FDA Regulatory and Compliance Symposium Industry Collaboration

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FDA Regulatory and Compliance SymposiumIndustry
Collaboration Interactions with Health
Professionals Can Conflicts of Interest be
Properly Managed? Cathryn Clary, MD, MBAVice
President, External Medical Affairs Pfizer Inc
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One Companys Steps to Compliance Pfizers
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

Major Areas of Focus
Policies, Procedures, and Practices

• Written Standards - Development, implementation
  and distribution of the code of conduct
• Policies and Procedures regarding the operation
  of the companys compliance program

• Promotional and Products Services
• Managed Care Contracting
• Medicaid Rebate

Training

• No more than 30 days after a colleagues 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

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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

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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

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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

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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.

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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 patients financial
  situation is a considerable or strong influence
  in their decision to distribute free samples 86
  of the time and a patients 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.

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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

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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