Transparency in Grants and Gifts Pfizer Approach Cathryn Clary, MD VP, US External Medical Affairs.

Slides:



Advertisements
Similar presentations
Professional Education Support Wyeth Pharmaceuticals Melinda Somasekhar, PhD.
Advertisements

FUNCTION OF MEDICAL COUNCIL AND ITS IMPORTANCE IN PPP PROMOTION H.E. Professor Thir Kruy, Secretary of State, MoH President of MCC Intercontinental Hotel.
National and Institutional Guidelines on Conflict of Interest in Physician-Industry Relationships Rev. 10/21/2014 APGO Interaction with Industry: A Medical.
BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. What.
Marketing to Doctors – Payments for Loyalty Julie Brill Assistant Attorney General Vermont Attorney General ’ s Office Montpelier,
Pharmaceutical Compliance Congress: “State of the States” October 27, 2008 Janice G. Cunningham Jeffrey L. Handwerker.
NCI Designation: Expanding Science and Promoting Health in the Region Name Title, Company Date.
1 Physician-Industry Transparency: The U.S. Physician Payment Sunshine Act.
Reinventing Medical Education Marissa Seligman, PharmD VP & Compliance Officer Pri-Med Institute, Boston, MA June 7, 2005.
Conflict of Interest. Definition  “A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise.
Good Clinical Practice GCP
Health Science/Research Policy Group II. Problem Statement Safety and effectiveness of prescription drugs in a real-world environment are uncertain because.
Teaching Professionalism to Residents: The Management of Conflict of Interest in Medicine NORMAN B. KAHN, JR. MD COUNCIL OF MEDICAL SPECIALTY SOCIETIES.
Open Payments Act AKA the ‘Sunshine Act’ Open Payments Act AKA the ‘Sunshine Act’ Public Postings of Physician Ownership, Investments, & Transfers of Value.
Role of Industry in Clinical Care, Research and Education Rev 10/21/2014 APGO Interaction with Industry: A Medical Student Guide.
VCU School of Medicine Policy on Industry Relations Effective July 1, 2009.
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.
Running for Public Office A Nurse’s Perspective Evelyn D. Quigley, MN, RN Saturday, January 17,
Overview: FY12 Strategic Communications Plan Meredith Fisher Director, Administration and Communication.
Introduction to the CCNAP Clinical Guidelines Initiative Council on Cardiovascular Nursing and Allied Professions.
Pitfalls and Lessons Learned: Advanced Implementation Strategies for a Compliant Grant Process National CME Audioconference December 9, 2008.
Will Disclosure Quiet the Industry’s Critics? Peter Lurie, MD, MPH Deputy Director Health Research Group at Public Citizen Presented before The National.
Disclosures No relationships or conflicts to report.
International Congress and Convention Association International Association Overview Ross Robinson 44 th ICCA Congress & Exhibition, Monday, November 7.
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.
+ National and Institutional Guidelines on Conflict of Interest in Physician-Industry Relationships.
A Focus on CME and Grants Nancy Coddington, PhD Senior Director, Compliance Operations AstraZeneca Pharmaceuticals LP And Terry Hisey Deputy Managing Principal.
D.Zucker Draft-EB09 Ethics & Academic Technology Transfer: Patients, Products and Public Trust Deborah Zucker, MD, PhD, Tufts Medical Center.
Why Ethical Fundraising Matters Karen Alebon October 23, 2008.
1 Kathleen Gallo, PhD, MBA, RN,FAAN Writing Team Member 13 th Report to Congress.
