CME Food and Drug Law Institute Sept 17 2006

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CMEFood and Drug Law Institute Sept 17 2006

• A M Iacono
• J S Smith, MS, PHD, FACME
• M Doyle Scharff, MBA, FACME

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Learning Objectives

• State the significant legal and practical
  differences between promotion (company-directed)
  and independent education
• Describe how the OIG expects pharmaceutical
  companies to structure themselves and how FDA
  expects them to behave when supporting IE
• Summarize the 2007 US Senate report on grants 
• Describe the relevant issues surrounding the new
  ACCME policies
• Integrate one practical change to improve
  compliance in their grant process

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Format

• A combination of presentations, give and take
  between the panel, and questions from the
  audience. Audience questions will be sought
  throughout the program

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Shared Vision Common Understanding of CE and
the rules
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• CME under pressure
• Government, associations, media, blogs,
  healthcare institutions, physicians, others
• Is CE independent if CI funds it?
• Associated with Marketing
• ACCME rules changing

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CME Funding from Pharma Remains
Independent Education Funding Sources
( millions)
68.8
65.8
61.8
65
58.5
52.3
50
of funding from industry sum of commercial
support and advertising/exhibit income Other
Income examples are participant registration
fees, inter-dept. allocations within a provider
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• There is confusion around CE and Promotion, it
  gets fuzzy in the press
• There is confusion around terms, accredited /
  certified

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CE vs. Promotion Independent vs. Controlled
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CME vs. Promotion
AMI attempt at clarification
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Jennifer Spear-Smith, MS, PhD, FACME
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Guidelines, Standards, Codes and Policy

• Dec 1990
• Mar 1992
• Dec 1997
• Jul 2002
• Apr 2003
• Nov 2003
• Jan 2004
• May 2007
• Aug 2007

• AMA Guidelines on Gifts to Physicians
• ACCME Standards for Commercial Support (SCS)
• FDA Final Guidance on CME
• PhRMA Code Interactions with HCPs
• OIG Compliance Program Guidance
• AdvaMed Code
• Revised ACCME SCS
• US Senate Report Ed Grants and Pharma
• ACCME Revised Policies

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US Senate and CME Quick History

• Senators Grassley/Baucus (mostly Grassley) of the
  Senate Finance Committee
• June 2005 Asked 23 big pharma to answer
  questions
• about educational grant processes
• January 2006 Followed up with additional
  questions
• December 2006 Asked ACCME to explain their
  accreditation processes as it relates to
  commercial support

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US Senate Concerns

• Their interest lies in increased costs to
  Medicare
• Pharma routinely uses educational grants to help
  build market share for their newer more lucrative
  products.
• New products cost more, increasing Medicare and
  Medicaid spending
• New products have less history and therefore may
  be less safe
• Particular interest in off-label prescribing
  implications

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US Senate Report Points
Positively noted
Negatively noted

• ..positive trends in pharmas use of
  educational grants.
• ..paying increased attention to educational
  grants.
• ..limiting sales and marketing in grant making
  process.
• adopted policies that on their face do not
  allow for grants to be awarded for unlawful
  purposes.
• This is clearly a step in the right direction.

• Multiple companies have used CME inappropriately
  (Warner Lambert, Serono).
• ..some CME activities are improperly influenced
  by commercial supporters (according to ACCME
  data).
• ..still allow the industry to walk a fine line
  between violating rules prohibiting off-label
  promotion
• The opportunity for abuse remains.

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Reading Between the Lines

• There is probably something illegal going on, but
  we have no evidence and it is hard to tell
  because of the third-party accredited provider
  intermediary.

• Off-label prescribing is always bad.

Jen Smiths/EEAB interpretation - US Senate
Report April 25, 2007
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Perspective

• This is a required report of staff to the
  committee after an inquiry starts.
• This was the 58th Senate report in 2007 at the
  time of release.
• No action items and no legislation are
  recommended.
• Report was not leaked to the press before its
  release and not picked up by the media.

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Grassley, Avandia and CME

• September 12 Update
• Physician Payment Sunshine Act
• Is pharma responsible for reporting CME honoraria?

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Marueen Doyle Scharff, MBA, FACME
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ACCME Revised Policies

• Adding signatures to a written agreement
• An accredited provider can be added as a party to
  a written agreement for commercial support (LOA)
  after the original agreement was executed.
• Regarding written agreements for commercial
  support
• A provider cannot enter into an agreement with a
  commercial supporter where the commercial
  supporter specifies the manner in which the
  provider will fulfill the requirements of the
  ACCMEs Elements, Policies and Standards
• Electronic signatures for LOAs acceptable

"The ACCME believes that CME can receive
commercial support from industry without
receiving any advice or guidance, either nuanced
or direct, on the content of the activity or on
who should deliver that content. -ACCME
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ACCME Revised Policies

• Communicating information to learners
• All required ACCME information must be
  transmitted to learners prior to beginning the
  CME activity (internet, CD-ROM, satellite, etc.)
• CME activity location
• CME activities may not reside on a website owned
  or controlled by a commercial interest
• Journal-based CME
• Defining elements of journal-based CME
• Disclosure, CME content, post-test, evaluation

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ACCME Revised Policies

• Definition of a commercial interest
• Any entity producing, marketing, re-selling or
  distributing health care goods or services
  consumed by, or used on, patients
• Accreditation and credit
• All CME activities developed by a provider
  accredited by the ACCME system and associated
  with AMA PRA Category 1 Credit must be developed
  and presented in compliance with all ACCME
  accreditation requirements and requirements of
  the AMA PRA program.
• Awarding credit for teaching in CME activities

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Stakeholder Issues
 '"In CME, the terms 'industry partners' and
'collaboration with industry' imply a
relationship that is not consistent with the
spirit of independence as articulated in the
ACCME Standards for Commercial Support." -
ACCME

• Definition of a commercial interest
• Parent vs. sister-companies with firewalls
• Technology companies who host CME activities
• Collaboration vs. independence
• the ACCME needs to define a great many
  terms in this policy

Focus Groups
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MDS Perspective

• More questions than answers
• Multiple stakeholder groups seeking guidance from
  ACCME on interpretation, definitions, etc.
• Attempt to bring more structure, clarity to
  Standards for Commercial Support is an extension
  of updates made by ACCME over the past 18 months
  (and a partial response to the SFC inquiry)
• Most providers are OK with the Policy updates
• Many MECCs feel threatened
• Reality and perception continues to drive change