Transparency in Grants and Gifts

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

2. Evolving Environment 2002 • PhRMA Code on Interaction with Health Care Professionals 2003 • OIG HHS Compliance Program Guide for Pharmaceutical Manufacturers • AdvaMed Code of Ethics on Interactions with Health Care Professionals 2004 • ACCME Updated Standards for Commercial Support • Conjoint Committee CME Task Force Recommendations 2006 • Pfizer created Medical Education Grants Group in Medical • ACCME Revised Accreditation Standards 2007 • Senate Finance Committee Report on Use of Educational Grants by Pharmaceutical Manufacturers P4238 - US EMA Op Plan

3. Accelerating Pace of Scrutiny 2008 • 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 P4238 - 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) P4238 - 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 P4238 - US EMA Op Plan

6. 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. Pfizer Transparency Efforts 2002 2004 2006 April 2007 June 2007 May 14, 2008 P4238 - 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 P4238 - 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 P4238 - 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 P4238 - 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 P4238 - 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 P4238 - US EMA Op Plan

12. Questions? P4238 - US EMA Op Plan