practice (GCP) and Monitoring Practices
GLOBALG.A.P. Risk Assessment On Social Practice – GRASP
Data Analysis in the Water Industry: A Good-Practice Guide
Disclosure UK Talking about Transparency.
Overview of Plain Language Summary
Responsibilities of Sponsor, Investigator and Monitor
Risk Communication in Medicines
Enrolling in Clinical Trials
How to Apply for and Receive Industry Funding for Investigator Sponsored Research Chuck Simonton MD, FACC, FSCAI Chief Medical Officer Abbott Vascular.
Within Trial Decisions: Unblinding and Termination
General Data Protection Regulations Preparing for the upcoming changes in data protection law David Jones & Angharad Williams.
Disclosure UK Talking about Transparency.
Presented by Robert Ford
Dissemination Workshop for African countries on the Implementation of International Recommendations for Distributive Trade Statistics May 2008,
9/16/2018 The ACT Government’s commitment to Performance and Accountability – the role of Evaluation Presentation to the Canberra Evaluation Forum Thursday,
Pre-Close Rules of Engagement
Grant Transparency and Medical Device Companies
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you.
BRC Packaging ISSUE 5 Global Standard for Packaging and Packaging Materials.
GMD Data Request NERC Rules of Procedure Section 1600
African Centres of Excellence – Satisfaction Survey Results
The EPSO Peer Evaluation of the Danish Health and Medicines Authority
Countdown to Compliance
The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Beyond the DOJ: Compliance Best Practices in the Orthopedic Environment.
CME and Consultants Compliance Roundtable
The partnership principle in the implementation of the CSF funds ___ Elements for a European Code of Conduct.
National Statistician’s Data Ethics Advisory Committee
Core Competencies of a World Class Customer Advisory Board
California’s “Comprehensive Compliance Program” Law
Guidance for Patient Interactions
Jørgen Friis, ETSI VP SES
Enforcement Climate Congressional Oversight U.S. Attorney’s Offices
Updates to the PhRMA Code on Interactions with Healthcare Professionals National Pharma Audioconference August 5, 2008.
EUnetHTA Assembly May 2018.
Process and Procedure Documentation
AUDIT QUALITY REGULATORY FOCUS AREAS
Part II Objectives Describe how policies and procedures are used
APMP Professional Certification
Presentation transcript:

Lilly Grant Funding Disclosure May 27, 2008

Reactions to Publications Grant Funding Publishing Methodology Eli Lilly Philosophy Reactions to Publications Grant Funding Publishing Methodology How to Publish Pre and Post Publication Thoughts 2

What to publish in the future? Public Scrutiny and Press Best Interests of Industry Why publish? What to publish (CME, Charitable, Sponsorship, Clinical Trials, Patient Advocacy)? What to publish in the future? Public Scrutiny and Press Senate Finance Committee Inquiries Why publish?: Create transparency to public Highlight the good programs that Lilly and Pharma support At the time we had two Senate Finance Committee inquiries regarding grant funding and the subject of grant giving by pharma being used for off-label drug promotion was often in the press. Also states were expanding creating broad legislation regarding spending and gifts from Pharma companies to physicians, some of which included the benefit received by physicians for CME programs. Discuss that Lilly was the first to launch a clinical trial registry back in 2005(?) to create greater transparency of their clinical studies and to the quality of those studies. Aggregate Spend and State Law Reporting

Physician Participants Non-Physician Participants Promote Good Work of Pharma Physician Education Other Healthcare Practitioner Education Charitable Contributions ACCME Programs Hours of Instruction Physician Participants Non-Physician Participants Grand Total 93,582 712,163 8,255,017 4,577,078 Hit bullets and then cite ACCME 2006 Annual report statistics regarding number of programs and HCP’s educated Source: ACCME 2006 Annual Report 4 4

Government Press Industry Advocacy Groups Internal Praise from Senator Grassley and Capitol Hill for initiative Consulted on other initiatives (gained added credibility) N/A Clarification what is disclosed Enough disclosure Other data to be disclosed Other Pharma company plans Lilly has no additional plans Positive articles in WSJ, trade press, et. al. N/A Why did Lilly decide to disclose What is the purpose Create Transparency Highlight the good programs Lilly supports Generally positive Companies looking to undertake similar initiatives Moved transparency dialogue to forefront N/A Did Lilly do too much too fast Did Lilly drive the Sunshine Act and other regulations Right information to publish Thought this was the right information to disclose Pros Positive recognition Improve awareness of good programs Improved credibility Additional scrutiny Exposure for smaller groups strains resources N/A Senior management supportive Employees feel good about what company is doing N/A Want more information about programs Ongoing assessment of areas for disclosure and transparency Cons Questions Response 5

Potential Publishing Methodology Technical Challenges Data Repository Approving data for publication Consistency, accuracy of data Controls Separation of divisions (Sales, Marketing, etc.) Following processes and procedures Documentation SOPs LOA language Responses Disclosure Level of detail Responsible party Validity of data Format of disclosure Preparation & Training Whom to train Why train Continuous training Potential Publishing Methodology Discuss new training created and required for all US ee’s narrated by Dr. Alan Breier, VP Medical and Chief Medical Officer Need to ensure all US ee’s understand external regulations regarding grants since grants will be publicly disclosed and understand appropriate interactions with HCP’s and HC organizations regarding grants One US policy on grants and consistent SOP’s in the various areas within the company that give grants Disclosure report process and reviews that occur prior to posting (LGO, legal, Compliance, and Advocacy folks) to ensure information is accurate and has a clear grant description Discuss technical challenges- one grant application for all areas, one process, consistent SOP’s, coordination and communication across grant offices, etc

Publication Experience Positive reactions internally and externally. No challenges from funding recipients Contacting key organizations before publication was beneficial and helped industry perception No noticeable change in provider interaction with Lilly Preparation and training is key to successfully publishing grant information Discussion Items Is disclosing more or less grant detail information better? What has been the government’s reaction? Has the perception of the industry changed? Missing qualitative aspect of our funding. How good was it? How effective was it? Use surveys or other criteria to determine this. 7 7