+ Role of Industry in Clinical Care, Research, and Education.
An Educational Session on HSC OP 10.27, Health Care Vendor Interactions April 20, 2009.
1 Harvard University Cambridge, MA March 29, 2007 Medical Device Congress AdvaMed’s Efforts to Promote Compliance Christopher L. White, Esq. Executive.
NJE rnicHR1 This report is solely for the use of client personnel. No part of it may be circulated, quoted, or reproduced for distribution.
Copyright © Harvard Medical School. All Rights Reserved. Outside Activity Report: What Do I Need to Report?
Insuring America’s Health: Principles and Recommendations An Institute of Medicine Report Presented By Shoshanna Sofaer, Dr.P.H. School of Public Affairs,
Sara Lovell, CPCS Education Coordinator Providence Alaska Medical Center.
ROPES & GRAY LLP The Compliance Environment and Grant Process: Oversight and Response in the Pharmaceutical Industry Howard L. Dorfman December 9, 2008.
Graduate Medical Education Failing Primary Care Bob Phillips, MD MSPH Vice Chair, COGME June 9, 2008.
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.
Working with Non-Governmental Agencies: Our African Experience Dr Jack Watters Vice President External Medical Affairs, International Pfizer (EMAI)
FDA Regulatory and Compliance Symposium Industry Collaboration & Interactions with Health Professionals: Can Conflicts of Interest be Properly Managed?
Stakeholder Engagement for Patient-Centered Outcomes Research Vanessa Jacoby, MD, MAS Associate Professor Obstetrics, Gynecology, and Reproductive Sciences.
1 Compliance vs. the Law Department: How to Work Together Michael Dusseau Senior Director, Compliance North America Schering-Plough David Ralston, Esq.
Greg Levine. January 9, Enforcement Environment  Accelerating progression of off-label promotion cases – Not just “Big Pharma” – No “oncology exception”
1 Global Codes of Ethics/Conduct Roundtable Discussion International Medical Device Compliance Congress and Best Practices Forum May 27, 2008 Paris Christopher.
Rheumatology Mastery in Ankylosing Spondylitis
Disclosure UK Talking about Transparency.
GCP/QA SIAC Member Meeting 19 January 2007 Pamela Rose, Session Chair
Hematopoietic Cell Transplantation: Moving Beyond Survival to the Patient’s Perspective Linda J Burns, MD Medical Director, NMDP/Be The Match Health.
Learning Session 2 Welcome Back! – DAY TWO
Disclosure UK Talking about Transparency.
Pulmonary Rehabilitation and Readmission
Heart Failure Management
The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress Beyond the DOJ: Compliance Best Practices in the Orthopedic Environment.
Can Mobile Technology Improve Outcomes?
CME and Consultants Compliance Roundtable
Lilly Grant Funding Disclosure May 27, 2008
AGREEMENT FOR TRANSPARENCY The Case of Mexico
California’s “Comprehensive Compliance Program” Law
Disclosure of Faculty Conflict of Interest
FDA Sentinel Initiative
Webinar: Advanced Implementation Strategies for a Compliant Grant Process The Tipping Point: Incrementalism Need not Apply December 9, 2008 Mike Saxton,
Updates to the PhRMA Code on Interactions with Healthcare Professionals National Pharma Audioconference August 5, 2008.
Title of Program: Medicine Grand Rounds Title of Talk: Health Services Research: Methods,
Title of Program: Medicine Grand Rounds Title of Talk: Morbidity & Mortality Speaker/Moderator:
Title of Program: Medicine Grand Rounds Title of Talk: Morbidity & Mortality Speaker/Moderator:
Presentation transcript:

