A Focus on CME and Grants

1. 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

2. 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

3. 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

4. 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

5. Business Practices That Can Create Off-Label Risk (continued) • Use of Speakers • Clinical research grants • Publications • Sampling Activity • Continuing Medical Education

6. 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 events…but also increased guidance to improve quality *Murray Kopelow, ACCME at the International Pharmaceutical Compliance Summit, Philadelphia, March 2005

7. 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

8. 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

9. 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

10. 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 • Provider’s Demonstrated Failure to Meet Standards

11. FDA 12 Factors • Multiple Presentations • Audience Selection • Opportunities for Discussion • Dissemination • Ancillary Promotional Activities • Complaints

12. 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

13. ACCME Standards for Commercial Support, (cont.) • Standard 5: Content and Format without Commercial Bias • Standard 6: Disclosures Relevant to Potential Commercial Bias

14. 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

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

16. 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!

17. Factors to Consider in Risk Management • Changes in processes and procedures for • Company • Accrediting providers • Vendors

18. 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?

19. 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?

20. 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?

21. Accrediting provider decisions • Are we willing to evaluate the effectiveness of the learning for our programs and our MedEd/MedComm partners?

22. 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?

23. 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?

24. 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

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