FDA Regulatory and Compliance Symposium

Industry Collaboration & Interactions with Health Professionals: Can Conflicts of Interest be Properly

Managed?

Cathryn Clary, MD, MBAVice President, External Medical Affairs

Pfizer Inc

One Company’s Steps to Compliance: Pfizer’s One Company’s Steps to Compliance: Pfizer’s Oversight & Education to Avoid Conflicts of Interest Oversight & Education to Avoid Conflicts of Interest

Compliance Compliance StructureStructure

• 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, Policies, Procedures, and Procedures, and

Practices Practices

• 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

Major Areas of Major Areas of FocusFocus

• Promotional and Products Services

• Managed Care Contracting

• Medicaid Rebate

Pfizer Principles for Interactions with Healthcare Pfizer Principles for Interactions with Healthcare ProfessionalsProfessionals

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 Industry Moving Toward Disclosure of MedEd Grants & Charitable ContributionsGrants & Charitable Contributions

Pfizer disclosure policy announced June 20 and posted at

www.pfizermededgrants.com

“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 2008. 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 Key Points to Assure Compliance for Consulting Fees and Advisory Boards; TravelFees 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 FactsDrug 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, 2005. 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 Eliminating Samples May Cause Unintended ConsequencesConsequences

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.