Transparency in Grants and Gifts Pfizer Approach Cathryn Clary, MD VP, US External Medical Affairs

09/24/2007 – 7:30pm P US EMA Op Plan 2 Evolving Environment PhRMA Code on Interaction with Health Care Professionals 2002 OIG HHS Compliance Program Guide for Pharmaceutical Manufacturers AdvaMed Code of Ethics on Interactions with Health Care Professionals 2003 ACCME Updated Standards for Commercial Support Conjoint Committee CME Task Force Recommendations 2004 Pfizer created Medical Education Grants Group in Medical ACCME Revised Accreditation Standards 2006 Senate Finance Committee Report on Use of Educational Grants by Pharmaceutical Manufacturers 2007

09/24/2007 – 7:30pm P US EMA Op Plan 3 Accelerating Pace of Scrutiny Macy Foundation Recommendations on Continuing Education in the Health Professions Senate Finance Committee association inquiry letter Senator Grassley letter to major pharmaceutical companies (Feb 26, 2008) AAMC Task Force reports on industry support of education CEJA AMA report IOM conflict of interest report anticipated Sunshine Act legislation introduced in Congress 2008

09/24/2007 – 7:30pm P US EMA Op Plan 4 Industry Response to Move Towards Greater Transparency Now established:  FDA financial disclosure (longstanding)  Clinical trial registration (FDAAA expanded remit)  Clinical trial results (FDAAA drastically expanded remit)  Compound pipelines Emerging:  Post-marketing commitments (Pfizer)  Greater transparency about safety information  Payments for continuing medical education and to patient associations and medical groups (Eli Lilly, Pfizer, others following shortly)

09/24/2007 – 7:30pm P US EMA Op Plan 5 Opportunities Are Inherent in Greater Transparency Enhance understanding of pharmaceutical industry commitment and responsiveness Broaden visibility of industry partnerships and collaborations with other healthcare groups to advance health Promote trust Mediate skepticism and cynical perception of industry

09/24/2007 – 7:30pm P US EMA Op Plan 6 Pfizer Transparency Efforts Pfizer begins publicly reporting its U.S. political contributions. Pfizer begins registering trials on clinicaltrials.gov (> 800 trials registered to date). Pfizer begins publicly posting clinical trial results on clinicalstudyresults.org. As of 2005, results of all patient studies (Phase I and beyond) are posted. Pfizer begins disclosing information on its drug development pipeline on Pfizer.com. Pfizer begins reporting its U.S. post marketing commitments on Pfizer.com. Pfizer announces intention to disclose its grants & charitable contributions. Pfizer begins reporting its grants & charitable contributions on Pfizer.com April 2007 May 14, 2008 June 2007

09/24/2007 – 7:30pm P US EMA Op Plan 7 Web Page: Under ‘Responsibility’ Tab on Pfizer.com Description of grants:  Name of recipient organization  Project description / title  Amount of payment Data published quarterly Explanatory text:  Home Page, describing scope of data and commitment to transparency  Descriptions of Funding Types and Recipient Organizations  Frequently Asked Questions  Statement on Transparency in Grants

09/24/2007 – 7:30pm P US EMA Op Plan 8 What Are We Disclosing? Grants ≥$500 to U.S. medical, scientific and patient organizations Charitable contributions ≥$500 Examples include:  Medical Education Group grants  Fellowship/scholarship support to institutions (not individuals)  Grants/contributions to patient organizations  Grants/contributions to medical & scientific associations  Grants/contributions to academic and other medical centers  Link to Pfizer Foundation IRS 990 filings

09/24/2007 – 7:30pm P US EMA Op Plan 9 Illustrative Key Contributions: 1Q 2008 ‘CS2day’ (Medical Education)  3-year HCP education initiative to reduce smoking and improve public health  $3.4 million to California Academy of Family Physicians and 8 partner organizations nationwide Malaria patient education and treatment  $500,000 to Family Health International Clinical Investigator Training Program with MIT and Beth Israel Deaconess Medical Center  $237,500 to Massachusetts Institute of Technology New York Hispanic/Latino Outreach Program  $100,000 to Patient Advocate Foundation

09/24/2007 – 7:30pm P US EMA Op Plan 10 Response to Publication of Grant and Gift Disclosure Media:  Coverage by Bloomberg, industry media, and blogs generally positive “The Pfizer transparency initiative should be a model for industry.” – Mark Senak, Eye on FDA blog Recipient Organizations:  100% supportive response after notification of ~750 recipient organizations “You have all done a tremendous job putting this together, congratulations. We look forward to working with you all on this issue.” – National Health Council “Thank you for the opportunity to publicly endorse Pfizer’s new transparency policy and grant activity posting. You, your colleagues and organization are to be commended.” – Easter Seals Within Pfizer: “Detailing these grants and charitable contributions is an important part of our ongoing transparency drive.” – Jeffrey Kindler, Chairman & CEO

09/24/2007 – 7:30pm P US EMA Op Plan 11 What’s Next? Operationalizing process and securing resources to sustain the effort Considering standardized customer-facing websites to facilitate grant and contribution applications Discussing potential expansions in scope of project:  Grants and charitable contributions to non-patient, non- medical, non-scientific organizations  U.S. initiative establishes momentum for Pfizer ex-U.S. transparency efforts

09/24/2007 – 7:30pm P US EMA Op Plan 12 Questions?