FDA Regulatory and Compliance Symposium Industry Collaboration & Interactions with Health Professionals: Can Conflicts of Interest be Properly Managed? Cathryn Clary, MD, MBA Vice President, External Medical Affairs Pfizer Inc

One Company’s Steps to Compliance: Pfizer’s Oversight & Education to Avoid Conflicts of Interest Compliance Structure Compliance Officer Designated Compliance Agents Compliance Committee Part of senior management Periodic reports to board of directors Report change in compliance department (officer and committee) to O.I.G. Must keep count of all colleagues Compliance Officer Designated Compliance Agents Compliance Committee Part of senior management Periodic reports to board of directors Report change in compliance department (officer and committee) to O.I.G. Must keep count of all colleagues Policies, Procedures, and Practices Written Standards - Development, implementation and distribution of the code of conduct Policies and Procedures regarding the operation of the company’s compliance program Written Standards - Development, implementation and distribution of the code of conduct Policies and Procedures regarding the operation of the company’s compliance program TrainingTraining No more than 30 days after a colleague’s start date Yearly review and appropriate update of training materials General training 1-2h/year Specific training 2h/year in relation to the area the covered person is involved with Each trained individual shall certify (electronic or in writing) that he/she has been trained and will abide by the principles covered in the training No more than 30 days after a colleague’s start date Yearly review and appropriate update of training materials General training 1-2h/year Specific training 2h/year in relation to the area the covered person is involved with Each trained individual shall certify (electronic or in writing) that he/she has been trained and will abide by the principles covered in the training Major Areas of Focus Promotional and Products Services Managed Care Contracting Medicaid Rebate Promotional and Products Services Managed Care Contracting Medicaid Rebate

Pfizer Principles for Interactions with Healthcare Professionals Physician – Patient relationship has primacy — all of our activities must enable and support this relationship… Corporate responsibility - contribute in any way we can to improving healthcare Transparency is good

Industry Moving Toward Disclosure of MedEd Grants & Charitable Contributions Pfizer disclosure policy announced June 20 and posted at “Consistent with our commitment to openness and transparency, Pfizer intends to report its medical educational grants and support for medical and patient organizations in the United States, beginning in Pfizer partners with many stakeholders and is working to make sure their views are included as the reporting process is developed and finalized.” Decision to disclose medical education grants made in April 2007

Key Points to Assure Compliance for Consulting Fees and Advisory Boards; Travel Physician consulting services are essential to us as an industry, for both our research and commercial activities  On drug discovery and development  Design and execution of clinical trials  Disease state/Therapeutic area knowledge  Appropriate product use  Many other topics Payment: Fair Market Value and reasonable expenses  “Trips to Maui” not allowed; meetings not to occur at lavish venues Industry moving towards much greater transparency in this area

Drug Samples: Some Facts 58% of prescriptions are dispensed without an accompanying prescription. Physicians report that the ability to utilize samples to allow patients to begin treatment immediately is of value. Another 15% of samples distributes represent subsidized treatment for existing patients. Finally, 27% of samples are distributed to provide patients who have a new Rx with an opportunity to experience the product at no cost. A separate published study shows that nearly half (47%) of patients who receive samples do not have health insurance, compared to only 6% who do not receive samples. “The Sampling Subsidy”, Pharmaceutical Executive, ImpactRx analyzed the sampling behavior of its panel of 3,000 high-volume prescribing primary care physicians and specialists. The company collected and analyzed extensive longitudinal sample usage data across thirteen therapeutic categories. Source: Journal of the American Board of Family Practice, September/October 2002 cited in Pfizer Economic Realities in Healthcare Policy, “Creating Access to Innovation”, 2003.

Eliminating Samples May Cause Unintended Consequences It would eliminate a tool that is frequently being used to defray costs for uninsured patients and reduce the cost of therapy for patients. [1] Physicians report that “patient’s financial situation” is a considerable or strong influence in their decision to distribute free samples 86% of the time and a patient’s insurance status is of influence 63% of the time. [2] It would eliminate an opportunity to begin/provide immediate treatment for patients at no cost. It would increase the cost to patients of starting new therapy, which may make it harder for physicians to find the right treatment for patients and get them to comply with it. [1] Any institution that curtails sampling may need to find ways to deliver this service in other ways, which is presumably not without cost. [2] Spiller L, Wymer W. “Physicians’ perceptions and uses of commercial drug information sources: An examination of pharmaceutical marketing to physicians.” Health Marketing Quarterly. 2001; 19(1):91-106, 2002 cited in Pfizer Economic Realities in Healthcare Policy, “Creating Access to Innovation”, 2003.

COI Concerns Around Research Design  Commercial considerations could influence design of study Conduct  Interest in positive outcome could influence recruitment of patients or conduct of study  Excessive payments to investigators could influence data recording (fraud) Communication of Results  Cherrypicking positive data  Failure to disclose full results of studies in timely fashion

Pfizer Policies and Practices Address COI Concerns Design  Handle through Advisory Board meetings; academic consultation; Steering Committees for large trials  All protocols must be approved by IECs/IRBs Conduct  All under International Conference of Harmonization GCP guidelines  Multisite studies in general which can decrease influence of any individual investigator.  Close monitoring for QA. Rigorous procedures to guard against falsification of data  Independent DSMBS for large studies & studies with vulnerable populations Communication of Results  Registration on ClinicalTrials.gov  Disclosure of results on ClinicalStudyResults.org  A priori analysis plans; post-hoc analyses clearly identified