Download Cathryn Clary, MD, MBA Vice President, External Medical Affairs

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
Policies,
Procedures, and
Practices
Training
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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
• Written Standards - Development, implementation and
distribution of the code of conduct
• Policies and Procedures regarding the operation of the
company’s compliance program
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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
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
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
Fees and Advisory Boards; Travel
 Physician consulting services are essential to us as
an industry, for both our research and commercial
activities
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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, 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
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.