Major Changes To ACCME Standards; Proposed Comments by August 11, 2008
Continuing its efforts to increase the independence of
continuing medical education (CME), the ACCME announced last
month several clarifications and proposed changes concerning
its Standards for Commercial Support and enforcement
priorities. This announcement comes on the heels of a recent
acknowledgment that the ACCME met with Lewis Morris, Chief
Counsel of the Department of Health and Human Services Office
of Inspector General (OIG) "to further the ACCME's
understanding of government regulation in the U.S. and to gain
insights into the areas of interest of the OIG of
HHS."1 It also follows growing discussion
during ACCME Board of Director meetings concerning the need to
assure the independence of CME, particularly with regard to
content and speakers.
The June announcement continues ACCME's strong march
towards more rigorous enforcement of the relationship between
accredited CME providers and commercial supporters. In a series
of clarifications concerning existing standards, announcements
about its enforcement priorities, and major proposed policy
changes, the ACCME moves closer to a standard that prohibits
all communication on CME topics and content between accredited
CME providers and commercial supporters. These clarifications
and proposals will have a significant impact on the terms of
pharmaceutical and biotechnology company-sponsored CME.
Policy Clarifications/Pronouncements
ACCME states that, "[o]ur continued goal will be
no communications or interactions about the
activity between commercial supporters and any teachers,
authors, planners, or staff of the provider about
topic or content" (emphasis added). Though
ACCME adopted language in October 2007 prohibiting CME
providers from acting upon topic recommendations by
commercial interests, it was unclear how ACCME would
reconcile this position with its January 2007 response to
Senators Grassley and Baucus suggesting that discussion about
CME topics, albeit limited, is permissible. The June
announcement clarifies that there should be no interaction
between CME providers and commercial interests concerning CME
topics.
ACCME states that, "there is no role for
ACCME-defined commercial interests in the development or
evaluation of accredited CME activities. The process of
activity development must proceed absolutely
independently of the commercial supporter"
(emphasis added).
ACCME explains that, "Accredited Providers
cannot engage in dialogue or collaboration
with commercial supporters...
To continue reading
Request your trial