A%20Focus%20on%20CME%20and%20Grants

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A Focus on CME and Grants

• Nancy Coddington, PhD
• Senior Director, Compliance Operations
  AstraZeneca Pharmaceuticals LP
• And
• Terry Hisey
• Deputy Managing Principal for
• Life Sciences and Healthcare
• Deloitte Consulting

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Disclaimer

• The information presented represents the opinions
  of the authors and does not necessarily reflect
  the views of AstraZeneca Pharmaceuticals LP or
  Deloitte Touche LLP

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Topics Discussed

• Review of business practices that can create
  off-label risk
• Standards and guidelines governing CME and grants
• Factors to consider in risk management of CME and
  grants

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Business Practices That Can Create Off-Label Risk

• Sales representative activities
• Field medical activities
• Reprint use
• Third party relationships
• Pharmacy benefit manager/GPO interactions
• Use of Consultants

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Business Practices That Can Create Off-Label Risk
(continued)

• Use of Speakers
• Clinical research grants
• Publications
• Sampling Activity
• Continuing Medical Education

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CME Conundrum

• Physicians are required to earn CME credits to
  maintain their certification
• In 2003, over half of the funding for CME
  programs was derived from commercial support
• Result increased scrutiny of CME eventsbut also
  increased guidance to improve quality

Murray Kopelow, ACCME at the International
Pharmaceutical Compliance Summit, Philadelphia,
March 2005
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Quotes from Neurontin Case Coverage

• The Justice Department said in its filing
  backing the whistle-blower that a medical
  education program sponsored by Parke-Davis was
  actually a massive promotion of Neurontin for
  pain.

The Pharmaceutical Corporate Compliance Report
9/2/03
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Standards for CME and grants

• FDA Guidance on Industry-Supported Scientific and
  Educational Activities
• ACCME Standards for Commercial Support
• PhRMA Code on Interactions with Healthcare
  Professionals
• OIG Compliance Program Guidance for
  Pharmaceutical Manufacturers

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FDA Guidance on Industry-Supported Scientific And
Educational Activities

• FDA does not regulate as labeling and advertising
  independent scientific and educational events or
  enduring materials funded by industry
• FDA published 12 factors to be used in evaluating
  program independence

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FDA 12 Factors

• Control of Content and Selection of Presenters
  and Moderators
• Disclosures
• Focus of the Program
• Relationship between the Provider and the Company
• Provider Involvement in Sales or Marketing
• Providers Demonstrated Failure to Meet Standards

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FDA 12 Factors

• Multiple Presentations
• Audience Selection
• Opportunities for Discussion
• Dissemination
• Ancillary Promotional Activities
• Complaints

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ACCME Standards for Commercial Support

• Standard 1 Independence
• Standard 2 Resolution of Personal Conflicts of
  Interest
• Standard 3 Appropriate Use of Commercial Support
• Standard 4 Appropriate Management of Associated
  Commercial Promotion

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ACCME Standards for Commercial Support, (cont.)

• Standard 5 Content and Format without Commercial
  Bias
• Standard 6 Disclosures Relevant to Potential
  Commercial Bias

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PhRMA Code

• Third-Party Educational or Professional Meetings
• Acceptable for companies to support
  educational/scientific events
• Financial support for travel,lodging or time
  spent at conference for attendees (I.e., not
  presenters) may not be offered
• Modest meals and receptions may be provided
  either through the grant or may be directly
  provided according to the sponsoring
  organizations guidelines

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OIG Guidance

• Educational grants
• May be appropriate for companies to fund
• Anti-kickback concerns
• Inappropriate marketing concerns
• Independence concerns

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OIG Guidance/California law

• Considerations for decreasing risk
• Separate decisions for grant funding from Sales
  and Marketing
• Establish clear criteria for funding tied to
  educational objectives not to increased sales
• No control over speakers or content of program
• Document and monitor!

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Factors to Consider in Risk Management

• Changes in processes and procedures for
• Company
• Accrediting providers
• Vendors

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Company decisions

• Do we want to continue our commitment to
  healthcare provider independent education?
• If yes, what policies/SOPs should be changed to
  ensure lack of company influence on educational
  program?
• Where and how will documentation of review and
  approval be housed?

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Company decisions

• What is our definition of separation of the
  grant making functions from Sales and Marketing?
• How are we going to monitor adherence to our SOPs
  and policies for CME and educational grants?
• What is an appropriate governance model for a
  company for management of CME and educational
  grants?

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Accrediting provider decisions

• Are we willing to expend more energy than in the
  past to create a robust proposal (with needs
  assessments, learning objectives, etc.) to submit
  for company funding?
• Are we willing to create and implement a rigorous
  Conflict of Interest process?

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Accrediting provider decisions

• Are we willing to evaluate the effectiveness of
  the learning for our programs and our
  MedEd/MedComm partners?

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Vendor decisions

• Are we willing to create a firewall or even
  separate companies for promotional programs vs.
  independent education?
• Are we willing to cut our ties with the Marketing
  arms of companies when designing independent
  educational programs?

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Vendor decisions

• Are we willing to create bona fide and robust
  needs assessments for programs for which we are
  seeking company support?
• Are we willing to work with a more diverse set of
  thought leaders as we plan educational events?

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Summary

• There has been concern among government agencies
  and accrediting providers that independent
  education programs may be used inappropriately
  for the dissemination of marketing messages
• A number of guidances and standards have been
  released recently to ensure that CME and other
  independent educational programs are free from
  company influence

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Summary

• Adherence to new guidelines and standards
  requires behavior changes on the part of all
  involved with independent education