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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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!

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

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?

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?

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?

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

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?

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?

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

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