A Focus on CME and Grants
Nancy Coddington, PhDSenior Director, Compliance Operations
AstraZeneca Pharmaceuticals LP
AndTerry 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