Transparency inGrants and Gifts

Pfizer Approach

Cathryn Clary, MD VP, US External Medical Affairs

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Evolving Environment

PhRMA Code on Interaction with Health Care Professionals2002

OIG HHS Compliance Program Guide forPharmaceutical Manufacturers

AdvaMed Code of Ethics on Interactions with HealthCare Professionals

2003

ACCME Updated Standards for Commercial Support Conjoint Committee CME Task Force Recommendations2004

Pfizer created Medical Education Grants Group in Medical ACCME Revised Accreditation Standards2006

Senate Finance Committee Report on Use of Educational Grants byPharmaceutical Manufacturers2007

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Accelerating Pace of Scrutiny

Macy Foundation Recommendations on ContinuingEducation in the Health Professions

Senate Finance Committee association inquiryletter

Senator Grassley letter to major pharmaceuticalcompanies (Feb 26, 2008)

AAMC Task Force reports on industry support ofeducation

CEJA AMA report

IOM conflict of interest report anticipated

Sunshine Act legislation introduced in Congress

2008

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Industry Response to MoveTowards 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)

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Opportunities Are Inherent inGreater Transparency

Enhance understanding of pharmaceutical industrycommitment and responsiveness

Broaden visibility of industry partnerships andcollaborations with other healthcare groups toadvance health

Promote trust

Mediate skepticism and cynical perception of industry

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Pfizer Transparency Efforts

Pfizer begins publicly reporting its U.S. political contributions.

Pfizer begins registering trials on clinicaltrials.gov (> 800 trialsregistered to date).

Pfizer begins publicly posting clinical trial results onclinicalstudyresults.org. As of 2005, results of all patient studies(Phase I and beyond) are posted.

Pfizer begins disclosing information on its drug developmentpipeline on Pfizer.com.

Pfizer begins reporting its U.S. post marketing commitments onPfizer.com.

Pfizer announces intention to disclose its grants & charitablecontributions.

Pfizer begins reporting its grants & charitable contributions onPfizer.com.

2002

2004

2006

April 2007

May 14, 2008

June 2007

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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 commitmentto transparency

Descriptions of FundingTypes and RecipientOrganizations

Frequently Asked Questions Statement on Transparency in

Grants

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What Are We Disclosing?

Grants ≥$500 to U.S. medical, scientific and patientorganizations

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

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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 BethIsrael Deaconess Medical Center $237,500 to Massachusetts Institute of Technology

New York Hispanic/Latino Outreach Program $100,000 to Patient Advocate Foundation

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Response to Publication of Grantand 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 thisissue.” – National Health Council

“Thank you for the opportunity to publicly endorse Pfizer’s newtransparency policy and grant activity posting. You, your colleaguesand 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

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What’s Next?

Operationalizing process and securing resources tosustain the effort

Considering standardized customer-facing websites tofacilitate 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

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Questions?